China Medical News

News archive

2019

February: China to cut taxes for rare-disease drugs

China's Ministry of Finance announced Friday VAT reductions for rare-disease drugs to lower the cost for patients with rare diseases and encourage development of the pharmaceutical industry.

Starting March 1, 2019, the VAT rate for the import of rare-disease drugs will be reduced to 3%, the ministry said in an online statement. VAT for the production and sale, wholesale and retail of rare-disease drugs will also be reduced to 3% from March 1.

A total of 21 rare-disease drugs and four active pharmaceutical ingredients will become first to enjoy the polices, according to the ministry. Currently, China has more than 20 million people with rare diseases, who have very few options in terms of treatment. (Source: Xinhua)

February: 9 first class new drugs approved in 2018

Thanks to a key research program, nine Class I new drugs have been approved in 2018, an official of the National Health Commission said Friday. Class I new drugs refer to those which have never been marketed in China or overseas.

Yang Qing, head of the health science, technology and education division of the commission, revealed the information at the launching ceremony of Tyvyt, a newly approved domestic cancer drug.

A special key program on developing new drugs was launched in 2008, which has supported over 1,900 projects and produced 38 Class I new drugs.

The central government has invested nearly 20 billion yuan (about 3 billion U.S. dollars) in the program, attracting another 200 billion yuan of investment from local governments and enterprises. (Source: Xinhua)

February: China green-lighted more cancer medicines in 2018

China's National Medical Products Administration (NMPA) approved 18 new cancer medicines in 2018, up 157% on 2017, said an NMPA official Tuesday. Cancer medicines accounted for 37.5% of the total new medicines approved in 2018, "a notable increase over previous years," said Wang Ping, chief of the division of medicine registration under the NMPA, at a press conference. "It takes 12 months on average for a new anti-cancer medicine to be approved by the NMPA, down from 24 months before 2018," Wang said.

Last year the Chinese government adopted a series of measures to speed up the approval of imported and domestically-developed cancer medicines. According to Wang, the government exempted imported medicines from quarantine at border ports so they could reach hospitals and pharmacies as quickly as possible. The approving procedure for imported medicines to enter the Chinese market, as well as that for domestic pharmaceutical firms to conduct clinical tests, were also simplified.

The NMPA and National Health Commission (NHC) listed 48 types of imported medicines that were much needed in China, including those for rare and deadly diseases. The review period of imported medicines for rare diseases is three months, while for the rest it is six months. "The country has tried to develop a favorable policy environment for innovation in medicines so that the latest medical research findings could benefit Chinese patients as soon as possible," Wang said.

This year the NMPA will work with the NHC to develop the second list of much needed imported medicines that are qualified for fast-track review, he said. The NMPA will also try to speed up the review procedure for imported and domestic cancer medicines and tighten up monitoring of adverse reactions, he added. (Source: Xinhua)

February: Talks aim to expand drug coverage by insurance

Most commonly used cancer drugs have been included in China’s basic medical insurance program, and the government is continuing negotiations on the price of expensive drugs with the aim of including them, the country’s top medical security authority said.

China has included 34 drugs that treat major cancers in the national basic medical insurance program after successful price negotiations with pharmaceutical companies in the past three years, the National Healthcare Security Administration said recently. The prices of most of the drugs have been cut by more than half, and patients will spend even less after reimbursement from the medical insurance fund, the administration said.

The pace of progress has been accelerating. Two cancer drugs were approved for inclusion in the medical insurance program after their prices were cut by more than 50 percent in 2016, while 15 were approved in 2017 and 17 were included in October. The administration also has recognized significant demand from patients with other serious diseases. It is considering engaging in price negotiations on drugs used to treat those patients this year, the administration said. “The number of patients with some other serious diseases such as heart disease and hepatitis B is also high, and they’ve also appealed for more affordable drugs,” it said. The administration said it will continue to try to include new cancer drugs in the program after they are proven effective.

There are an estimated 3.8 million new cancer cases in China every year, with cancer becoming a leading cause of death, with the incidence of some cancers, such as lung and breast cancer, rising rapidly, the Cancer Hospital at the Chinese Academy of Medical Sciences said in a report last year.

The National Medical Products Administration, China’s top drug regulator, said in January that it has accelerated inspection and approval procedures for new drugs developed overseas that are urgently needed by Chinese patients. A number of them, including cancer drugs, will be available on the domestic market this year.

In many European countries and the United States, price negotiations are routine between commercial insurance companies and pharmaceutical companies. But in China, such negotiations have been held between the government and pharmaceutical companies only in the past few years. (Source: China Daily)

January: China brings more new drugs to market with fast-track approval

China has adopted a fast-track approach in its drug evaluation and approval system, allowing more new domestic drugs, innovative drugs and imported drugs to hit the market in 2018. Last year, the Center for Drug Evaluation of State Drug Administration proposed to approve 59 imported branded drugs and 11 new domestic drugs, including two traditional Chinese medicines, according to an SDA statement. Nine of the 11 domestic drugs were first approved across the world.

Most of the newly approved were anti-cancer, antiviral and orphan drugs (drugs for the treatment of rare diseases). Among the approved ones, 18 were antineoplastic while many were for tumor indications, which will bring about more therapy alternatives for chemotherapy, the SDA said. The speedy approval of some specific medicines has enabled Chinese patients to receive better treatment. For instance, China in May approved Epclusa for the treatment of adults with chronic Hepatitis C virus infections, the latest treatment for the disease. China also created a special channel for clinical drug-trials, which previously took two to three years after application but is only 60 days currently, if no queries or negative feedback are returned to the applicants.

The SDA Center for Drug Evaluation has communicated more with drug enterprises in new drug research and development. As of Dec 10, the center had received and handled a total of more than 1,500 communication applications, the statement said.

Meanwhile, the SDA has accelerated the process to introduce clinically needed new drugs from overseas, with 10 types accessible at home now and more expected this year, it said.

China will continue deepening the reform of drug evaluation and approval, and will make more efforts such as simplifying the requirements for importing overseas drugs and encouraging the research and development of innovative drugs, it added. (Source: Xinhua)

January: Pfizer inaugurates pay-for-performance in China with money-back Ibrance deal

Lately, every day seems to bring new talk about "innovative" payment models for expensive drugs in the U.S. and Europe. Now, China's getting enthused, too.  Pfizer has launched the country’s first pay-for-performance program in oncology with its blockbuster breast cancer drug Ibrance, China Daily reported. Under the new program, called Bo’ai Xin’an, Pfizer promises reimbursement of up to 33.5% of Ibrance costs if an enrolled patient’s disease progresses within four months.

The U.S. pharma set up the project in collaboration with one of China’s largest commercial insurers, People’s Insurance Company of China (PICC) and MediTrust Health, a Shanghai-based firm that offers healthcare financing services. It’s a small, if groundbreaking, program. It will accept no more than 500 patients, and only those who haven't received hormone therapy are eligible. Patients must also join the program within 28 days of starting Ibrance, Biocentury reported. China runs a national healthcare scheme, and private insurance plans have only interested a few.

