Pharmaceutical News of the Week (July. 13th-July. 17th) | PharmaSources.com - Updates on Policies,Transactions and Others

With the third week of July coming to a close, let’s review the hot events of the pharmaceutical industry this week. The news involved 5 sections: approval, R&D, policies, transactions, and miscellany that happened during July 13-17, including 30 pieces.

Policies

23. The NMPA issued the Reply of the Department of Comprehensive Affairs, Planning, and Finance Affairs of the National Medical Products Administration on Issues Related to the Identification of Counterfeit and Inferior Drugs on July 14 to define that some of the punishment decisions on counterfeit and inferior drugs are not required to state the quality inspection conclusions of pharmaceutical product inspection bodies.

24. The CDE issued the Guidelines on the Management of Clinical Trials during the COVID-19 Pandemic (Trial) on July 14, which came into effect on the same day. The Guidelines give suggestions for the clinical trials of COVID-19 drugs (including vaccines) to be urgently approved and other drugs in development during the pandemic for the reference of applicants and researchers.

Transactions

25. BeiGene announced the completion of USD2.08 billion primary offering on July 13, which becomes the largest equity financing in the history of global biomedicine so far and will be mainly used to expand the company’s scale and influence in China. BeiGene has now 2 new drugs approved for marketing, separately, zanubrutinib, a small-molecule BTK inhibitor, and tislelizumab injection, an anti-PD-1 monoclonal antibody.

26. Arctic Vision announced on July 14 that it reached an agreement in connection with USD32 million Series A financing led by Morningside Ventures, together with its original incubation investors Nan Fung Life Sciences and Pivotal BioVenture Partners China. Arctic Vision will use the proceeds to gear up the clinical trials for ARVN001. ARVN001 is a suspension of the triamcinolone acetonide formulated for suprachoroidal space (SCS) injection. Its first pursued indication in China will be macular edema associated with uveitis (UME).

27. Revitope and Junshi Biosciences announced that both parties entered into a strategic research collaboration on July 14. Leveraging Revitope’s protein engineering platform together with Junshi Biosciences’ novel antibody, both parties will develop first-in-class dual-antigen targeting T-cell engaging therapies for cancers, and Revitope will design up to 5 TEAC molecules against tumor targets selected by Junshi Biosciences.

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Miscellaneous

28. On July 13, Antengene announced the appointment of Dirk Hoenemann as Head of Medical Affairs for Asia Pacific Region (APAC) and Early Clinical Development. Dirk will be responsible for establishing the Antengene APAC Medical Affairs function, structure and processes, and the clinical development strategies for multiple early phase programs and small-molecule compounds.

29. Shanghai Shyndec Pharmaceutical announced on July 15 that it received the written resignation from Mr. Yang Jun as the company’s Director and President on July 14 due to job-related reasons; after resignation, Mr. Yang Jun will not hold any position at the company, and the company’s Chairman Mr. Zhou Bin will serve as Acting President.

30. Zelgen Biopharmaceuticals announced on July 16 that according to the Resolution concerning the Appointments of Senior Management of the Company deliberated and passed by the company’s Board of Directors, it resolved to hire Zhang Junli as the company’s Deputy General Manager. Zhang Junli is 58 years old and has been working in the biopharmaceutical field for 27 years.

Related News:

Pharmaceutical News of the Week (July. 13th-July. 17th) | PharmaSources.com - Updates on Approvals

About  the Author:    

Caicai, a Master of Pharmacy from Shanghai Jiaotong University, used to work in the Institute of Science and Technical Information. Currently as a practitioner in the drug surveillance system, she is good at interpreting industry regulations, pharmaceutical research developments, etc.

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