时间：2022-05-08 05:18:15
When multinational drug makers deal in China， the value of patience might come second only to guanxi - connections.
A new foreign drug can only be approved for retail in China three to four years after hitting shelves in the US or Europe due to rigid regulations and a drawn-out review process， according to a survey by IMS Health， a medical consultancy based in Shanghai.
China is one of few countries that require new foreign medicines to be tested according to local standards through domestic clinical trials. Typically， only drugs that have been marketed overseas or those that have passed primary clinical trials are approved for testing in China. Of course， there are always exceptions.
Novartis has become the first foreign pharmaceutical company to have one of its products approved for early-stage clinical trials by China’s State Food and Drug Administration （SFDA）. The treatment in question， a lung cancer drug， is expected to be the first new foreign drug to hit the Chinese market at the same time as other world markets， according to a May report by the China Business News.
This change comes at the same time as the SFDA has renewed efforts to streamline China’s new drug review process. In early March the SFDA stated in a guideline that， during the review process， priority would be given to new drugs that could address an unmet need or could promote market competition and thus lower prices for similar drugs on the Chinese market.
However， this change is unlikely to have been made with the interests of Chinese patients in mind. According to reports， the SFDA had already decided to speed up the review process mainly because a State program of innovation in domestic pharmaceutical development drug innovation is beginning to bear fruit， according to Chen Changxiong， deputy secretary general of China Pharmaceutical Industry Research and Development Association.
Underdeveloped
China has set itself ambitious goals in pharmaceutical innovation targets rolled out in 2005， which demand that pharmacologists deliver 100 new medicines or medical treatments for the country’s most pressing health problems particularly cancer， diabetes and cardiovascular diseases - by 2020.
The program also set a target to transition China from a generic drug manufacturer to major leader in pharmaceutical R&D， specifically， to earn the country a place in the world’s top three by 2020.
Currently， however， China is struggling to get new drugs onto the market， thanks to a bloated and bureaucratic approval system as well as a guanxi-centric network of healthcare providers.
“To realize [the transition of the] Chinese pharmaceutical industry from imitator to creator depends upon the elimination of innovation bottlenecks，” said Alex Zuo， a spokesman for the R&D-based Pharmaceutical Association Committee （RDPAC）， a non-profit organization representing 39 member multinational pharmaceutical producers in China under the China Association of Enterprises with Foreign Investment.
It takes 10 to 18 months for a new drug simply to get the go-ahead from the SFDA to start clinical trials， in contrast to about one month in the US and two in the EU.
The lengthy approval procedure disincentivizes drug innovation because it shortens the time left within the 20-year patent protection period for new drugs， a period vital for drug makers to recoup often immense R&D costs and actually turn a profit. According to Zuo， some domestic pharmaceutical enterprises even resort to clinical trials in other countries just to speed up the process.
So far， China’s pharmaceutical industry has a low market concentration and weak R&D capabilities， particularly compared to India and other large developing economies. Almost all of more than 3，000 chemical medicines manufactured in China since the 1950s are imitations of foreign products， as are more than 90 percent of China’s domestically manufactured biopharmaceuticals.
“Regulations have been improved over past two decades， yet one still finds vestiges of this generic background，” Chloe Liu， managing partner of Modular R&D， an industry consultancy based in Shanghai， remarked in a research paper.
“The Chinese drug approval system was developed in the context of a large generic manufacturing industry，” she continued. “In the beginning， the drug regulator was faced with ensuring the production quality of thousands of small manufacturing facilities， instead of safety and efficacy concerns surrounding innovative new drugs.”
Understaffed
Besides a strong copycat tradition， a feature of many Chinese manufacturing enterprises， the new drug approval procedure is also hampered by a lack of personnel in regulatory agencies.
The Chinese Center for Drug Evaluation， the department of the SFDA in charge of approving clinical trials for new drugs， has only about 120 personnel screening over 6，000 applications per year， in contrast to some 3，300 working for the US FDA， which deals with far fewer applications.
“The State Council sets employment quotas at the SFDA， so hiring more people is not that simple，” said Liu.
This inefficiency has kept some life-saving drugs outside of China， at great cost to the country’s healthcare system. For instance， the HPV vaccine， which could prevent 70 percent of cervical cancer cases and has been included as a fundamental part of all healthcare provision in many countries since it was first marketed in 2006， remains unavailable in China.
About 15 percent of Chinese women are infected with HPV， and 75，000 of them are diagnosed with cervical cancer each year.
Apart from insisting on the factoring-in of racial differentials， an area of controversy in the medical field， China’s drug regulator requires additional localized clinical testing in part because the results of clinical trials conducted by domestic pharmaceutical companies struggle to be recognized overseas. This tit-for-tat approach to management is common in Chinese industry， but is particularly problematic in the pharmaceutical sector.
China is now the world’s fastest-growing pharmaceuticals market， with total predicted revenue of 1 trillion yuan （US$162.5bn） this year， and is expected to grow about 12 percent annually， doubling in size by 2019 due to a combination of extended coverage and an ageing population， according to a research report by the China Academy of Social Sciences.
While desperate for an inroad in the China market， foreign drug makers are confronted with far broader challenges than excessive bureaucracy. A major concern for international companies wishing to introduce new drugs into China is data leakage， given that the SFDA requires extremely detailed data prior to even beginning the review process， according to Chen.
“One thing that the SFDA could do is strengthen its protection of data submitted by drug manufacturers，” said Zuo of the RDPAC.
In 2012， only a year after Tygacil was approved by the SFDA， two Chinese copycats were greenlit by the SFDA， one of which was funded by the State drug innovation program. Tygacil is a super-antibiotic used to treat antibiotic-resistant bacteria and manufactured by Pfizer， which was marketed in the US in 2005 and Europe in 2006， with a patent that does not expire until 2016. The Chinese copycats of Tygacil are about 20 percent cheaper than the original， and there is little Pfizer can do to get them taken off the market.
With cheap local copycat drugs being approved faster than legitimate imported ones， it’s little wonder that global pharmaceutical giants are reluctant to become entangled in China’s chaotic market.