Nanchang Pharmaceutical Penalized for GMP Violations; Montelukast Sodium Receives Black Box Warning

[March 5, 2020 / Pharmaceutical News Overview]As of 24:00 on March 4: 139 new confirmed cases reported; Chen Zhimin, independent director of Zuoli Pharmaceutical, resigns; Nanchang Pharmaceutical fined for GMP violations; GSK plans to divest its antibiotics business; CSPC’s “Rivaroxaban Tablets” approved for market launch...Daily Fresh Pharmaceutical and Medical News: Sudu She Joins You in Paying Close Attention!

Part 1 Epidemic Briefing

As of 24:00 on March 4: 139 newly confirmed cases

From 00:00 to 24:00 on March 4, 31 provinces (autonomous regions and municipalities) and the Xinjiang Production and Construction Corps reported 139 newly confirmed cases, 31 new deaths (all in Hubei), and 143 new suspected cases. On that day, 2,189 patients were discharged after recovery, 6,584 close contacts were released from medical observation, and the number of severe cases decreased by 464. (Official website of the National Health Commission)

Clinical Treatment Protocol for Convalescent Plasma from Recovered COVID-19 Patients (Trial Version 2) Released

On the 4th, the National Health Commission issued a notice on printing and distributing the Clinical Treatment Plan for Convalescent Plasma from Recovered COVID-19 Patients (Trial Version 2). Accordingly, based on the time required for recovered patients to produce neutralizing antibodies in their plasma, the provision “at least three weeks since the onset of initial symptoms” was added. (Sina Medical News)

Part 2 Industry and Economics Observation

Zuoli Pharmaceutical Independent Director Chen Zhimin Resigns

On the 4th, