BeiGene Submits IND Application in China for First-in-Class HPK1 Inhibitor BGB-15025 Capsule

【May 24, 2021 / Medical News Digest】Nanjing Pharmaceutical director resigns; another pharma company withdraws from STAR Market listing; Tongyuankang Pharmaceutical completes nearly RMB 400 million Series B+ financing round...Daily Latest Pharmaceutical & Medical News: A Quick Read to Keep You Informed!

Part 1 Policy Brief

NMPA's Latest Notice on Voluntary Recall of Medical Devices Involving Vascular Grafts and Other Devices

On May 21, the National Medical Products Administration issued the latest notice on voluntary recalls of medical devices, including Zimmer GmbH's voluntary recall of the Metallic Intramedullary Nail and W.L. Gore & Associates, Inc.'s voluntary recall of the GORE PROPATEN Vascular Graft, among others. All are classified as Class III recalls. (National Medical Products Administration)

Latest Update on Volume-Based Procurement! Beijing Implementation Date Confirmed

On May 21, the Beijing Municipal Healthcare Security Administration issued the 《Notice on Relevant Matters Concerning the Implementation of the Winning Bid Results of the First, Second, and Fourth Batches of National Centralized Drug Procurement and the Joint Volume-Based Drug Procurement in the Beijing-Tianjin-Hebei Region》. The notice states that Beijing will synchronize and unify the implementation schedules for these programs, and will fully implement the winning bid results and supporting policies of the aforementioned centralized procurements starting from 00:00 on May 29, 2021. (Beijing Municipal Healthcare Security Administration)

NMPA: Cancels Registrations of 283 Drugs, Approves Registrations of 139 Medical Devices

On May 24, the National Medical Products Administration (NMPA) announced that, in accordance with relevant laws, it has decided to cancel the registration certificates for 283 drugs, including Megestrol Acetate Dispersible Tablets, as well as 139 approved medical device products. Among these, 100 are domestic Class III medical devices, 19 are imported Class III medical devices, 19 are imported Class II medical devices, and 1 is a medical device from Hong Kong, Macao, and Taiwan. (National Medical Products Administration)

Part 2: Industry Observation

Nanjing Pharmaceutical Director Resigns

On May 24, Nanjing Pharmaceutical Co., Ltd. announced that on May 21, 2021, its Board of Directors received a written resignation letter from Director Mr. Richard Joseph Anthony Gorsuch. Due to other work arrangements, Mr. Richard Joseph Anthony Gorsuch has applied to resign from his positions as a Director of the Eighth Session of the Board of Directors, as well as a Member of the Board's Nomination and Human Resources Planning Committee and the Remuneration and Performance Appraisal Committee. (Nanjing Pharmaceutical Announcement)

Li Shuhong Resigns as Director and Other Positions at Haobo Bio-Pharma

On May 24, Jiangsu Haoyibo Biomedical Co., Ltd. announced that the Board of Directors recently received a written resignation letter from Ms. Li Shuhong, Director, Board Secretary, and Chief Financial Officer. Ms. Li Shuhong has resigned from her positions for personal reasons and has completed the handover of her duties. (Haoyibo Announcement)

Yet Another Pharmaceutical Company Halts STAR Market Listing Bid

Recently, the Shanghai Stock Exchange (SSE) announced its decision to terminate the review of Suzhou Ribo Life Science Co., Ltd.'s initial public offering (IPO) and listing on the Science and Technology Innovation Board (STAR Market). Prior to this, Ribo Life Science and its sponsor, Guotai Junan Securities Co., Ltd., had separately submitted to the SSE the "Application of Suzhou Ribo Life Science Co., Ltd. for Withdrawal of Application Documents for Initial Public Offering and Listing on the Science and Technology Innovation Board" and the "Application of Guotai Junan Securities Co., Ltd. for Withdrawal of Application Documents for Initial Public Offering and Listing of Suzhou Ribo Life Science Co., Ltd. on the Science and Technology Innovation Board," respectively, requesting the withdrawal of the application documents. (SSE)

GlaxoSmithKline Sells Innoviva for $392 Million

Recently, GlaxoSmithKline announced in a statement that it has decided to sell all 32 million shares of Innoviva common stock to Innoviva at $12.25 per share, with the expected total proceeds from the sale potentially reaching $392 million. (Sina Medical News)

# Fangsheng Pharmaceutical Subsidiary Baijun Medical Enters Strategic Partnership with DaVita

On the afternoon of the 24th, Baijun Medical, a subsidiary of Fangsheng Pharmaceutical, and U.S.-based Devita Company signed a strategic cooperation agreement in Changsha. The two parties will focus on China's renal dialysis industry and collaborate in areas including strategy, investment, and operational platforms. (Cailian Press)

Tongyuankang Pharmaceutical Completes Nearly RMB 400 Million Series B+ Funding Round

