BeiGene's PARP Inhibitor Pamiparib Receives NMPA Approval for Advanced Ovarian Cancer

[May 7, 2021 / Pharmaceutical News Digest]BeiGene’s PARP Inhibitor Pamiparib Officially Approved for Market Launch; Tailong Pharmaceutical Independent Director Wang Bo Resigns Upon Expiration of Term; Luye Pharma’s COVID-19 Neutralizing Antibody Completes Phase I Clinical Trial…Daily Fresh Pharmaceutical and Medical News, Quick Read with You!

Part 1 Policy Brief

National Healthcare Security Administration Issues Notice on Accelerating the Direct Inter-Provincial Settlement of Outpatient Expenses

On May 6, the National Healthcare Security Administration, in conjunction with the Ministry of Finance, released for public notice the “Notice on Accelerating the Direct Cross-Provincial Settlement of Outpatient Expenses.” The notice emphasizes that, to address the urgent and pressing difficulties faced by the public in settling cross-provincial healthcare expenses incurred outside their home provinces, efforts will be vigorously accelerated to promote the direct cross-provincial settlement of outpatient costs. (National Healthcare Security Administration)

Part 2: Industry and Economic Observation

TaiLong Pharmaceutical Independent Director Wang Bo Resigns Upon Expiration of Term

On May 7, Tailong Pharmaceutical issued an announcement stating that the Board of Directors had recently received a written resignation report from Mr. Wang Bo, an independent director of the company. Due to having served continuously as an independent director for six years, Mr. Wang Bo has applied to resign from his positions as an independent director of the Eighth Board of Directors and from related roles in the various specialized committees under the Board, in accordance with relevant regulations. (Tailong Pharmaceutical Announcement)

WuXi Biologics Announces Completion of Three Acquisitions

WuXi Biologics Announces Completion of Acquisitions of Bayer’s Drug Substance Production Facility in Wuppertal, Germany, Pfizer China’s Drug Substance and Drug Product Production Facility in Hangzhou, and Suzhou BioPharm (Suqiao Bio)WuXi Biologics announced today that it has completed the acquisitions of three assets: Bayer’s drug substance production facility located in Wuppertal, Germany; Pfizer China’s drug substance and drug product production facility in Hangzhou; and Suzhou BioPharm (Suqiao Bio), a Chinese contract research, development, and manufacturing organization (CRDMO) for biologics. The acquired drug substance and drug product production facilities will sequentially initiate GMP manufacturing within this year. (Sina Medical News)

Merck’s COVID-19 Bet Fails, Resulting in $493 Million Loss

Recently, in a Form 10-Q filed with the U.S. Securities and Exchange Commission, Merck & Co., Inc. (MSD) disclosed that it incurred a $170 million loss on a COVID-19 candidate drug acquired through its acquisition of Oncolmmune, due to the termination of the clinical development program. (Sina Pharmaceutical News)

BD Spins Off Diabetes Care Business into an Independent Publicly Listed Company

BD Announces Plan to Spin Off Diabetes Care Business into Independent Public Company “NewCo” in First Half of 2022; Devdatt Kurdikar, Current Global President of BD Diabetes Care, to Serve as CEO of the New Entity (Sina Medical News)

Fanenshi Bio Completes $40 Million Series B Financing

On May 6, Vanes Bio announced the completion of its $40 million Series B financing round, led by Sequoia Capital China, with participation from Deyi Capital, Volcanic Stone Investment, Kangxi Global Investment Fund, and Wenzhou Fund. Existing shareholders Xianfeng Qiyun and angel investors also increased their investments. (Medical Observer)

Bobang Fangzhou Completes Over RMB 50 Million in Series A Financing

Bobang Fangzhou Recently Completed Over RMB 50 Million in Series A Financing, Invested by Funds Under China Venture Capital Co., Ltd., Fortune Capital, and Tasly Capital, with Jianyihui (Chaoshan Capital) Serving as the Exclusive Financial Advisor. (Arterial Network)

Medic Secures RMB 10 Million in Series A Funding

Recently, MSD completed a Series A financing round worth tens of millions of RMB, with the investment led by Yushan Capital’s Leading Health and Medical Fund. (Arterial Network)

Part 3 Pharmaceutical News and Medical Updates

Luye Pharma Completes Phase I Clinical Trial of COVID-19 Neutralizing Antibody

On May 6, Luye Pharma Group announced that LY-CovMab, an innovative antibody product independently developed by its holding subsidiary, Boan Biotech, for the treatment of COVID-19, has completed Phase I clinical trials in China, demonstrating favorable safety and tolerability. (Insight Database)

Astellas’ New Drug Xtandi for Hormone-Sensitive Prostate Cancer Receives EU Approval for New Indication

Recently, Astellas announced that the European Commission has approved a new indication for Xtandi: for the treatment of adult patients with metastatic hormone-sensitive prostate cancer. This approval is based on data from the pivotal Phase 3 ARCHS study. (Sina Pharmaceutical News)