China is now the second-largest pharmaceutical market overall and will probably grow more important as drug reforms continue. Its medicine spending will reach up to $170 billion by 2023, from 2018’s $137 billion, according to an IQVIA report released Tuesday. But as access to medicines in general and new medicines in particular expands, the Chinese government is starting to feel the pressure from increased spending. Beijing has begun to crack down on drug prices, especially in the essential drug category, trying to make way for innovative drugs as a new, more streamlined review process ushers those new products to market faster.

And that's one reason why multinational pharma companies like Pfizer are turning more focus toward new drugs in the country. For example, in a new bulk purchase scheme China’s piloting, off-patent drugmakers offered steep discounts to win big tenders from major Chinese cities. As a result, foreign pharmas’ original drugs, Pfizer’s Lipitor included, were mostly defeated by local firms’ cheap copycats. (Source: FiercePharma)

January: China's population growth hits 57-year low

China's population growth rate has reached the lowest level in decades, according to data released by the National Bureau of Statistics on Jan 21. A total of 15.23 million babies were born last year on the Chinese mainland, a drop by about 2 million from that of 2017, according to data released by the NBS.

The population growth rate dropped from 532 to 381 per 100,000 population from 2017 to 2018, NBS figures show. The rate is the lowest since 1961.  It also marks the second year consecutive decrease since the country relaxed its family planning policy and fully implemented the universal second-child policy.

China adopted the universal second-child policy at the beginning of 2016, allowing all couples to have two children, to counter problems such as ageing and dwindling workforce. After the number of birth reached 17.86 million that year, the highest since 2000, the number of birth fell to 17.23 million in 2017.

Latest NBS figures also show that the total population on the Chinese mainland reached 1.395 billion, an increase of 5.3 million year-on-year. The number of people at 60 years old or above exceeded 249 million, accounting for 17.9% of the total population, according to the bureau. (Source: China Daily)

January: 48 overseas drugs set for patient use on Chinese mainland this year

China's top drug authority said it has been accelerating approval of new drugs researched and developed overseas, and a number of such new drugs will be available for patient use on the Chinese mainland this year.  The National Medical Products Administration released a list at the end of last year of 48 overseas new drugs, including 12 cancer drugs, for priority approval, and eight have been available in the domestic market, the administration said, China Central Television reported on Jan 14.  All these drugs are already available in overseas markets, and they are urgently needed by domestic patients, it said.

China has been simplifying inspection and approval procedures of overseas new drugs so they can be available in China more quickly. The administration would recognize data of clinical trials conducted outside China in the approval of new drugs, as long as their applicants believe the drugs will not cause different safety risks and effects to peoples of different races, according to a guideline released by the administration last year.

Previously, such data was not recognized by the administration, so lengthy clinical trials had to be conducted in China again before drugs could be approved, even though they had been available for use overseas for years. This was a cause for delay in the availability of many new drugs in the Chinese market. (Source: China Daily)

January: Hospitals get access to new cancer drugs

The latest 17 cancer drugs included in China's national basic medical insurance program in October are now available in more than half of all major hospitals in China, the top health authority said on Jan 10.

The National Health Commission instructed major hospitals across China in late October to buy the drugs as quickly as possible so patients will not have to wait, Song Shuli, spokeswoman of the National Health Commission, said at a news conference.

As of early January, 1,257 tertiary hospitals and 129 cancer hospitals in all 31 provinces, autonomous regions and municipalities on the Chinese mainland had bought at least one type of the drugs, with more than 600,000 boxes of drugs being used by patients, she said. "Availability of the cheaper drugs has greatly eased the financial burdens of some cancer patients," Song said. "We will continue to encourage hospitals to buy these drugs to improve cancer patients' access to them." The number of tertiary hospitals on the Chinese mainland was 2,460 as of the end of September, according to the commission.

The 17 cancer drugs, many of them imported, treat major cancers such as lung, rectal and kidney cancers, and are in high demand by patients in China. They were included in the national basic medical insurance program in October after price negotiations organized by the National Healthcare Security Administration, which resulted in prices falling by 57% on average. Patients would spend even less on the drugs after reimbursement from the medical insurance fund.

Many patented drugs, including cancer drugs, were sold at higher prices on the Chinese mainland than in most other countries for various reasons, such as higher circulation costs and lack of research and innovation ability among domestic producers, which caused a public outcry for a reduction of prices. Moreover, many of the cancer drugs were not available at the hospitals before, as they were not included in the basic medical insurance program. Li Guohui, director of the Pharmacy Office of the Cancer Hospital of the Chinese Academy of Medical Sciences, said "Now many cancer patients can have access to drugs that they could not find or afford before, and they have more choices of drugs". (Source: China Daily)

January: China's homegrown anti-cancer drug wins international recognition

China's homegrown drug sintilimab designed for treating relapsed or refractory classic Hodgkin lymphoma has won international recognition, with its clinical trial research published as the cover paper in the January issue of The Lancet Haematology.

Hodgkin lymphoma is a rare malignant lymphoma that occurs mostly in young people between the ages of 20 and 40. Although the cure rate of early treatment is high, patients have a 20% chance of recurrence after their first treatment. Patients with relapsed or refractory classic Hodgkin lymphoma lack effective treatment in China.

Sintilimab, an anti-PD-1 drug, is a type of checkpoint inhibitor, an emerging anti-cancer therapeutic modality that boosts the immune system to help the body target and kill tumors.

Professor Shi Yuankai from the Cancer Hospital, Chinese Academy of Medical Sciences, led the clinical research, which enrolled 96 patients with relapsed or refractory classic Hodgkin's lymphoma from 18 hospitals in China. Results showed that Sintilimab has favorable activity and acceptable toxicity in Chinese patients with relapsed or refractory classical Hodgkin lymphoma, with 80.4% of the patients showing an objective response.

Stephen M Ansell from the Division of Hematology at the Mayo Clinic commented that Sintilimab is a "highly effective treatment which potentially improves the outcomes of patients with classical Hodgkin lymphoma worldwide."

Sintilimab was approved for market authorization by China's National Medical Products Administration in December 2018. "The approval will bring more treatment options for cancer patients in China," Shi said. (Source: Xinhua)

January: China to encourage production of generic drugs

China will publish a list of generic drugs before the end of June and encourage pharmaceutical companies to research and produce them. The list will be updated at the end of every year starting from 2020, according to a work plan jointly issued by 12 government departments including the National Health Commission.

Key generic technologies of major chemical and biological medicines on the list will be incorporated into national plans for research and development, said the plan. The plan also promised to prioritize the approval of generic drugs on the list and ensure they have the same quality and effect as their branded counterparts.  (Source: Xinhua)

2018

December: Price of generic drugs halves in pilot 'group-buying'

Compared with 2017, the prices of 25 generic drugs dropped by an average of 52% thanks to a pilot procurement in 11 major Chinese cities, the organizer said on Dec 8.

As a major reform of the current centralized procurement system, the pilot program asked the participating cities to specify the quantity of each purchase, to give the manufacturers a clearer expectation. Previously, the bidding usually only determined the price, but could not guarantee the purchase quantity. The 11 participants of the program, including Beijing, Shanghai, Guangzhou and Shenzhen, account for about one third of the national market.

