Review of new drug market this week: from January 17, 2022 to January 21, 2022, the top 5 enterprises in the new drug sector: Geli Pharmaceutical (+ 18.5%), Fuhong Hanlin (+ 11.5%), Yongtai Biology (+ 9.6%), Shiyao group (+ 2.8%), zaiding Pharmaceutical (+ 1.5%); The top 5 enterprises with decline: Tianjing biological (- 17.8%), Keji Pharmaceutical (- 13.8%), Yunding Xinyao (- 13.5%), Rongchang biological (- 11.4%) and Deqi Pharmaceutical (- 11.4%).
Key analysis of the new drug industry this week: on January 20, the Geneva pharmaceutical patent pool (MPP) announced that it had signed agreements with 27 generic pharmaceutical enterprises (including 5 Chinese enterprises such as Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Langhua pharmaceutical, Longze pharmaceutical, Brightgene Bio-Medical Technology Co.Ltd(688166) , and Desano pharmaceutical) to produce molnupiravir, an oral covid-19 antiviral drug, and supply it to 105 low-income and middle-income countries. This agreement is the result of the license agreement reached between MPP and MSD in October 2021. The purpose is to promote patients around the world to use covid-19 oral drug jointly developed by MSD / Ridgeback at an acceptable burden.
This non exclusive sublicense agreement allows generic drug manufacturers to produce molnupiravir APIs and / or preparations. Among the 27 enterprises that signed the agreement, 5 enterprises will focus on the production of APIs (including Langhua pharmaceutical), 13 companies will simultaneously produce APIs and preparations (including Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Longze pharmaceutical, Brightgene Bio-Medical Technology Co.Ltd(688166) , Desano pharmaceutical), and 9 companies will produce preparations.
In addition, on November 16, 2021, Pfizer and the drug patent pool (MPP) announced the signing of a voluntary license agreement for Pfizer covid-19 pneumonia (covid-19) oral antiviral treatment candidate pf-07321332, which is used in combination with low-dose ritonavir. According to the terms of the general license agreement between Pfizer and MPP, qualified generic drug manufacturers with sublicenses worldwide will be able to supply the combination of pf-07321332 and ritonavir to 95 countries, covering up to 53% of the world’s population.
In China, the development of small molecule covid-19 drugs is also rising, including small molecule covid-19 drugs developed by real organisms, Shanghai Junshi Biosciences Co.Ltd(688180) / Wangshan wangshui / Chinese Academy of Sciences, Frontier Biotechnologies Inc(688221) and other enterprises have entered the clinical development stage, and at least seven small molecule covid-19 drugs are also in the preclinical development stage.
Approval & acceptance of new drugs this week: this week, 1 new drug or new indication of new drugs was approved for listing, 29 new drugs were approved for ind, 31 new drugs for ind and 4 new drugs for NDA in China.
Top 3 of China’s new drug industry this week focuses on:
(1) on January 20, the official website of the medicine patent pool (MPP) released a news that 27 generic drug companies had signed a license agreement with MPP and were approved to produce molnupiravir generic drug of cosadon covid-19 antiviral drug for 105 low to middle-income countries, including 5 Chinese companies: Brightgene Bio-Medical Technology Co.Ltd(688166) , Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) , Langhua pharmaceutical, Longze pharmaceutical Desano medicine. (2) On January 19, CDE’s official website showed that the application for listing of Jiangsu Hengrui Medicine Co.Ltd(600276) PD-L1 monoclonal antibody (adebailimab) was accepted. This is the fifth domestic PD-L1 monoclonal antibody applied for listing, which is used to treat extensive small cell lung cancer. (3) On January 18, goli pharmaceutical announced its cooperation with phokam Pharmaceutical Import Export Co. of Laos, Ltd (the buyer) signed the purchase agreement of ritonavir tablets. Ritonavir oral tablets are pharmacokinetic enhancers of a variety of oral antiviral drugs against viral protease.
Top 3 of overseas new drug industry this week focuses on:
(1) on January 19, leaptherapeutics announced that PD-1 antibody tirelizumab + DKK1 antibody dkn-01 combined with phase II clinical distinguish in the treatment of gastric cancer has obtained positive data, which will be reported at the ascogi meeting.
(2) on January 17, AstraZeneca / STC jointly announced that FDA had accepted the supplementary biological product license application (SBLA) of HER2 antibody drug conjugate (ADC) enhertu (trastuzumabderuxtecan) and granted priority review qualification. The application is intended for adult patients who have previously received anti HER2 treatment for non resectable or metastatic HER2 positive breast cancer.
(3) on January 18, youshibi released the positive interim analysis results of a phase 3 clinical trial of anti-il-17a / F antibody bimzelx (bimekizumab). Trials have shown that bimekizumab can effectively improve the clinical symptoms of adult patients with active non radiological axial spondyloarthritis (NR axspa).
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.
