R & D side: innovative drugs have entered the harvest period, but homogeneous R & D is more serious. The R & D of innovative drugs has entered the harvest period, and the number of ind and approved listing reached a new high. With the continuous improvement of innovation and R & D Quality in China, heavy varieties of licenseout appear frequently. At the same time, the research and development has achieved initial results, and a number of domestic innovative drugs have been approved by FDA.
From the perspective of increasing R & D investment and innovation, the enthusiasm of enterprises continues to rise. However, there are many problems of homogeneous research and development of innovative drugs in China, resulting in excessive fierce market competition.
Sales side: the revenue of innovative drugs is growing rapidly, but the medium and short-term competition is fierce. As the number of innovative drugs approved for listing in China increases, the sales revenue of innovative drugs continues to increase, and some enterprises have entered the harvest period. Medical insurance negotiation helps accelerate the sales of innovative drugs, but under the dual pressure of medical insurance fee control and fierce competition in the drug market, the price reduction range is relatively large, and the overall market competition is fierce. With the listing of core products, some biotechs have been in transition, and the commercialization ability has become the core competitive point. In terms of drug types, due to the differences between China's payment ability and mode and the European and American markets, gene / cell therapy, which has been highly praised in recent years, is still a minority drug in China in the short and medium term.
Policy side: regulators have increased requirements for drug innovation and effectiveness, and it is more difficult to develop drugs. From the perspective of China, the clinical guiding principles have been issued, the R & D of me too drugs has been blocked, and the R & D difficulty and risk of innovative drugs have increased. In addition, the pharmaceutical industry in the 14th five year plan has been standardized to promote innovation driven transformation. At the overseas end, FDA has strict requirements for international multi center clinical practice, and the export route of domestic innovative drugs is blocked and long.
Investment side: the coldness of the secondary market leads to the reduction of the heat of the primary market. The biomedical index in the secondary market continued to decline and the market sentiment was weak. Moreover, the IPO Financing of Hong Kong stocks is gradually cold, and the innovative pharmaceutical enterprises in a + H shares break frequently.
In addition, the risk of "pre delisting" of US stocks has further increased the volatility of the secondary market. The sentiment of the secondary market is also gradually transmitted to the primary market, resulting in a decline in the growth rate of innovative drug investment, and the short-term market is still on the sidelines.
Payment side: the pressure of short-term medical insurance payment leads to the pressure on the innovative drug market. As the core payment method of China's medical care, medical insurance will not change in the short term. The aging population increases the pressure on medical insurance payment. Moreover, with the national attention to traditional Chinese medicine and the impact of epidemic prevention, the pressure on medical insurance funds continues to increase. In the short term, great progress has not been made in innovative payment methods. Relying solely on medical insurance payment leads to pressure on the innovative drug market.
Industry trends. In the short term, the industry has entered a period of adjustment. The R & D targets of Chinese innovative drug enterprises have moved forward, and the exploration of new technologies has increased. Under the requirements of strengthened regulatory policies, the R & D cycle and risk have increased. At the same time, the fluctuation of the secondary market has reduced the heat of the primary market and increased the difficulty of financing. For some biotech enterprises that have no products on the market or are not profitable, they need to pay attention to the cash flow situation. If there is a problem with the cash flow of the enterprise, it may accelerate the trend of M & A in the industry. In addition, biotech enterprises that have listed their products may also be differentiated due to their commercialization ability. In the future, the commercialization cooperation among Chinese pharmaceutical enterprises may be more frequent.
Banking. (this paragraph is deleted. If China Merchants Bank Co.Ltd(600036) departments need the original report, please contact China Merchants Bank Co.Ltd(600036) Research Institute with the contact information at the end of the text).
Risk warning. The R & D Progress of innovative drugs is less than expected; The sales of innovative drugs were less than expected; The regulatory policy was further tightened and the clinical speed slowed down; Poor capital market environment and tight cash flow of enterprises; The delisting risk of "zhonggai shares" in US stocks exceeded expectations.