November: New breast cancer drug now available in China

Advanced breast cancer patients in China now have another treatment option other than chemotherapy to choose from following the approval of a new oral drug by the China Food and Drug Administration called IBRANCE® (palbociclib). Developed by US-based pharmaceutical company Pfizer, Ibarnce is presently available to patients in 35 Chinese cities.

According to Dennis Slamon, one of the lead scientists in the development of Ibarnce who visited Shanghai in October, the consumption of the pill does not have severe side effects like chemotherapy such as hair loss, nausea and vomiting.

Breast cancer is ranked as the most common form of cancer in women in China. According to the 2017 China Cancer Registration Annual Report released by the National Cancer Center, there are about 280,000 new cases each year. The report also showed that about one-tenth of patients already suffer from advanced breast cancer when diagnosed, while about one-third of those who detect the condition early and have undergone surgery or standardized treatment will still develop advanced breast cancer. The five-year survival rate of advanced breast cancer is only about 20%.

Slamon said he hopes the drug, which can effectively stop cancer cells from proliferating, can bring more hope to Chinese patients as it has done in the US, where it was approved in 2015. The scientist also hopes that the availability of this new drug in China might inspire Chinese physicians to come up with different treatment combinations. The drug is also being tested in early breast cancer, according to Slamon, who added that China is included in its worldwide clinical trials.  Pfizer is also collaborating with major university centers in Dalian, Liaoning province, Beijing and Shanghai in the research and development of treatments for early breast cancer patients, said Slamon. (Source: China Daily)

November: HIV/AIDS rate at low level in China

Around every nine in 10,000 people are living with HIV/AIDS in China, a low rate compared to other countries, according to the National Health Commission (NHC).

Sexual intercourse is the main channel for contracting HIV in China, the health authority told a press release on Nov 23. However, China has essentially prevented the spread of HIV through blood transfusions, with nearly zero cases of infection recorded through this channel and through using other blood products, the NHC added.

Wang Bin, an NHC official in charge of disease prevention and control, said that HIV transmission through injective drug use has also come under control, with reported cases of HIV contraction via drug injection in 2017 seeing a 44.5% decrease compared to 2012. Meanwhile, the rate of mother-to-child transmission declined from 7.1% in 2012 to 4.9% in 2017, Wang added.

The NHC has been stepping up efforts in HIV testing and discovering HIV-infected people, said Wang, adding that a total of 200 million people in China had HIV tests last year, double that in 2012.

Some 80.4% of people living with HIV/AIDS in China received anti-virus treatment in 2017, with the treatment success rate standing at more than 90%, the official said.

Noting that HIV/AIDS prevention and treatment is still arduous, Wang said the NHC will strengthen efforts in warning and educating people at risk of contracting HIV, promoting one-stop services for testing, consultation, diagnosis and treatment, and mobilizing social forces, including enterprises, funding bodies, health organizations and volunteers, to participate in the fight against the disease.

According to a joint evaluation by the Chinese Center for Disease Control and Prevention, UNAIDS and the World Health Organization, there are around 1.25 million people living with HIV/AIDS in China by the end of this year, and 80,000 newly-infected people every year. (Source: Xinhua)

November: China’s national drug procurement pilot officially begins

On November 15th, Shanghai Pharmaceutical Centralized Bidding and Purchasing Management Office published a document called "4 + 7 City; Drug Centralized Procurement Document” which outlined the application procedures and requirements for the drug manufacturers.

According to this document, with the approval of the Central Comprehensive Reform Committee, the state organized a pilot program for centralized drug procurement, which included 11 cities; Beijing, Tianjin, Shanghai, Chongqing, Shenyang, Dalian, Xiamen, Guangzhou, Shenzhen, Chengdu, and Xi'an (the 4+7 cities). Representatives from the pilot areas will form a Joint Procurement Office as a working organization to implement centralized drug purchasing on behalf of the public medical institutions in the pilot areas. The daily work and specific implementation will be undertaken by the Shanghai Pharmaceutical Centralized Bidding and Purchasing Management Office.

There are 31 drugs listed in the centralized procurement catalogue, and the largest purchase volume is the 5mg amlodipine oral regular release dosage form (293 million tablets), and the smallest purchase volume is the 500mg pemetrexed injection (22,900 pieces). The Joint Procurement Office will accept applications from December 6, 2018, and the negotiations will begin on the same day. (Source: Shanghai Sunshine Medical procurement All-In-One website)

November: Birth rate continue to decline, despite two-child policy

The number of births in China is expected to continue to fall this year, the third year of the implementation of a national policy designed to encourage couples to have a second child, according to president of the China Population Association.

"The number of people born will undoubtedly continue to fall this year, as well as over the next few years," Zhai Zhenwu, who is also a prominent professor in population studies in Renmin University of China, said. Zhai, president of the China Population Association, said a major reason for the declining birth rate is the rapidly decreasing number of women of childbearing age, which has kept going down by between 5 million and 6 million every year. "So even if the birth ratio remains the same, the total number of people born will keep decreasing," he said.

Another reason for the expected decline of births is that many women who planned to have a second child rushed to get pregnant and give birth in the first several years of the implementation of the policy, and the peak in births will be over soon, Zhai said.  However, Zhai said the universal second child policy has helped to increase the birth rate, and the number of second children born in China has accounted for about half of all the births in China last year.  "Without the universal second child policy, the number of births would see a more drastic fall," he said.

Zhai suggested creating a friendlier environment for couples to give birth, such as establishing more nurseries for infants, to encourage the birth of a second child. "However, we should realize the fact that various measures designed to encourage births will not stop the dwindling birth rate, as experiences in some developed countries such as Japan and South Korea have shown," he said. (Source: China Daily)

October: 17 cancer drugs added to insurance program list

China has included 17 more cancer drugs in its national basic medical insurance program, the latest progress in government efforts to make drugs more affordable for cancer patients.

The patented drugs are among 44 cancer drugs selected by the National Healthcare Security Administration in June for negotiations on lowering their prices and inclusion in the list of drugs eligible for reimbursement through the medical insurance program, the administration said on Oct 10.

The retail prices of the 17 drugs will fall by about 57% on average, and most of the imported drugs will become cheaper than in neighboring countries and regions, the administration said. For example, the price of Erbitux, a drug produced by German pharmaceutical company Merck to treat rectal cancer, has been reduced to 1,295 yuan ($187) a bottle, down from around 4,200 yuan last year.

As the drugs will become reimbursable after being included in the medical insurance program, patients are expected to spend even less on them, the administration said. (Source: China Daily)

Full list of 17 drugs to be covered by China's national insurance (Source: FiercePharma)

 

 

 

 

 

 

October: China's health literacy rate, higher in 2017

China's health literacy rate edged higher in 2017 to 14.18%, a 2.6% increase than that of 2016, as China is making steady progress in health literacy promotion, the National Health Commission said. Health literacy refers to one's ability to gain and comprehend health information and acquire relevant services to make appropriate health decisions, while health literacy rate means the ratio of people possessing such abilities. The results were based on a nationwide health literacy test, the seventh one conducted in China, which covered 85,000 individuals in 31 provincial regions.