GSK’s Intravenous/Subcutaneous Benlysta Combination Therapy Approved in the EU

On May 5, GlaxoSmithKline announced that the European Commission has approved the expanded use of intravenous and subcutaneous formulations of BENLYSTA in combination with background immunosuppressive therapy for the treatment of adult patients with active lupus nephritis, excluding those with systemic lupus erythematosus. (Sina Pharmaceutical News)

CStone Pharmaceuticals’ Ivosidenib for Cholangiocarcinoma Receives FDA Priority Review

On the 7th, the U.S. Food and Drug Administration accepted CStone Pharmaceuticals’ supplemental new drug application for ivosidenib, a therapeutic product indicated for the treatment of previously treated cholangiocarcinoma patients with isocitrate dehydrogenase-1 (IDH1) mutations. The application has been granted priority review, shortening the review timeline from 10 months to 6 months. (Cailianshe)

Roche’s New Drugs for Hemophilia and Neuromyelitis Optica Spectrum Disorders Approved in China

On May 7, the website of the National Medical Products Administration (NMPA) showed that two new drugs under Roche received drug approval documents. The approved drugs are emicizumab for patients with hemophilia A and satralizumab for patients with NMOSD. (Sina Pharmaceutical News)

BeiGene’s PARP Inhibitor Pamiparib Officially Approved for Market Launch

On May 7, the NMPA announced that pamiparib, a PARP inhibitor from BeiGene, was officially approved for marketing. It is indicated for the treatment of patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have received at least two prior lines of chemotherapy and harbor deleterious or suspected deleterious germline BRCA mutations. (Sina Medical News)

Sichuan Meidakang Jiale Pharmaceutical’s Docetaxel Injection Approved via Supplemental Application and Passes Consistency Evaluation

Recently, the official website of the National Medical Products Administration (NMPA) showed that Sichuan Meidakang Jiale Pharmaceutical’s Docetaxel Injection was approved through a supplemental application. Data indicates that docetaxel is a taxane anticancer drug that exerts its antitumor effects by interfering with the microtubule network essential for cell mitosis and interphase cellular functions. (Menet)

Chengdu Better Pharmaceutical's Ceftazidime for Injection Approved via Supplemental Application and Passed Consistency Evaluation

Recently, the official website of the National Medical Products Administration (NMPA) announced that Chengdu Better Pharmaceutical’s ceftazidime for injection has been approved through a supplementary application and passed the consistency evaluation. Data indicates that ceftazidime is a potent, broad-spectrum third-generation cephalosporin antibiotic. (Menet News)

CR Double-Crane’s Subsidiary Nifedipine Sustained-Release Tablets (II) Pass Consistency Evaluation

On May 7, China Resources Double-Crane Pharmaceutical issued an announcement stating that its subsidiary had received the “Notice of Approval for Supplementary Drug Application” for Nifedipine Sustained-Release Tablets (II), approved and issued by the National Medical Products Administration. The drug has passed the consistency evaluation of quality and efficacy for generic drugs. It is primarily indicated for the treatment of chronic stable angina, vasospastic angina, and primary hypertension. (Announcement from China Resources Double-Crane Pharmaceutical)

Zai Lab’s $175 Million “First-in-Class” Therapy Files for Clinical Trial Approval

The latest public announcement from the Center for Drug Evaluation (CDE) of the National Medical Products Administration shows that Zai Lab has submitted three clinical trial applications for efgartigimod injection, which have been accepted by the CDE. It is reported that the indications involved with efgartigimod include myasthenia gravis, pemphigus vulgaris, immune thrombocytopenia, chronic inflammatory demyelinating polyneuropathy, and others. (Medical Horizon)

Approval Granted for Clinical Trial of SSGJ-612 for Injection, Independently Developed by 3SBio

On May 7, 3SBio Inc. announced that its independently developed injectable drug SSGJ-612 had received the "Notice of Approval for Clinical Drug Trials" issued by the National Medical Products Administration (NMPA), and clinical trials will be conducted in the near future. It is understood that SSGJ-612 is the first therapeutic macromolecular monoclonal antibody to enter the clinical development stage, which has evolved from the classic HER2 receptor. It antagonizes the extracellular domain III of HER2 and is fully independently innovative from its mechanism of action to product development. (Announcement by 3SBio Inc.)

70 Million Doses of Johnson & Johnson Vaccine in the U.S. May Be Discarded Due to Contamination

On May 7, The New York Times reported that 70 million doses of Johnson & Johnson’s COVID-19 vaccine might be discarded due to contamination. Among these, millions of doses had already been shipped to the European Union, Canada, and South Africa. According to the report, in March this year, a factory in Baltimore, USA, accidentally contaminated Johnson & Johnson vaccines in production with a harmless virus used for producing AstraZeneca vaccines, resulting in up to 15 million doses of Johnson & Johnson vaccines being discarded because they did not meet purity requirements. (Cailianshe)