Pharmaceutical News of the Week (July. 6th-July. 10th) PharmaSources.com - Updates on Policies,Transactions and Others

With the second week of July coming to a close, let’s review the hot events of the pharmaceutical industry this week. The news involved 6 sections: approval, R&D, policies, transactions, listing and miscellany that happened during July 6-10, including 21 pieces.

Policies

16. The NMPA issued 3 documents including the Breakthrough Therapy Review Procedures (Trial), etc. on July 8 to cooperate with the implementation of the Provisions for Drug Registration. The said documents have come into effect since the issuing date, and the Opinions on Encouraging Priority Review and Approval for Drug Innovation (SYJYHG [2017] No. 126) issued by the former China Food and Drug Administration in Dec. 2017 was abolished at the same time.

Transactions

17. Ascentage Pharma announced on July 6 that it entered a global clinical study partnership with MSD, according to which, both parties will conduct a clinical study to evaluate the combination of APG-115, Ascentage Pharma’s MDM2-p53 inhibitor in development, and Keytruda (pembrolizumab), MSD’s anti-PD-1 monoclonal antibody, for the treatment of patients with advanced solid tumors.

18. Hisun Pharmaceutical announced on July 7 that the company was planning reorganization to purchase 49% equity of Hanhui Pharmaceuticals from HPPC through shares and convertible corporate bonds issuance and cash payment and raise supporting funds. The transaction will constitute a connected transaction and is expected to constitute major assets restructuring but not reorganization and listing.

Listing

SSE

19. Sunshine Guojian gave an announcement on the IPO and listing on the STAR Market on the evening of July 8, according to which, the company determined the IPO issue price on the STAR Market as RMB28.18/share and would conduct online and offline subscription from July 13. Sunshine Guojian is a controlled subsidiary of Hong Kong, S.A.R., China-listed 3SBio.

HKEX

20. Hepalink announced the allocation results of overseas listing foreign shares (H shares) on July 7, according to which, it planned to issue about 220 million H shares globally, including 88.038 million Hong Kong, S.A.R., China Offer Shares and about 132 million International Offer Shares at HKD18.40 per Offer Share. Founded in 1998, Hepalink began with heparin API and was listed on the Shenzhen Stock Exchange in 2010.

Miscellaneous

21. Hengrui Medicine announced on July 6 that its wholly-owned subsidiary: Shanghai Hengrui planned to jointly invest in establishing Ruilidi with Mr. Sun Piaoyang. The company will have registered capital of RMB100 million and be responsible for antiviral therapy R&D, production, sales and related import and export business.

Related News:

Pharmaceutical News of the Week (July. 6th-July. 10th) | 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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