In terms of health knowledge, healthy lifestyles and basic health-related skills, the health literacy rate of Chinese citizens is 25.82%, 14.30% and 16.38%, respectively. The commission said that it plans to step up efforts in health education in rural areas and among children. (Source: Xinhua)

September: Police to help hospitals reduce patient disputes

Public security departments will improve cooperation with health authorities to reduce medical disputes between patients and hospitals, Li Jingsheng, chief of security administration at the Ministry of Public Security, said at a conference on Sept 26 with several departments.  They will not tolerate violence against medical workers or the disruption of hospital operations, such as holding condolence ceremonies for deceased relatives in the hospital or blocking entrances, Li said.

A regulation by the State Council, China's Cabinet, that takes effect on Sept 24, is aimed at protecting the rights of patients and medical workers when disputes arise over medical services. Patients should resolve disputes with medical workers or institutions through legal means, including negotiations through a third party or through the courts, according to the regulation. (Source: China Daily)

September: Keytruda in China at half price vs U.S.

When Bristol-Myers Squibb unveiled its price for Opdivo in China (set at around $1,350 for the 100mg/10mL vial, nearly half the U.S. cost of approximately $2,600), industry watchers considered it a benchmark against which future immuno-oncology therapies will look to for their pricing strategies. Now it appears at least its arch rival, Merck & Co., has taken note for PD-1 competitor Keytruda.

The New Jersey pharma has priced Keytruda at 17,918 Chinese yuan ($2,600) per 100mg/4mL vial in China on the retail front, local business media organization Caixin reported. Compared with the drug’s U.S. price of around $4,800, that’s a 46% discount—about the same taken by Opdivo—and is also about 70% of its Hong Kong price.

In addition, Merck is rolling out a patient assistance program (PAP) that will offer patients three additional months of free treatment after they pay for the first three, according to Caixin. Opdivo’s reported PAP entails six months of free drugs after five.

Keytruda was approved in the emerging market in late July. While Opdivo directly went after the lucrative lung cancer market for its first China indication, Keytruda is now approved there in advanced melanoma, even though it has already shown the ability to slash lung cancer death risk by half when paired with chemo in first-line use.

Both drugs will likely have a hard time getting onto the country’s national insurance scheme. For one thing, their costs might still be a burden on healthcare expenditure after steep discounts; second, Professor Yilong Wu, who led Opdivo’s Chinese-specific phase 3 trial, has said PD-1s are less predictive of the most suitable patients compared to targeted therapies, meaning the government will likely favor the latter for coverage.

In the second quarter, Keytruda overthrew Opdivo as the new PD-1/L1 king, with $1.67 billion in quarterly sales, versus Opdivo’s $1.63 billion.

Several domestically made checkpoint inhibitors might soon join the fray. Junshi Biosciences has also filed its PD-1 for approval in melanoma, and Jiangsu Hengrui Medicine and Innovent Biologics await Chinese decisions as well. (Source: FiercePharma)

September: Rules issued for online medical advice

Patients seeking medical treatment in China now need to receive a diagnosis in person from a doctor at a hospital before they can access online consultation services, according to new regulations aimed at improving supervision of the nascent internet healthcare industry.

The rules also require online service providers to have cooperation agreements with brick-and-mortar hospitals and say that health professionals must read a patient's medical records before they consult or prescribe medicine over the internet.

The National Health Commission, which released the regulations on Sept 14, said medical consultants need at least three years of clinical experience in order to provide web services, and only prescriptions for common illnesses and chronic diseases are allowed to be issued online.

The use of telecommunications and information technology to offer clinical care from a distance-known as telemedicine-has already helped improve access to healthcare for those living in remote communities. Huang Yong, deputy director of the West China Hospital of Sichuan University, said a telemedicine program operated by the university in the Garze Tibet autonomous prefecture, Sichuan province, has saved about 90% of patients with hepatic hydatid-a liver disease caused by tapeworm-from traveling long distances to other provinces for proper treatment. "The number of patients being diagnosed and treated locally has increased by five times since the launch of the program," he said, adding that telemedicine channels high-quality medical resources to communities with less-advanced services.

The online medical consulting market has grown rapidly in China, with more than 1,000 companies formed between 2011 and 2016, according to a report by financial news outlet Yicai citing figures from the founder of an online medical services platform. The report added that at least 200 billion yuan ($29.1 billion) had been invested in the market in the past four years. (Source: China Daily)

September: China to release updated essential medicines list

China's National Health Commission on Sept. 5 announced its recent plan to publish the 2018 National Essential Medicines List, which will cover 165 more medicines than the prior edition. The updated list will have 685 medicines, made up of 417 Western medicines and 268 Chinese-patented medicines, Zeng Yixin, vice director of the commission, said at a press conference. The latest edition of the list was published in 2012, covering 520 medicines.

The new edition of the list, focusing on cancer as well as pediatric and chronic diseases, has added 12 antitumor drugs, 22 medicines for children, and a new hepatitis C drug, Zeng said. "Covering a wider range of medicines, the updated list can not only meet clinical needs such as the treatment of common and chronic diseases as well as first aid but also offer multiple options for patients with different diseases," he said. (Source: Xinhua)

August: Cancer drug prices set to drop

Pharmaceutical companies are taking positive steps to reduce prices of cancer drugs in response to tariff exemptions and value added tax reductions to improve access to medicines and reduce the financial burden on patients. China removed import tariffs on cancer drugs from May 1 and lowered VAT from May 3. According to Voice of China, it is estimated that the moves will save patients about 1,000 yuan ($145) a year on average.

On July 25, domestic pharmaceutical enterprise Betta Pharmaceuticals Co Ltd announced that it has reached an agreement with the Ministry of Human Resources and Social Security to lower the price of its product, which combats lung cancer, from 1,399 yuan to 1,345.05 yuan per box.

"The nation has been promoting price cuts of anti-cancer drugs to make drugs more accessible and affordable to the public," Rong Di, deputy director of the Department of Pharmaceuticals at the China Chamber of Commerce for Import& Export of Medicines & Health Products, said during an interview with Securities Daily. "Enterprises - both foreign and domestic - have lowered the prices of products to answer the call from the government. Meanwhile, it is also part of the companies' development strategies."

Xian Janssen Pharmaceutical Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, said it will cooperate with central and local authorities to adjust the prices of some of its innovative medicines in China, in response to the State Council's tariff exemption and VAT reduction policies. "We welcome and support the positive steps taken by the Chinese government to accelerate patients' access to innovative oncology medicines. Our commitment is to ensure cancer patients receive timely access to our treatments and we continue to work with external stakeholders to explore innovative solutions to improve access of those patients most in need," a company spokesperson told China Daily.

Regions in China are also actively responding to the nation's appeal. On July 30, the Health and Family Planning Commission of Hunan Province published a notice stating that enterprises are encouraged to actively submit applications for price adjustments of imported anti-cancer drugs. "Price cuts cannot be lower than the tariff cut," the notice said.

