Domestic First! Dongyangguang Pharma's Oseltamivir Capsules Approved in the U.S.

[March 6, 2020 / Pharmaceutical News Overview]As of 24:00 on March 5: 143 new confirmed cases; Central authorities release 28 opinions on deepening healthcare insurance reform; GSK CEO’s 2019 compensation exceeds $10 million; First Chinese-made drug! HEC Pharm’s oseltamivir approved for marketing in the U.S.; Huahai’s “entecavir tablets and aripiprazole tablets” approved for marketing in China...Daily Fresh Pharmaceutical and Medical News, Speed Read Society Pays Attention with You!

Part 1 Policy Brief

Central Authorities Release 28 Opinions on Deepening Healthcare Security Reform

On the evening of the 5th, Xinhua News Agency released the “Opinions of the Central Committee of the Communist Party of China and the State Council on Deepening the Reform of the Medical Security System,” which immediately sparked significant reactions from the government and the market. Although the “Opinions” focus on deepening medical insurance reform, they extensively address the broader “three-medical-linkage” reform. Stakeholders across sectors regard this as a programmatic document that will set the tone for China’s healthcare reforms over the next decade. (Xinhua News Agency)

As of 24:00 on March 5: 143 newly confirmed cases

From 0:00 to 24:00 on March 5, 31 provinces (autonomous regions and municipalities directly under the Central Government) and the Xinjiang Production and Construction Corps reported 143 newly confirmed cases, 30 new deaths (29 in Hubei Province and 1 in Hainan Province), and 102 new suspected cases. On that day, 1,681 patients were discharged after recovery, 5,457 close contacts were released from medical observation, and the number of severe cases decreased by 215. (Official website of the National Health Commission)

Selected vaccines are expected to enter clinical trials or emergency use in April

At the press conference held by the Joint Prevention and Control Mechanism of the State Council this afternoon, Zheng Zhongwei, Director of the Medical and Health Science and Technology Development Research Center under the National Health Commission, introduced that the scientific research task force for COVID-19 has specially established a dedicated team for vaccine development. The first batch selected eight institutions, established nine tasks, and advanced vaccine research along five technical routes. It is expected that in April, some vaccines may enter clinical trials or be approved for emergency use. (National Health Commission)

Part 2 Industry and Economic Observation

GlaxoSmithKline CEO’s 2019 Compensation Exceeds $10 Million

According to GSK’s annual report released recently, Walmsley’s total compensation in 2019 amounted to £8.37 million (approximately $10.81 million), representing a year-on-year increase of over 42%, with net earnings of £2.5 million. The increase was primarily driven by performance-based awards granted by the company, including annual bonuses and long-term incentive (LTI) awards, totaling £6.837 million. Meanwhile, her base compensation, comprising basic salary, benefits, and pension contributions, saw limited growth, amounting to £1.53 million. (Sina Pharmaceutical News)

Part 3 Pharmaceutical News

Fosun Kite CAR-T Marketing Application Proposed for Priority Review

On the 5th, the marketing application for Fosun Kite’s chimeric antigen receptor T-cell (CAR-T) therapy, yikicelgene injection (Acceptance No. CXSS2000006), was proposed to be included in the priority review under Category I(3) for drugs with significant therapeutic advantages. (Insight Database)

First Chinese Manufacturer! HEC Pharm’s Oseltamivir Approved for Market Launch in the United States

According to the U.S. FDA website, the Abbreviated New Drug Application (ANDA) for HEC Pharm’s anti-influenza drug Oseltamivir Phosphate Capsules was approved on March 4 (local time), covering three strengths: 30 mg, 45 mg, and 75 mg. Notably, this marks the first approval and market launch in the United States for a domestically produced oseltamivir phosphate formulation. (Sina Pharmaceutical News)

Huahai’s “Entecavir Tablets and Aripiprazole Tablets” Approved for Market Launch in China

Huahai Pharmaceutical Announces NMPA Approval of Two Class 4 Generic Drugs, Entecavir Tablets and Aripiprazole Tablets; Approved Under the New Registration Classification, They Are Deemed to Have Passed the Consistency Evaluation. (Huahai Pharmaceutical Announcement)

Huahai Pharmaceutical’s HB0017 Project Application Receives FDA Approval for Clinical Trials

On the 5th, Huahai Pharmaceutical issued an announcement stating that its subsidiary, Huabo Biologics, received notification from the U.S. FDA that the HB0017 project submitted by Huabo Biologics for clinical trial approval had been granted clearance.(Huahai Pharmaceutical Announcement)

First Domestic Marketing Application for Multiple Sclerosis Drug "Teriflunomide Tablets" Filed

On the 5th, the marketing application for the Class 4 generic drug "Teriflunomide Tablets," jointly submitted by Nanjing Haina Pharmaceutical and Shengshi Taike, was accepted by the CDE, making them the first companies in China to submit a marketing application for a generic version of teriflunomide. (Insight Database)

IL-5 Monoclonal Antibody "Mepolizumab" Approved for Clinical Trials in China for COPD

CDE Website Shows GlaxoSmithKline's "Mepolizumab Injection" Receives Implied Clinical Trial Approval for the Treatment of Chronic Obstructive Pulmonary Disease (COPD). (Insight Database)

The World’s Second RNAi Drug, Givlaari, Receives EU Approval

Alnylam Pharmaceuticals recently announced that the European Commission has approved Givlaari (givosiran) for the treatment of acute hepatic porphyria (AHP) in adolescents aged 12 years and older and adults. In the United States, Givlaari was approved in November 2019 for the treatment of adult patients with AHP. The drug is administered by healthcare professionals via subcutaneous injection once a month, with the dosage determined by actual body weight (2.5 mg/kg). (Sina Pharmaceutical News)

Allergan’s Long-Acting Glaucoma Therapy Receives FDA Approval

Allergan Announces FDA Approval of Durysta, a Sustained-Release Bimatoprost Implant Developed by the Company, for the Treatment of Patients with Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT). The press release noted that Durysta is the first and only biodegradable sustained-release implant capable of effectively lowering intraocular pressure (IOP) in patients with OAG and/or OHT. (WuXi AppTec)

India Approves First PPAR Dual Agonist for Market Launch

Zydus Cadila announced that the Indian Drug Controller has approved its dual PPARα/γ agonist, saroglitazar magnesium, for the treatment of patients with non-cirrhotic non-alcoholic steatohepatitis (NASH). The press release noted that saroglitazar magnesium is the first drug worldwide to be approved for the treatment of non-cirrhotic NASH. (WuXi AppTec)