1、 Focus of this week — panorama of the development of innovative drugs at home and abroad in 2021
Bid farewell to 2021. Looking back, we can see that new drugs at home and abroad have achieved unprecedented development. In this year, the internal volume of PD-1 intensified, the clinical R & D policy of tumor drugs tightened, and the IPO of new shares broke frequently; At the same time, the commercialization of cell therapy has been realized, the international development of local pharmaceutical enterprises has continued to move forward, and domestic covid-19 specific drugs have gone abroad. China’s innovative drug industry has made breakthroughs in opportunities and challenges.
In this week’s weekly report, we comprehensively check the development of innovative drugs at home and abroad in 2021 with 24 charts from four dimensions: China’s new drug approval, overseas new drug progress, internationalization of local pharmaceutical enterprises, medical insurance negotiation and large-scale variety. The multi-dimensional situation has been broken, and China’s innovation achievements are brilliant. Innovation medicine has formed a general trend from homogenization to differentiation, from following innovation to source innovation. In 2021, China’s National Drug Administration (nmpa) approved at least 62 new drugs. In terms of molecular types, small molecule new drugs occupied an absolute advantage, and ADC and car-t were launched for the first time; From the perspective of targets, RET, met and PPAR have ushered in heavy harvest; In terms of disease field, anti-tumor fever is maintained, followed by anti infection and autoimmune diseases. Covid-19 epidemic promotes the vigorous development of relevant vaccines and specific drugs. The number of innovative drug applications for NDA and ind is rising, which reserves strength for China’s follow-up new drug research and development.
The proportion of pioneering therapies has increased, and the epidemic situation has reshaped the pattern of the global pharmaceutical market. In 2021, FDA approved a total of 50 new drugs, 2 cell therapies and 5 vaccines. First in class therapy accounted for half of the country and reached a new high in innovation; Urgently authorize a variety of neutralizing antibodies and oral small molecule drugs to deal with covid-19 epidemic. In the first three quarters, the total sales of the world’s top 10 best-selling drugs increased significantly by more than 50% year-on-year. Pfizer covid-19 mRNA vaccine comirnaty took over the “drug king” Humira, with us $24.277 billion, writing a new record of drug sales. “Bringing in + going out”, domestic innovation has reached the turning point of internationalization. Under the background of market space compression caused by China’s policy influence, Chinese pharmaceutical enterprises with strong R & D strength actively layout international development. Domestic innovative drugs seek overseas listing, seek a broader international market and establish local R & D brands; The license out reflects the establishment of China’s innovative medicine ecology, and the license in shortens the technical gap with other mainstream pharmaceutical markets. The endogenous cycle between domestic R & D achievements has promoted the long-term development of local innovation. Health care negotiations are in full swing to help accelerate the volume of innovative products. The dynamic adjustment mechanism of “cage for bird” in the medical insurance catalogue helps to optimize the drug structure, the negotiation form greatly speeds up the integration of innovative drugs into medical insurance, and catalyzes the rapid and large-scale production of domestic innovative drugs. In 2020, 79 kinds of Western medicines newly added to the medical insurance catalogue are spreading smoothly and in considerable quantities; In 2021, 74 new products will be added, and China’s innovative drug market will continue to prosper.
2、 Review of innovative drug stocks in the pharmaceutical sector:
This week Beijing Kawin Technology Share-Holding Co.Ltd(688687) , Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) , Shanghai Junshi Biosciences Co.Ltd(688180) – u, Chengdu Kanghong Pharmaceutical Group Co.Ltd(002773) , Frontier Biotechnologies Inc(688221) – U ranked the top 5 in the rise and fall of Shanghai and Shenzhen pharmaceutical innovative drugs. The last 5 are Staidson(Beijing) Biopharmaceuticals Co.Ltd(300204) , Jenkem Technology Co.Ltd(688356) , Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Hunan Nucien Pharmaceutical Co.Ltd(688189) , Livzon Pharmaceutical Group Inc(000513) .
This week, the top 5 gainers and losers in the pharmaceutical innovation sector of Hong Kong stocks were Shanghai Junshi Biosciences Co.Ltd(688180) , Rongchang biology-b, Geli pharmaceutical-b, jiakesi-b and Yasheng pharmaceutical-b. The last five are tengshengbo medicine-b, Yaoming junuo-b, Jiahe biology-b, heplatinum medicine-b and Xiansheng pharmaceutical.
3、 IPO this week: Chengda pharmaceutical, a cdmo supplier with increasing industry competitiveness;
4、 Medium and long term perspective of innovative pharmaceutical industry:
In recent years, with the influx of capital stimulated by policies, China has ushered in a gale of innovation. China’s innovation market has strong policy attributes. On October 8, 2017, the two offices jointly issued the opinions on deepening the reform of review and approval system and encouraging innovation of drugs and medical devices, which opened the first wave of innovation. With the revision of drug registration management measures, drug negotiation and the introduction of medical insurance dynamic adjustment mechanism, the top-level design of the policy has completely solved the problem of insufficient innovation power in history due to limited R & D resources, non-standard Review & slow progress, low bidding efficiency, high difficulty in admission and difficult connection of medical insurance. Under the stimulation of Programmatic Policies, combined with the promotion of the science and innovation board and the registration system in recent years, the capital of innovative medicine racetrack swarmed, and the financing of innovative medicine enterprises accelerated, which also led China’s innovative medicine investment into the gale mouth era. Driven by a good policy environment and capital, China’s innovation rise has accelerated. Domestic innovative drugs have entered the harvest period one after another, and more heavy innovative products will be approved and listed in China in the next few years.
It can not be ignored that the time window for “general innovation” given by the policy is becoming shorter and shorter, the cost control of medical insurance is becoming stricter, and the track is becoming more and more crowded. We have slowly entered the moment of “selected high-quality innovation”. At present, the homogenization of innovative drug research and development in China is more serious, and the homogenization of targeted drugs is the most serious. The era of “blockbuster” when innovative drugs are listed has slowly passed, and the time window period of “general innovation” given by the policy is becoming shorter and shorter. We believe that China’s innovative drug market has slowly entered the moment of “selected high-quality innovation” from “general innovation”. In the future, the homogenization competition of McAb hot targets will continue to be intense, and the homogenized products will gradually lose their competitiveness. New technologies, scarce technology platforms, differentiated treatment fields and innovative drug delivery methods may bring a better competitive pattern to enterprises, and companies with technology precipitation are expected to stand out.
Risk tips: 1) negative policies continue to exceed expectations; 2) The growth rate of the industry was lower than expected.