Guangdong Medicine Exchange also issued a guideline to urge pharmaceutical enterprises to submit declarations of anti-cancer drug prices, covering 646 types of medicine, among which 84 are imported.

To date, 15 provincial regions, including Shaanxi, Jiangxi, Hainan, Henan, have joined the action. (Source: China Daily)

August: China develops new diagnostic method for coronary heart disease

Chinese scientists have developed a new diagnostic method for coronary heart disease which has a 33% higher accuracy rate compared with conventional methods.

Developed by Shanghai Jiaotong University, the new technology is called Quantitative Flow Ratio (QFR) measurement system and has been approved by the China Food and Drug Administration.

A coronary angiography is the most conventional diagnostic method of coronary heart disease in China. However, the internationally recognized high-precision assessment technology is expensive and requires complex surgical procedures, which have not been popularized in China. Based on the computational analysis of an X-ray coronary angiography image, the system obtains the QFR, which can help identify coronary heart disease. The new method does not require additional surgeries or drugs.

A clinical study led by Fuwai Hospital of the Chinese Academy of Medical Sciences showed that the new method could assess coronary function within four minutes, and had a 33% higher accuracy rate compared with a coronary angiography.

"The new method will assist doctors in identifying coronary heart disease and assist in making treatment plans, such as whether the patient needs a heart stent implantation", said an expert from Shanghai Jiaotong University.

According to statistics from the National Cardiovascular Center, there were 290 million cardiovascular patients in China in 2017, including 11 million patients with coronary heart disease. (Source: Xinhua)

August: China to include more cancer drugs on medical insurance list

China will make more cancer drugs affordable, as a new round of negotiations between the country's state medical insurance administration and pharmaceutical companies to add such drugs to the medical insurance list is scheduled to finish by the end of September.

The administration said it has selected a range of drugs to be added and is confirming the producers' willingness to further negotiate. All of these drugs are of great clinical value and will bring huge benefits to patients with different blood cancers or solid tumors, including colorectal cancer, renal cell carcinoma, lymphoma, and chronic myelogenous leukemia, said the administration.

China has exempted import tariffs from all common drugs including cancer drugs, cancer alkaloid-based drugs, and imported traditional Chinese medicine since May 1.

Based on the new policy, 12 pharmaceutical companies have recalculated the prices of their products and will submit applications for price adjustments on the requirement of the administration.

A negotiation launched in 2017 has lowered the prices of 15 clinically-effective yet highly-priced cancer drugs such as Heceptin, Rituximab, and Bortezomib, as well as added them to the medical insurance reimbursement list. Prices of some medicines have dropped remarkably. In Hunan Province, the price of each vial of Herceptin decreased from 17,600 yuan to 7,600 yuan, and the price of each vial of Fulvestrant, also used to treat breast cancer, dropped from 11,500 yuan to 4,800 yuan.

The newly-formed State Medical Insurance Administration said it would further cut the price of cancer drugs on the list via public bidding and procurement. (Source: Xinhua)

August: China targets 45 drugs for priority approval

Aiming to speed new drugs to market, China just came up with a target list of 48 treatments greenlighted abroad, including some of the industry's biggest names. Some key new drugs are on this list, including Roche and Chugai’s ALK cancer drug Alecensa, psoriasis therapies Taltz by Eli Lilly and Cosentyx from Novartis, and Takeda’s anti-inflammatory treatment Entyvio. Even a few drugs just approved in the U.S. last year were ID'd as targets, including GlaxoSmithKline’s shingles vaccine Shingrix, Spark Therapeutics’ eye therapy Luxturna and Ultragenyx’s Mepsevii.

The list of "clinically urgently needed new drugs" was developed by experts convened by China’s State Drug Administration. The group mainly considered medications already approved in the U.S., EU and Japan, but not yet marketed in China. According to the agency’s Center for Drug Evaluation, the country is in urgent need of these drugs to fight rare diseases or life-threatening conditions, because no effective treatment exists in China or because they've shown clear advantages in clinical studies.

Some of the drugs on the list are already on their way to the Chinese market. Merck’s PD-1 star Keytruda, for example, was just waved through a few days ago to treat advanced melanoma patients. AstraZeneca, for one, has filed its PARP inhibitor Lynparza for approval. As for the others yet to make a bid for approval, the agency says drug developers can apply using foreign data and evidence that supports no racial or ethnic differences in efficacy or safety. Once accepted, their new drug applications will be put under priority review.

China has taken major steps to speed up its drug review process and reduce its backlog of applications. Lynparza, for example, was the first drug to be filed using data from multicenter trials that included China sites, without the usual application to waive a China-specific clinical trial. Keytruda was approved under an accelerated approval process.

The country’s drug regulator also started offering conditional marketing authorizations. Merck’s HPV vaccine Gardasil 9 was handed a conditional nod in May based on foreign clinical data. It took the agency only nine days to make the decision. (Source: FiercePharma)

July: China to complete standardizing urban, rural medical insurance by 2019

A unified national medical insurance service, from which both urban and rural residents enjoy equal benefits, will be in place by 2019, said the State Medical Insurance Administration on July 25.

In a notice jointly issued by the ministries of Finance, Human Resources and Social Security, the National Health Commission and the administration, local governments that have not started such service were urged to seize the moment and prepare themselves to put it into operation as soon as possible.

Rural residents in China used to have a medical insurance scheme with far inferior to their urban counterparts. The government started to standardize rural and urban schemes in 2017.

Each citizen receives the minimum 490 yuan (about $72) from the government in his or her medical insurance account a year on average and is required to deposit 220 yuan from his or her pocket.  Both figures are 40 yuan higher than 2017. (Source: Xinhua)

July: China's air pollution control brings health benefits

China's action plan on air pollution prevention and control has generated great health benefits, according to a recent research. China issued the Air Pollution Prevention and Control Action Plan in 2013 and accomplished all the major tasks set out in the action plan last year.

Researchers from Peking University's School of Public Health analyzed national air quality monitoring and mortality data to estimate the health impact of air pollution control in 74 Chinese cities from 2013 to 2017.

The result showed that annual average concentrations of PM2.5, PM 10 and sulfur dioxide dropped by 33.3%, 27.8%, and 54.1%, respectively, in the 74 cities between 2013 and 2017. In 2017, there were 47,000 fewer deaths and 710,000 fewer years of life lost attributable to air pollution in the 74 cities than those in 2013, a substantial improvement for public health.

China released a three-year action plan on air pollution control in July, solidifying a timetable and roadmap for improving air quality. According to the plan, China's air quality and people's satisfaction with it should significantly improve over the next three years. (Source: Xinhua)

July: Top Chinese rabies vaccine maker ordered to stop production over forged data

China’s drug regulator just pulled a manufacturing permit for the country’s second-largest maker of rabies vaccines over data falsification, marking the latest episode in China’s drug safety scandal.

During an inspection, China’s State Drug Administration found Changchun Changsheng Life Sciences forged production records for its Vero cell-based rabies vaccines. The agency immediately moved to revoke the company’s GMP license tied to the vaccine—just three months after its issuance—and dispatched a team to investigate the incident on site.

