I. Insight about the industry
Recently, there is a saying in the pharmaceutical industry: not all innovative drugs have a future. This saying reminds me of the lyrics - wild lilies also have spring. To be honest, the high failure rate in the field of innovative drugs make all practitioners and investors prepare for failure very early.
Is such a high failure rate daunting? We are delighted to see that the efforts and hardships of the past decade have prepared the teams involved in Chinese innovative drug industry, whether developers, investors or regulators, for this situation. Many projects have been successful, and some are on the road to success.
II. Analysis on the overall situation of Chinese pharmaceuticals industry
On October 8, 2021, Evive Biotech, a subsidiary of Yifan Pharmaceutical Co., Ltd., announced that the European Medicines Agency (EMA) had officially accepted the Marketing Authorization Application (MAA) of Evive Biotech on Ryzneuta™ for treating neutropenia (CIN) caused by chemotherapy, and centralized review procedure has begun. This is another good news after Evive Biotech submitted Ryzneuta™ (known as F-627) Biologics License Application (BLA) to FDA in early 2021.
For a long time, the status of pharmaceutical research and development in China has been worrying, mainly reflected in the insufficient investment in R&D funds of enterprises. At the same time, there is a waste of R&D resources and low efficiency in some areas. Pharmaceutical R&D projects are homogenous with intense competition from same target development, which can be described as full of involution. There is a lack of innovation or high level of innovation for pharmaceutical enterprises. In recent years, the pharmaceutical market in China has become more mature and perfect. With the adjustment and influence of policies such as new drug evaluation system, generic drug consistency evaluation, volume-based purchasing, adjunctive medication monitoring and upgrading of health insurance directory, the examination and approval of new drugs is gradually accelerated. The development momentum of innovative drugs in China has been significantly improved, the innovative achievements of some biopharmaceutical companies have been constantly revealed, and the vitality of innovative drugs has been constantly released. The innovative drugs from China are creating history and going abroad. On the other hand, the cooperation between Chinese and foreign pharmaceutical companies and R&D institutions is becoming more frequent. An increasing number of pharmaceutical companies and medical supplies manufacturers choose report their results in both China and the US or China and the Europe. In this way, some projects can not only advance the layout of domestic and international markets, but also make full use of foreign intellectual support and review experience to promote the optimization of domestic review process.
III. Policy support and achievements in China
In 2015, the State Council issued the Advice about Reforming Drugs and Medical Devices Appraisal and Accreditation System. In February 2016, the China Food and Drug Administration issued the Advice about Resolving the Backlog of Drug Registration Applications and Implementing Priority Review and Approval. In 2017, the General Office of the CPC Central Committee and the General Office of the State Council issued the Advice about Deepening the Reform of Examination and Approval System to Encourage the Innovation of Drugs and Medical Devices. The above reform of drug review and approval system and the gradual establishment of a sound drug priority review and approval system have promoted the development of drug innovation.
In 2016, the General Office of the State Council issued the Pilot Program of Drug Marketing Permit Holder System, which is of great significance for encouraging drug innovation and improving drug quality.
In 2018, National Healthcare Security Administration included 17 anti-cancer drugs in Class B of the National Basic Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug List, paving the way for innovative drugs to be included in the health insurance directory through negotiation.
In 2019, the newly revised Drug Admi...
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