Review of new drug market this week: from May 16, 2022 to May 21, 2022, the top 5 enterprises in the new drug sector: zaiding Pharmaceutical (32.8%), Yasheng Pharmaceutical (32.4%), Yunding Xinyao (26.0%), Xinda Biology (22.0%) and kangnaide (21.3%). .
Key analysis of the new drug industry this week: this week, the results of a prospective cohort study of Shanghai Junshi Biosciences Co.Ltd(688180) covid-19 oral drug vv116 against the SARS cov2omicron variant were released.
In terms of curative effect: the preliminary clinical results showed that the patients treated with vv116 within 5 days after the first positive nucleic acid test had a shorter negative time than the patients in the control group (8.56 days vs 11.13 days); The time from the first medication to negative conversion in patients treated with vv116 was 3.52 days.
API demand: vv116 is one of the fastest-growing covid-19 oral drugs in China. If the clinical data of key phase 3 are good in the future, it is expected to be applied on a large scale in China. It is expected that there will be a large demand for API quantity. With reference to the clinical usage of vv116 in phase 3 of moderate and severe diseases, it is expected that 100 million courses of treatment will correspond to 360 tons of API.
Compound synthesis and upstream industry chain: as a new chemical structure molecule, vv116 has a long synthesis route and introduces deuterium atoms into the molecular structure, so the synthesis is relatively complex. We expect that after the product is approved for listing in China, there will be a huge demand for upstream APIs and intermediates.
Approval & acceptance of new drugs this week: this week, 2 new drugs or indications of new drugs were approved for listing in China, 15 new drugs were approved ind, 9 new drugs ind and 1 new drug NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) on May 18, Hansen pharmaceutical announced the phase 3 clinical results of ametinib versus gefitinib in the first-line treatment of locally advanced or metastatic non-small cell lung cancer with EGFR sensitive mutation. Compared with gefitinib, the PFS and continuous remission time of ametinib treatment group were significantly prolonged.
(2) on May 17, the phase 3 clinical trial of cornerstone pharmaceutical shuglizumab as consolidation treatment for stage III non-small cell lung cancer showed that shuglizumab further improved the PFS assessed by the blind independent center review (BICR), and the difference was statistically significant and clinically significant.
(3) on May 17, the clinical trial application of 3CL protease inhibitor sim0417 of Xiansheng pharmaceutical was approved by nmpa for post exposure prevention and treatment of close contact people who had been exposed to covid-19 positive infected persons.
Top 3 of overseas new drug industry this week focuses on:
(1) on May 19, the soluble guanylate cyclase stimulant vilixiapine jointly developed by Bayer / MSD was approved for marketing through nmpa priority review. It is suitable for adult patients with symptomatic chronic heart failure with recent decreased ejection fraction (ejection fraction 45%).
(2) on May 16, nykode therapeutics therapeutic cancer vaccine vb10 16 combined with PD-L1 inhibitor atezolizumab, positive results were obtained in phase 2 clinical trials in patients with HPV16 positive advanced cervical cancer.
(3) on May 20, rocketpharmaceutical was developing gene therapy. Rp-l201 obtained positive top line results in the key phase 2 clinical trial for the treatment of severe type I leukocyte adhesion defect (LAD-I). The estimated overall survival rate of patients treated with rp-l201 after one year was 100%.
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.