In its announcement filed to Shenzhen Stock Exchange, the Changchun, China-based company said it has started recalling all unexpired rabies vaccines, even though the batches under question weren’t released to the market, and it hasn’t received any adverse event report related to the quality of the vaccines through years of monitoring.

The company claims to be China’s second-largest rabies vaccine supplier, having delivered 3.55 million courses of the five-dose-per-course freeze-dried vaccine in 2017, making up about a quarter of the market, according to the firm’s annual report.

Changsheng’s recent scandal comes eight months after a batch, or 252,600 doses, of its diphtheria/tetanus/pertussis (DTP) combo shot was found below the potency requirement. It also comes shortly after the company became one of the first two companies to get Chinese approvals for quadrivalent flu vaccines. Besides rabies, DTP and flu vaccines, Changsheng also sells vaccines against chickenpox, hepatitis A and group ACYW meningococcal. A small proportion of its business comes from abroad, including India, Cambodia, Egypt and Belarus, among others. It’s not yet clear whether it sells its rabies vaccines outside of China.

China has taken a hardball policy to safeguard vaccine safety after a high-profile scandal in 2016. At that time, a ring led by a mother and daughter team in Shangdong province was found to have illegally sold millions of dollars’ worth of vaccines across the country without following proper storage and distribution requirements. Vaccines made by some of the country’s top makers were involved, over 100 people have since been handed criminal sentences, over 300 government officials were removed or punished, and most importantly, it hurt the public’s confidence in Chinese-made vaccines.

After that, China banned middlemen in vaccine distribution, asking provincial CDCs to buy vaccines directly from manufacturers, and established a better vaccines tracing system. (Source: FiercePharma)

July: Beijing's life expectancy rises to 82.15 years

A paper released by the Beijing Municipal Government on July 11th said that the premature death rate for major chronic diseases of people aged between 30 ~ 70 was 10.8% in 2017, a decrease of 0.92% from 2016. The paper also said that the average life expectancy of Beijing residents rose to 82.15 years in 2017, more than five years higher than the national average.

The main cause of death was chronic non-communicable diseases. Tumors, heart disease and cerebrovascular disease were the top three, accounting for 71.7%. In 2017, the mortality rate for Beijing residents with tumors increased to 183.8 cases per 100,000 people, accounting for 26.9% of total deaths, up 3.6% from 2016.

A deputy director of Beijing's Center for Disease Control and Prevention, said the rise of chronic diseases was attributed to an aging population, and changes in environment and people's lifestyle, such as lack of exercise, unhealthy diets and obesity.

The paper also reported progress in establishing a hierarchical medical system, saving 6.74 billion yuan (about one billion U.S. dollars) in medical expenses. This year, the municipal government plans to promote a health assessment service in the city and provide fitness guidance for residents. (Source: China Plus)

June: Survival rate of liver transplant recipients rises in China

According to a press conference held by the National Health Commission on June 22, the five-year survival rate of liver transplant recipients in China rose from around 59% in 2014 to 71% in 2017.  The one-year survival rate and three-year survival rate of liver transplant recipients in China reached 84% and 75% respectively, on a par with the international standard, said Guo Yanhong, an official with the commission.

Guo said China conducted 4,732 liver transplant operations in 2017, up over 26% year on year. Among them, 4,138 came from donations after cardiac deaths. The current average waiting time for a liver transplant in China is 27.5 days, compared with 120 days needed in the United States, according to Guo. (Source: Xinhua)

June: Over 600,000 Chinese went overseas for medical treatment last year

Science and Technology Daily reported that over 600,000 Chinese people sought medical treatment overseas last year. Statistics show that 80% of those people were cancer patients.

Figures released at this year's Cancer Awareness Week show a 5-year survival rate of 30% for patients in China, while it can reach 70%-80% in developed countries.

While cancer diagnosis in China is still in its primary stage, its cancer treatment is just as good as that in the United States; and Chinese doctors are usually more experienced than their American counterparts, according to Sun Yan with the Chinese Academy of Engineering.  However Sun does admit that China is lagging behind the United States in drug research and development.

He Jie with the Academy says whether it's necessary to go abroad for medical treatment depends on the illness. Common cancers such as lung cancer can be treated in China with a comparable prognosis.

Zheng Shanhai from China's Meitan General Hospital published an article warning Chinese patients about the risks of going abroad for cancer treatment. Most of them seek the help of a third party due to language barriers and the agencies are usually not certified to provide such services. (Source: China Plus)

June: More than 450 million Chinese are myopic

More than 450 million Chinese suffer from myopia (nearsightedness), according to statistics made public on the first week of June. "The myopia rates are around 30% for primary school students, 60% for junior middle-school students, 80% for senior high middle-school students, and 90% for college students," said Long Qin, professor of the ophthalmology department of Peking Union Medical College Hospital, at a press conference held by the National Health Commission.

"The Chinese are suffering myopia at an earlier age with higher diopters, and the population of myopia sufferers keeps growing," said Wang Ningli, director of the ophthalmology department of Beijing Tongren Hospital, at the conference.

According to Jiao Yahui, an official with the commission, myopia has become an increasingly severe problem among children and a major public health issue. "Relevant departments released guidelines for myopia prevention in 2016, proposing requirements for lighting, desks and blackboards in classrooms, for students using computers and their daily study time," Jiao said. "Since 2016, relevant departments have been strengthening monitoring of the eyesight of students of different ages in some cities, and the scale of the monitoring will be expanded this year."

The commission Tuesday released a new guideline for preventing and curing myopia, offering guidance for medical institutions and personnel to enhance their service and help students and parents raise awareness of using their eyes correctly.  Noting that many people had undergone laser surgery for curing myopia, Long said the effect of the surgery was good, but advised patients not to take the surgery until they were 18 years old and only if their diopters remained stable for over two years. (Source: Xinhua)

June: Beijing's smoking population drops by 200,000

According to the municipal health authority in Beijing, the number of smokers in Beijing has dropped by about 200,000, three years after the city adopted its strictest tobacco control regulation. The city's commission for health improvement said that the adult smoking rate in Beijing is now 22.3%, or 3.99 million smokers, which is 200,000 less than the figure in 2015.

A total of 61 hospitals have opened smoking cessation clinics. The number of tobacco control volunteers has approached 15,000 citywide. About 1,600 departments and over 7,300 individuals were punished over violations of tobacco control regulations.  Medical establishments, schools and hotels have a relatively high compliance rate for smoking control regulations, while small restaurants, office buildings and entertainment venues continue to pose difficulties for the regulators. (Source: Xinhua)

May: China overtakes U.S. for healthy lifespan: WHO data

China has overtaken the United States in healthy life expectancy at birth for the first time, according to World Health Organization data. Chinese newborns can look forward to 68.7 years of healthy life ahead of them, compared with 68.5 years for American babies, the data - which relates to 2016 - showed. American newborns can still expect to live longer overall - 78.5 years compared to China’s 76.4 - but the last 10 years of American lives are not expected to be healthy.

“The lost years of good health that are a factor in calculating healthy life expectancy at birth are lower for China, Japan, Korea and some other high income Asian countries than for high income ‘Western’ countries,” said WHO spokeswoman Alison Clements-Hunt.

