Trend of A-share and Hong Kong stock innovative medicine plate this week
In the second week of December 2021, a total of 18 stocks in the mainland and Hong Kong innovative drug sector rose and 23 stocks fell. Among them, Shanghai Junshi Biosciences Co.Ltd(688180) - U (+ 11.83%), Fuhong hanlin-b (+ 9.04%), Hansen Pharmaceutical (+ 8.79%), Baiji Shenzhou (- 13.98%), Shanghai Allist Pharmaceuticals Co.Ltd(688578) - U (- 13.56%) and Corning Jerry pharmaceutical-b were the top three (- 8.5%). This week, the A-share innovative drug sector rose 3.61%, outperforming the CSI 300 index by 0.47pp, and the biomedicine sector rose 0.65%. In the past six months, the A-share innovative drug sector fell 23.65%, underperformed the CSI 300 index by 20.39pp, and the biomedicine sector fell 21.79%. This week, the Hong Kong stock innovative drug sector fell 0.99%, underperformed the Hang Seng Index by 1.95pp, and the Hang Seng healthcare sector fell 0.05%. In the past six months, Hong Kong Shares of innovative drugs fell 35.2%, underperforming the Hang Seng Index by 17.41pp, and Hang Seng healthcare fell 41.15%.
Progress of key innovative drugs in China
In December, two new drugs were approved for marketing in China. This week, one new drug was approved for the first time, and two innovative drugs were approved for new indications. NMPA approved Tengsheng pill's BRII-196 and roomsway monoclonal antibody injection (BRII-198) for New Coronavirus infection. Jiangsu Hengrui Medicine Co.Ltd(600276) Two new indications were approved for the PD-1 inhibitor carrelizumab, namely, the first-line treatment of advanced esophageal cancer combined with paclitaxel and cisplatin, and the first-line treatment of advanced or metastatic squamous non-small cell lung cancer (NSCLC) combined with chemotherapy. Haisco Pharmaceutical Group Co.Ltd(002653) cyclophenol injection was approved as a new indication for sedation and / or anesthesia in bronchoscopic diagnosis and treatment.
Progress of overseas key innovative drugs
In December, a new drug was approved by FDA. A new drug was approved this week. Clindamycin phosphate of Darey bioscience was approved for marketing on December 7 for the treatment of bacterial vaginosis. In December, two new drugs were approved for marketing in Europe. In December, four new drugs were approved for marketing in Europe. Four new drugs were approved this week. Cyproterone acetate + ethinylestradiol, ethinylestradiol + pregnenone and dinogestrin + ethinylestradiol of Bayer healthcare company are used to treat contraception, acne and polycystic ovary syndrome. Horse anti human thymocyte immunoglobulin of Pfizer pharmaceutical company is used to treat aplastic anemia and renal transplantation rejection.
Excellent clinical results published this week
The important clinical trial results published this week include: 1) tirelizumab of Baiji Shenzhou published the clinical data of combined chemotherapy for first-line treatment of nasopharyngeal carcinoma, adjuvant treatment of esophageal cancer and treatment of non squamous non-small cell lung cancer with EGFR mutation treated by TKI. The results of the latter two groups of clinical data are better in similar varieties and deserve attention. 2) The phase III clinical results of Merck's pabolizumab combined with renvatinib in the treatment of non-small cell lung cancer showed that MPFs: 6.6 vs 4.2 months, Orr: 40.5% vs 27.7%, and the overall evaluation was positive. 3) Benvemod of Tianji pharmaceutical was used to treat plaque psoriasis. According to the phase III clinical results of different experimental groups, the results of 510 people group were PGA 0 / 1: 35.4% vs 6.0%, and that of 515 people group was pga0 / 1: 40.2% vs 6.3%. The overall evaluation was positive. 4) The phase II clinical results of Jiangsu Hengrui Medicine Co.Ltd(600276) carrelizumab in the adjuvant treatment of esophageal squamous cell carcinoma showed that PCR: 35%, and the overall evaluation was positive. 5) The phase II clinical results of Shanghai Junshi Biosciences Co.Ltd(688180) treprizumab combined with chemotherapy in the adjuvant treatment of non-small cell lung cancer showed that PCR: 36.8%, and the overall evaluation was positive. 6) Daiichi Sankyo worked with AstraZeneca in the development of two drugs: trastuzumab deruxtecan for the treatment of HER2 positive breast cancer and cancer brain metastasis II phase clinical results showed that CNS ORR: 55.6% reached the main purpose of the trial, the overall evaluation was positive; Datopotamabderuxtecan's phase I clinical results for three negative breast cancer showed that ORR: 34%, DCR:77%, overall evaluation was positive.
Progress of global key innovative drug transactions this week
This week, there were 11 key transactions in the world, and there were 4 key transactions with disclosed amount. 1) Roche and AI pharmaceutical company recursion announced a cooperation to develop the field of neuroscience and cancer. Recursion will receive an advance payment of US $150 million and be eligible for additional milestone payments. 2) Ionis pharmaceutical announced a strategic cooperation agreement with AstraZeneca to jointly develop and commercialize the antisense therapy drug eplontersen. Ionis will receive $200 million in advance, up to $485 million in development and approval milestones, up to $2.9 billion in sales related milestone payments, and a low double-digit to about 20% commission. 3) Aerie signs rhopressa with Santen ® And rocklatan ® Exclusive licensing agreements in Europe and several other regions focus on the development of drugs in the field of glaucoma and ocular hypertension. Aerie will receive an advance payment of $88 million and various development, regulatory and sales milestones of up to $77 million. 4) Langyu group and rhythm announced that they had reached an exclusive license agreement to jointly develop and commercialize imcivree, a rare genetic obesity treatment drug, in China. The down payment was US $07 million, the milestone payment was US $63.5 million, and the total transaction amount was US $75.5 million.
Weekly small topic - hepatitis B functional cure: China has added nearly one million people every year to hepatitis B, with about about 20000000 people in stock, and more than 50 million people are estimated to have hepatitis B virus carriers. Nucleoside analogues and interferon commonly used in clinic can control HBV DNA at a low level, But serum HBsAg could not be cleared Hepatitis B surface antigen. Functional cure of hepatitis B means continuous and detects of serum HBsAg and HBV-DNA, which can be discontinued by continuous functional cure. The follow-up progress of disease is different from that of ordinary people. Therefore, functional cure of hepatitis B is of great importance. At present, all companies outside China have actively developed new drugs to achieve functional cure of hepatitis B. The mechanism of action includes antisense therapy, anti-pdl1 single domain antibody, FXR agonist, RNAi therapy, etc., and some companies are exploring the combination of multiple mechanisms, which is expected to achieve better results. China's leading companies include gelly Pharmaceutical (evolizumab, phase II) and tengshengbo Pharmaceutical (vir-2218, phase II).
Risk warning: expected risk of drug price reduction; The implementation progress of medical reform policy is lower than the expected risk; Risk of R & D failure.
