Review of new drug market this week: from December 20, 2021 to December 24, 2021, The top 5 enterprises in the new drug sector: Yaoming junuo (+ 35.9%), tengshengbo Pharmaceutical (16.5%), Xiansheng Pharmaceutical (+ 6.9%), Hualing Pharmaceutical (+ 6.8%), Geli Pharmaceutical (+ 6.5%); the top 5 enterprises in the new drug sector: Keji Pharmaceutical (- 19.6%), Fuhong Hanlin (- 13.1%), Yunding Xinyao (- 13.1%), Rongchang Biology (- 12.6%) and Cinda Biology (- 8.4%).
Key analysis of the new drug industry this week: this week, Baiji Shenzhou announced that it had reached a cooperation agreement with Novartis on the development of tigit monoclonal antibody ociperlimab. Baiji Shenzhou will receive a cash advance of US $300 million from Novartis and an additional payment of US $600 million or US $700 million when Novartis exercises its own time-based option before or from the middle of 2023 to the end of 2023, Depends on obtaining the required antitrust approvals. In addition, after Novartis exercises its option, Baiji Shenzhou is entitled to receive up to US $745 million of Drug Administration approved milestone payment, US $1.15 billion of sales milestone payment, and royalty based on ociperlimab’s sales in the licensed area. In addition, after ociperlimab is approved for listing, Baiji Shenzhou will undertake 50% of the common commercialization activities and common medical affairs in the U.S. market, and have up to 25% of the common commercialization options in the Canadian and Mexican markets, with some funds provided by Novartis. Baiji Shenzhou leads the world in the development progress of tigit. At present, it has carried out two phase 3 clinical trials, only lagging behind Roche. We believe that based on this cooperation agreement, after ociperlimab is approved to be listed in the United States in the future, With the help of the cooperation agreement with Novartis (i.e. undertaking 50% of the common commercialization activities and common medical affairs in the U.S. market), Baiji Shenzhou is expected to further exercise its commercialization ability in the United States from the joint cooperation with Novartis, so as to lay a solid foundation for the commercialization of the next heavy proprietary drugs in the United States.
Approval & acceptance of new drugs this week: this week, 4 new drugs or new indications of new drugs were approved for listing in China, 29 new drugs were approved ind, 39 new drugs ind and 7 new drugs NDA were accepted.
Top 3 of China’s new drug industry this week focuses on:
(1) On December 21, Baiji Shenzhou announced that it had reached an agreement on option, cooperation and licensing with Novartis. The two sides will jointly develop, produce and commercialize Baiji Shenzhou’s tigit monoclonal antibody ociperlimab in North America, Europe and Japan. Baiji Shenzhou will receive a cash advance of US $300 million from Novartis and exercise its sole right before or during the middle of 2023 to the end of 2023 An additional payment of $600 million or $700 million will be obtained for the home’s time-based option, depending on the required antitrust approval. In addition, after Novartis exercises its option, Baiji Shenzhou is entitled to receive up to US $745 million of Drug Administration approved milestone payment, US $1.15 billion of sales milestone payment, and royalty based on ociperlimab’s sales in the licensed area.
(2) On December 20, Haosen pharmaceutical’s third-generation EGFR-TKI ametinib was approved as a new indication in China for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletion or exon 21 replacement mutation (L858R).
(3) in December 24th, Guangsheng Zhong Lin and Wuxi Apptec Co.Ltd(603259) signed a contract for cooperative development on New Coronavirus small molecule oral medicine 3CL protease inhibitor. 。 3CL protease belongs to cysteine protease. It is a key protease for New Coronavirus replication. Its structure and function are relatively conservative. It is an important target for the development of COVID-19 virus small molecule drugs. It has the advantages of good effect, broad spectrum and good safety.
Top 3 of overseas new drug industry this week focuses on:
(1) On December 20, Moderna released the mRNA covid-19 vaccine (elasomeran, mrna-1273) 50 μ G and 100 μ G dose enhanced preliminary neutralizing antibody data against Omicron variant. Compared with the non inoculated reinforcing needle, the currently approved 50 μ Enhanced needle inoculation with gmrna-1273 increased the neutralizing antibody level of Omicron mutant by about 37 times, 100 μ The neutralizing antibody level was increased about 83 times by g dose enhanced needle inoculation.
(2) On December 22, Pfizer announced that the US FDA had approved the emergency authorization application (EUA) for paxlovid, a new oral antiviral candidate of covid-19, for the treatment of non hospitalized children and adults with mild to moderate covid-19 infection and high risk of developing into severe diseases.
(3) On December 23, molnupiravir, a covid-19 oral drug of MSD and Ridgeback, was granted the FDA emergency use authorization (EUA) for the treatment of mild to moderate adult patients with covid-19. Molnupiravir is the world’s first oral antiviral drug approved for the treatment of mild to moderate covid-19 in adults, and was first approved for marketing in the UK on November 4, 2021.
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.