The United States was one of only five countries, along with Somalia, Afghanistan, Georgia and Saint Vincent and the Grenadines, where healthy life expectancy at birth fell in 2016, according to a Reuters analysis of the WHO data, which was published without year-on-year comparisons in mid-May.

The best outlook was for Singaporean babies, who can count on 76.2 years of health on average, followed by those in Japan, Spain and Switzerland. The United States came 40th in the global rankings, while China was 37th. In terms of overall life expectancy China is also catching up with the United States, which Reuters calculations suggest it is on course to overtake around 2027.

“Chinese life expectancy has increased substantially and is now higher than for some high-income countries,” said Clements-Hunt. Meanwhile U.S. life expectancy is falling, having peaked at 79 years in 2014, the first such reversal for many years, Clements-Hunt said. That reflected increasing rates of drug overdose deaths, mainly from opioids, suicides, and some other major causes among younger middle-aged Americans, particularly in less affluent areas, she said.

The world’s longest life expectancy is in Japan, at 84.2 years, meaning that babies born there in 2016 were the first to be able to look forward to seeing the next century. (Source: Reuters)

May: China to further cut import tariffs for daily consumer goods

Further to import tariffs on imported drugs being exempted from May 1st, the State Council decided that China will further cut import tariffs for daily consumer goods starting July 1.

The average tariff rate for detergents, cosmetics such as skin care and hair care products, and some medicine and health products will be cut from 8.4% to 2.9%.  The average tariff rate for clothing, shoes and hats, kitchenware, and sports and fitness supplies will be reduced from 15.9% to 7.1%, and that for home appliances such as washing machines and refrigerators from 20.5% to 8%.  The average tariff rate for cultured and fished aquatic products and processed food such as mineral water will be cut from 15.2 percent to 6.9 percent, according to a statement released after the meeting.

The cabinet called the tariff cuts a move conducive to expanding opening-up, meeting the demands of the people and boosting quality and industrial upgrading.

China will roll out a series of measures to create a fairer, more transparent, and easier investment environment for foreign-funded companies, including relaxing market access, enhancing investment facilitation, and better protecting legitimate interests of foreign investors, said the statement. (Source: Xinhua)

April: New domestic lung cancer medicine offers hope

Late-stage lung cancer patients who have built up a tolerance to some drugs may have new hope thanks to a domestically developed medicine, doctors from Shanghai Chest Hospital said on April 19.

Clinical trials showed that by using a small molecular, multi-targeted drug called anlotinib hydrochloride, the lives of lung cancer patients could be prolonged an average of 50% over patients receiving placebos. They survived another 3.3 months on average, said Han Baohui, who led the clinical trials that involved 437 patients at 34 health centers and hospitals nationwide.

Han is director of respiratory medicine at the hospital, which carries out some of the country's most advanced lung cancer diagnoses and treatments. The treatment, which inhibits the growth of tumors and the development of surrounding blood vessels, will be available to the general public this year, he said.

"One headache for doctors around the world is that there is no guide for how to prescribe medicines for late-stage patients who build up tolerance to various medicines after taking them for long periods," Han said, adding that most doctors prescribe based on what's worked for them in the past. The new treatment "may become a standard in our country as a viable prescription for these patients", he said, adding that the cost of taking the medicine is estimated at around 10,000 yuan ($1,600) per month.

According to China's National Cancer Center, 4.29 million new cancer patients are diagnosed in the country annually, with lung cancer ranked first among all cancers in both rate of occurrence and mortality. (Source: China Daily)

April: Nearly 100 million Chinese have chronic pulmonary disease

A national study has found that China has nearly 100 million people with chronic obstructive pulmonary disease (COPD). The findings made the respiratory condition among the country's biggest public health concerns, said the report.

According to the study published recently in the international medical journal The Lancet, 8.6% of nearly 51,000 participants 20 years or older had the disease, with the elderly and smokers at higher risk. More than 40% of smokers over 60 have COPD.

People with COPD are more likely to develop heart disease, lung cancer and many other health conditions. "The study further alerts us to the severity of COPD, an underestimated health threat here, and one that is expected to rise further due to the heavy smoking epidemic and aging trend," said Wang Chen, a top Chinese respiratory disease expert who leads the study.

Numbers from China's National Health Commission showed that COPD killed more than 870,000 Chinese in 2016, about 9% of disease-related deaths. (Source: Xinhua)

April: Pharmaceuticals made overseas will be exempt from import taxes, which will ease burden for China's patients

According to the statement released after an executive meeting of the State Council on Thursday (April 12th), from May 1, import tariffs on all common drugs including cancer drugs, cancer alkaloid-based drugs, and imported traditional Chinese medicine will be exempted. Also, value added tax in the production and import of drugs will drop by a large margin, which experts believe will be more effective in easing the economic burden of patients.

With various measures taken into consideration, it is estimated that the policies will lower the drug prices by at least 20%, said Shi Luwen, director of the international research center on medicine management at Peking University. The measures will significantly enhance the availability and inclusiveness of the drugs, reduce the burden of patients' families, and will help prevent poverty caused by illness, he said.

Statistics indicate that many cancer patients in China have been struggling to acquire cheap, quality medicine. According to the national cancer institute, the market for antineoplastic drugs in China exceeds 120 billion yuan ($19.1 billion). However, they are usually too expensive for working class families.

"We are speeding up in making high-quality generic drugs available in the market, but most of the targeted anticancer drugs were still imported," said Liu Lihong, a doctor at the Beijing Chaoyang Hospital. Another doctor at the hospital, Chen Wenming, said that despite social insurance, patients in Beijing still have to pay 20% of the total price of the drugs. The percentage is even higher in less developed areas.

For this, the State Council put forward a solution at the meeting, asking for the timely inclusion of imported new drugs in the range of medical insurance, especially urgent cancer drugs. In addition, the import procedures of new medicine will be streamlined, as importing enterprises will take charge of the examination of the drugs, instead of compulsory examination by authorities. "It will make it easier for patients to access the drugs in terms of timing," said Shi Luwen. "It also adds to the enterprises' responsibilities to ensure the quality and safety of the drugs, while saving their time."

As for the long term, experts are expecting higher capabilities of medical institutions on the grassroots level, and the balance of the share of drugs in different areas, so that urgent medicine including anticancer drugs can more efficiently and accurately benefit the people. "More measures will soon be implemented to make sure those in urgent need of medicine can get sufficient, quality and cheaper drugs in time," the National Health Commission said. (Source: Xinhua)

April: China pushes generics over brands with another round of new pharma policies

On April 3rd, the Chinese government issued a new policy package—including tax breaks—to promote generics. This would allow certain qualified generics makers to be designated as high-tech enterprises, a label that comes with a 15% corporate tax rate, compared to 25% for other companies. The policy also makes clear that China considers compulsory patent licensing a bona fide option during public health emergencies or shortages of key drugs.

The government's health department and recently rebranded drug regulator will compile and actively update a drug list that encourages companies to produce generic versions. That list will include medications for rare diseases, major infectious diseases and pediatric treatments, as well as important drugs that are running scarce.

