Review of new drug market this week: from February 28, 2022 to March 4, 2022, the top 5 enterprises in the new drug sector: Guangdong Zhongsheng Pharmaceutical Co.Ltd(002317) (+ 13.5%), Cornell (+ 8.0%), Connaught (+ 7.7%), Geli Pharmaceutical (+ 4.5%) and Shanghai Junshi Biosciences Co.Ltd(688180) (+ 3.7%); The top 5 enterprises with decline: Tianyan Pharmaceutical (- 27.8%), zaiding Pharmaceutical (- 23.8%), jiakesi (- 17.9%), Hehuang Pharmaceutical (- 16.4%), Genxi biological (- 15.9%)
Key analysis of new drug industry this week:
This week, Shanghai Junshi Biosciences Co.Ltd(688180) adalimumab biological analogues (for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis), Jiahe biological infliximab biological analogues (for improving inflammatory response and autoimmune diseases) were approved for marketing. In addition, Fuhong Hanlin rituximab biological analogues were approved for new indications (for rheumatoid arthritis). Since 2021, the Chinese market has ushered in the intensive listing of biological analogues. Several heavy varieties of biological analogues such as bevacizumab, adalimumab and trastuzumab have been listed in China. The competition in the whole industry is becoming increasingly fierce. Among them, a number of biological analogues have met the conditions for centralized purchase. It is expected to usher in centralized purchase this year and next, accelerating the change of industry pattern. Take bevacizumab as an example: at present, one original research (Roche) and eight biological analogues have been approved for marketing in China, and another biological analogues are in the stage of market review. Many approved manufacturers have met the quantity required for centralized procurement. According to the data of sample hospitals, the sales of bevacizumab and its biological analogues in sample hospitals in China reached 1.86 billion in the first three quarters of 2021, and it is expected to reach 2.48 billion in the whole year; Given a sales multiple of 2.5 times, it is estimated that the market scale of bevacizumab and its biological analogues in China will reach 6.2 billion yuan in 2021. Referring to the situation after the centralized collection of other varieties, we predict that the market scale of bevacizumab biological similar drugs may shrink to 3 billion yuan. Roche and Qilu pharmaceutical, which currently account for the main share, are expected to suffer from the centralized collection policy, while other manufacturers such as Jiangsu Hengrui Medicine Co.Ltd(600276) , Cinda biology, etc. are expected to benefit from the centralized collection. In addition, biological similar drugs such as adalimumab, rituximab, trastuzumab, desuzumab and infliximab are likely to be intensively purchased this year and next, and the industry pattern of listed varieties is expected to accelerate change.
Approval & acceptance of new drugs this week:
This week, 5 new drugs or new indications of new drugs were approved for listing in China, 23 new drugs were approved ind, 19 new drugs ind and 4 new drugs NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) in March 2nd, Chongqing Zhifei Biological Products Co.Ltd(300122) announced that China’s State Drug Administration has approved the registration of recombinant New Coronavirus protein vaccine (CHO cells) of its subsidiary, Chi Fei Long Ma, with its approval. According to the announcement, the vaccine is the first approved China’s recombinant COVID-19 virus protein vaccine, which is suitable for preventing New Coronavirus infection caused diseases (COVID-19).
(2) on March 3, Keji pharmaceutical announced that its self-developed car-t cell candidate product ct041 was approved by the drug evaluation center of the State Drug Administration of China to enter the confirmatory phase 2 clinical trial, which is mainly used for claudin18 who has failed to receive at least second-line treatment in the past 2 positive expression in advanced gastric cancer / esophageal gastric junction adenocarcinoma (GC / GEJ).
(3) on March 2, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) announced that its CD19 target autologous car-t cell therapy product fkc889 was used in adult patients with recurrent or refractory mantle cell lymphoma (R / rmcl) after receiving second-line or above treatment, and was approved by nmpa to carry out clinical trials.
Top 3 of overseas new drug industry this week focuses on:
(1) on March 1, Bristol Myers Squibb announced that FDA approved opdivo (nivolumab), a blockbuster PD-1 inhibitor, combined with platinum containing dual drug chemotherapy as a neoadjuvant therapy for patients with resectable non-small cell lung cancer (NSCLC), regardless of the expression of PD-L1. This is the first immunotherapy combination approved for the treatment of non-small cell lung cancer before surgery.
(2) on March 3, AstraZeneca and Sanofi jointly announced that the phase 3 clinical trial of antibody nirsevimab under development had achieved positive results and reached the main efficacy endpoint. A single dose of nirsevimab reduced the incidence of lower respiratory tract infections in infants requiring treatment caused by respiratory syncytial virus (RSV) by 74.5% compared with placebo. At the same time, this is the first passive immunotherapy for all infants that can provide continuous immune protection throughout the RSV season with a single vaccination.
(3) on March 1, the bcmacar-t product cilta cel, developed by Johnson & Johnson’s Janssen and legendary biology, has been approved by the FDA for the treatment of adult patients with recurrent / refractory multiple myeloma, which is also the second car-t therapy targeting BCMA approved by the FDA. Previously, sidakiolensea has obtained the orphan drug qualification, breakthrough therapy recognition and priority review qualification granted by FDA, and has been included in breakthrough therapy varieties in China.
Risk warning: the risk that the progress of clinical trials is less than expected, the risk that the results of clinical trials are less than expected, and the risk of changes in medical policies.
