Pharmaceutical Business in China and Worldwide (September)(2023)

NMPA 

Listing Approval:

1.   On August 29, GenFleet and Verastem announced that they had entered into an exclusive licensing and early co-development agreement. Verastem will act as the exclusive partner for the global development and commercialization rights of three innovative therapies developed by GenTank and led by RAS pathway-targeted therapies outside of Greater China (including Chinese mainland, Hong Kong, Macau, and Taiwan). The company will receive potential follow-on milestone payments totaling more than $625 million.

2.   On August 31, Huadong Pharmaceutical's wholly-owned subsidiary, Sino-US Huadong, and MC2 Therapeutics announced that they had reached an exclusive license agreement. China East China has obtained exclusive licenses from Wynzora in Greater China, including clinical development, registration and commercialization rights. Wynzora cream is a cream-like, fixed-dose combination consisting of calcipotriene and betamethasone dipropionate for the topical treatment of plaque psoriasis.

3.   On September 1, Edding Group and Nanopeptide announced that they had reached a strategic cooperation agreement. Nanopeptide exclusively authorized Eden to develop, manufacture and commercialize two small interfering RNA (siRNA) drugs targeting ANGPTL3 and Lp(a) in Greater China and Southeast Asia, and Eden paid an upfront payment, milestone payment and sales royalty for future marketed products.

4.   On September 6, Zenas BioPharma and Bristol Myers Squibb announced that they have signed a license and collaboration agreement to develop and commercialize obexelimab in Taiwan and Hong Kong, as well as in Japan, South Korea, Singapore and Australia. Obexelimab injection is an experimental bifunctional, non-cytolytic, humanized monoclonal antibody that binds to CD19 and FcγRII.b to inhibit B lineage cell activity and mimic the action of antigen-antibody complexes.

5.   On September 20, Orionis Biosciences announced that it has entered into a collaboration agreement with Genentech, a Roche company, to jointly develop novel small molecule drugs targeting challenging targets in major disease areas, including tumor and neurodegenerative diseases. Under the terms of the agreement, Orionis will be responsible for the discovery and optimization of molecular gels for Genentech's designated targets, while Genentech will be responsible for the subsequent preclinical, clinical development, regulatory filing, and commercialization of these small molecules.

6.   On September 20, Pepti Dream announced that it has reached a cooperation agreement with Genentech, a subsidiary of Roche. Under the agreement, PeptiDream will use its proprietary Peptide Discovery Platform System (PDPS) technology to discover, optimize and develop macrocyclic peptide candidates for the development of peptide-RI drug conjugates targeting Genentech's targets of interest.

7.   On September 20, Yuanda Shuyang Pharmaceutical, a wholly-owned subsidiary of Grand Life Sciences, announced that it had reached a cooperation agreement with Suzhou Alphamab Oncology. According to the agreement, Grand Shuyang will be solely responsible for the marketing and commercial sales of KN057 in Greater China, and will pay Corcology Oncology an aggregate equity payment of up to RMB500 million (including upfront payment and milestone payment) and tiered sales commissions. Alphamab Oncology will continue to be responsible for the follow-up clinical studies, NDAs and product supply of KN057 for hemophilia A and hemophilia B.

8.   On September 21,Everest Medicines announced that it has entered into a partnership agreement with Kezar Life Sciences (Kezar). Under the agreement, the company will jointly develop and commercialize Kezar's first clinical-stage drug candidate, zetomipzomib, in Greater China, South Korea and certain Southeast Asian countries. zetomipzomib is a first-in-class, selective immunoproteasome inhibitor for the treatment of a range of autoimmune diseases, including lupus nephritis (LN).

9.   On Sept. 26, Intercept announced that it would hand over its liver disease drug Okiva and other projects in its pipeline to Italian pharmaceutical company Alfasigma at a price of $19 per share, following repeated FDA rejections of the company's NASH drug candidate obeticholic acid.

10.  On September 26, Caribou Biosciences disclosed in a filing with the U.S. Securities and Exchange Commission (SEC) that AbbVie has elected to terminate its collaboration and license agreement with Caribou on February 9, 2021 for two novel CAR-T cell therapies. The effective date of termination of the agreement is October 25, 2023.

11.  On September 28, CR double-crane announced that it would acquire 89.681% of the equity of Guizhou Tianan Pharmaceutical Co., Ltd. with its own funds of 260,355,691.22 yuan, including 55.586% of the equity of Tianan Pharmaceutical held by Jiangxi Boya Pharmaceutical Investment Co., Ltd. and 34.095% of the equity of Tianan Pharmaceutical held by China Resources Boya Biopharmaceutical Group Co., Ltd.

Listing

1.   On September 5, ImmuneOnco was officially listed on the Hong Kong Stock Exchange. Founded in 2015 with Dr. Wenzhi Tian as its chairman and chief executive officer, the company has developed a pipeline of 14 innovative drug candidates and has eight ongoing clinical programs, including next-generation CD47-targeting molecules and CD47-based bispecific molecules.

2.   On September 25, Youzhiyou Biopharma was officially listed on the Hong Kong Stock Exchange. Youzhiyou Biotech is committed to developing bispecific antibody (BsAb) therapies for the treatment of cancer-related complications, cancer, and senile ophthalmic diseases. According to the prospectus, the company's IPO on the Hong Kong Stock Exchange this time, the cornerstone investors are Optics Valley Health, Chuxing Yourui and Puhua Kaizhi.

other

1.   On September 6, the State Council issued a notice of appointment and dismissal, appointing Li Li as director of the National Medical Products Administration and Jiao Hong (female) as director of the National Medical Products Administration.

2.   On September 12, the FDA announced that it had issued warning letters to eight companies for illegally manufacturing and selling unapproved products for the treatment of conjunctivitis, cataracts, etcOphthalmic products for glaucoma and other diseases. The companies involved in the incident are Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.

3.   On September 20, National Health Commission of China, State Food of China and Drug Administration, and other six departments jointly released the "Second Batch of Rare Disease Catalog", which includes 86 rare diseases. According to the notice, the release of this catalogue is to thoroughly implement the "Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices", further strengthen the management of rare diseases in China, improve the level of diagnosis and treatment of rare diseases, and safeguard the health rights and interests of patients with rare diseases.