Except in special circumstances, physicians will not be allowed to write brand names on prescriptions, and even if they do, pharmacists will have the right to change to qualified generics. The decree, issued by the country’s State Council, also says it intellectual property protections will be tweaked to “strike a balance between the interests of patent holders and the public,” and will strengthen anti-monopoly enforcement.

China’s patent infringement situation has been under fire from countries like the U.S., and it’s one of the reasons cited by the Trump administration as justification for its recently proposed $50 billion tariff against China. In its 2016 Top Markets Report, the International Trade Administration under the U.S. Department of Commerce noted that in China, a company cannot bring a patent infringement case against a violator until the disputed product is launched on the market. Injunctions are rarely granted in pharma patent cases, the report said, and damages awarded are usually too low to cover lost revenue.

China has been relying largely on generics. Of about 170,000 drug approvals issued by the China FDA, over 95% are generics, according to the country’s National Health Commission. But many generics in China are poorly made and much less effective than their originals. To eliminate those low-cost, low-quality copycats, CFDA is in the process of a generics bioequivalence evaluation campaign.

Under this newly released set of guidelines, the Chinese government is also pushing for broad use of generic names instead of branded names. Copycats that pass the quality equivalence test will be labeled with the same generic name as the brand in a procurement catalog hospitals use to purchase drugs. The generics will also be covered by national insurance under the same standards.

All of these policies will further compress the breathing room for innovative drugs—currently mostly produced by foreign pharmas—especially those that already have generics on the market. (Source: FiercePharma)

March: 50~60 million people suffer from sleep disorders in China

A China sleep medicine survey report and a 2018 China white paper on Internet users' sleep were published on March 17, just four days ahead of this year's World Sleep Day. According to these two reports, around 50-60 million people in China suffer from sleep disorders. The reports have attributed the results to heavy work pressure and the habits of using smart phones before bedtime.

The white paper shows that 56% of those surveyed believe they have sleeping problems, including dreaming a lot, having light sleep and feeling sleepy after getting out of bed in the morning. Young people are the most sleep deprived group, especially those who work in first-tier cities. Beijing youth are found to sleep the least, with less than seven hours daily on average.

With regards to the causes of sleeping problems, 70% of surveyed netizens say their sleep has been affected by stress from work. People working in the financial and service sectors, as well as government agencies have the poorest sleep quality, according to the white paper.

In addition, nearly 90% of Internet users have a habit of playing with their mobile phones before going to bed. Experts note that luminous screens, such as those on mobile phones and computers, can increase peoples' alertness and excitability, impacting the time of falling asleep.

Sleep disorders are a dangerous factor in causing dementia, while adequate sleep is helpful in protecting the brain, according to Ye Jingying, director of the Sleep Medicine Specialized Committee with Chinese Medical Doctor Association.

Only less than 2% of those with sleep disorders get proper medical treatment, and on average, there are only 5.8 hospital beds for every one million patients in China's developed regions, the survey says. "We are seeing a lack of medical capacity and professional staff," said Han Fang, chair of the Chinese Sleep Research Society. (Source: China Plus)

March: China to give more support to patients with rare diseases

China has launched a program aiming at helping patients with rare disease in diagnosis and treatment and offering financial support to those in need. "The cost of treatment and care throws a lot of families into poverty. But what is more desperate yet, is that people often simply don't know what took their loved one's life," said Wang Yiou, head of the Illness Challenge Foundation, who lives with brittle-bone disease. The program, which was launched Wednesday, will be sponsored by the Illness Challenge and China Social Assistance foundations. It will help with diagnosis and treatment of up to 100 diseases.

With its enormous population, disparate geography and socioeconomic inequalities, China faces considerable obstacles in improving care for patients. "Patients in remote areas like the northwest often suffer years of physical and mental torture and have to bear with misdiagnosis or delayed diagnosis before they know what's wrong," said Wang.

At present, Chinese patients with rare diseases have very few options in terms of treatment. "For most of them, there is no effective treatment and when there is, patients cannot afford it," said Wang.

China is still in the early stages of making policy on rare diseases. "Diagnosis and availability of drugs remain significant challenges," said Zhang Xue, a member of the committee for rare disease treatment and support with the National Health and Family Planning Commission.

Some progress in licensing drugs and increasing reimbursement has been made and the first national list of rare diseases will be published this year. According to the Medical Insurance Directory, China currently has 119 new drugs at various stages of licensing and registration, of which 49 are covered by national medical insurance. "The support program will bridge the gaps between individual patients, medical resources and insurance. We hope misdiagnosis and delayed diagnosis will become less frequent. Patients and their families deserve a good living and should know they are supported," said Wang.  (Source: Xinhua)

March: Chinese scientists develop DNA nanorobots to treat cancer

Chinese scientists said they have successfully created and tested the world's first autonomous DNA nanorobots to combat cancer tumors, paving the way for revolutionary cancer therapy.

Scientists from China's National Center for Nanoscience and Technology (NCNST) led the research and cooperated with scientists from Arizona State University in upgrading the design of the nanorobots. The scientific study was published in Nature Biotechnology in February.

A nanorobot refers to a designed system that can perform a specific task at nanoscale dimensions. According to researcher Ding Baoquan, the DNA-based nanorobot has a tube-shaped structure with a diameter of about 19 nanometers and a length of about 90 nanometers.

"The nanorobot is exceptionally small and impossible to see with naked eyes. It is about 5,000 times smaller than the tip of a needle," Ding said. It can travel through the bloodstream searching for tumors. Once it detects a tumor, it will release its load of thrombin directly into the tumor to cut off its blood supply and "starve" the tumor to death. As the DNA nanorobot is a natural biocompatible and biodegradable material, it is cleared out of the body after it has finished its task.

Nanotechnology has provided new opportunities for medical industry. The research was started five years ago, when NCNST researchers first looked at cutting off the tumor blood supply by using DNA-based nanocarriers. Ding said although the concept of nanorobots for medical use has previously been introduced and experiments conducted in test tubes, this is the first time that experiments have been completed on living organisms with sophisticated biological environments.

The research evaluated the nanorobots in mice with tumors. The DNA nanorobots were injected into mice, and the results showed significant tumor shrinkage and often, complete tumor regression, within days or weeks. According to scientist Zhao Yuliang, the research team also conducted extensive safety studies of the nanorobots in two different mammals, including the Bama miniature pig, which is physiologically and anatomically similar to humans.

"Unlike chemotherapy and radiation, the DNA nanorobots are able to treat tumors without harming surrounding healthy tissue. The nanorobots do not accumulate in the brain and thus, do not pose the risk of causing a stroke," Zhao said.

Nie Guangjun, also part of the research team, believes this is a milestone in cancer research, a field that has been striving for decades to develop effective therapies. "Our research shows that DNA-based nanocarriers have been shown to be an effective and safe cancer therapy," Nie said. "We are currently working with a biotech firm to do pre-clinical studies and hope to translate this revolutionary technology into a viable anti-tumor therapeutic," Nie added. (Source: Xinhua)

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