Recently, Tongyukang Biopharma announced the completion of a Series B+ financing round amounting to nearly RMB 400 million. The round was led by Sealand Innovation Capital, with Haibang Fenghua and Zheshang Venture Capital participating as co-investors. Existing shareholders Wenzhou Investment and Changxing Financial Holding made additional investments. Haoyue Capital continued to serve as the exclusive financial advisor. (Jike Pharma News)

Gensco Medical Secures Hundreds of Millions of US Dollars in Series B Funding

According to reports, emerging medical technology company Jieshi Medical Technology Group recently secured hundreds of millions of U.S. dollars in its Series B financing round. The round was led by global leading investment firm General Atlantic, with CITIC Capital and other institutions participating. Meanwhile, all major shareholders from the Series A round also participated in the follow-on investment. Subsequently, Sun Lefei, Managing Director and Head of China Healthcare at General Atlantic, joined the board of directors of Jieshi Medical. (Cailian Press)

Part 3: Pharmaceutical & Medical News

Humanwell's Class 1 Innovative Drug Fospropofol Disodium for Injection Receives Marketing Approval

On May 24, the official website of the National Medical Products Administration (NMPA) indicated that Humanwell's Class 1 new drug, fospropofol disodium for injection, has received marketing approval for the indication of induction of general anesthesia. (MENET)

Xintian Pharmaceutical's Avanafil Tablets Receive Drug Registration Certificate

Recently, Xintian Pharmaceutical announced that its wholly-owned subsidiary, Huilun Jiangsu Pharmaceutical, has received the Drug Registration Certificate for Avanafil Tablets, approved and issued by the National Medical Products Administration (NMPA). Avanafil Tablets are primarily used for the treatment of erectile dysfunction. (Xintian Pharmaceutical Announcement)

HEC Aripiprazole Orally Disintegrating Tablets Approved

On May 24, Dongyang Sunshine announced that its subsidiary recently received the “Drug Registration Certificate” approved and issued by the National Medical Products Administration (NMPA). Aripiprazole is indicated for the treatment of schizophrenia, belongs to second-generation antipsychotics, and is also listed in the 2018 edition of the “National Essential Medicines List”. (Dongyang Sunshine Announcement)

Gan & Lee Pharmaceuticals' Protamine Recombinant Human Insulin (Premixed 30R) Officially Approved

On May 24, the NMPA issued drug approval documents, officially approving Gan & Lee Pharmaceuticals' Protamine Recombinant Human Insulin Injection (Premixed 30R), a second-generation insulin. This marks the company's first approved second-generation insulin product. (Insight Database)

Nanjing Chia Tai Tianqing's 「Tolvaptan」 Gains Marketing Approval, Second Domestic Manufacturer

On May 24, the NMPA issued an approval notice, granting marketing authorization to Nanjing Chia Tai Tianqing's Class 4 generic drug “Tolvaptan”, making it the second domestically produced product approved in China. The drug is indicated for the treatment of clinically significant hypervolemic and euvolemic hyponatremia, including patients with heart failure and syndrome of inappropriate antidiuretic hormone secretion (SIADH). (Insight Database)

Yangtze River Pharmaceutical Group, CSPC Group “Linagliptin” Approved for Marketing

On May 24, the NMPA issued approval documents for 「Linagliptin Tablets」, a Class 4 generic drug from Yangtze River Pharmaceutical Group and CSPC Ouyi Pharmaceutical, both of which received marketing authorization. The drug is indicated for the treatment of type 2 diabetes as monotherapy, or in combination with metformin, or in combination with metformin and a sulfonylurea. (Insight Database)

Haisco: IND Application for HSK21542 Injection for a New Indication Accepted

On May 24, Haisco announced that the company has received the Acceptance Notice for the Investigational New Drug (IND) application for a new indication of its innovative drug, HSK21542 injection. HSK21542 injection is a novel analgesic with independent intellectual property rights developed by Haisco, intended for the treatment of indications such as acute and chronic pain and pruritus. (Haisco Announcement)

Novartis Innovative Triple Therapy Approved in China

On May 24, the latest public notice from the China National Medical Products Administration (NMPA) indicated that Novartis's indacaterol/glycopyrronium/mometasone furoate inhalation powder has been officially approved in China. It is reported that the drug is primarily indicated for the treatment of patients with inadequately controlled asthma. (Yiyao Guanlan)

Sailong Pharmaceutical: The Company's Omeprazole Sodium for Injection Passes the Consistency Evaluation for Generic Drugs

On May 24, Sailong Pharmaceutical announced that the company's Omeprazole Sodium for Injection has passed the consistency evaluation for generic drugs. The primary indication of Omeprazole Sodium for Injection is for the treatment of acute upper gastrointestinal bleeding caused by duodenal ulcers, gastric ulcers, acute gastric mucosal lesions, compound ulcers, and other conditions. (Sailong Pharmaceutical Announcement)

BeiGene Submits IND for First-in-Class HPK1 Inhibitor in China

On May 24, the official website of the CDE indicated that the clinical trial application for BGB-15025 capsules, BeiGene's first-in-class HPK1 inhibitor, has been formally accepted by the NMPA for the treatment of solid tumors. (PharmaCube Info)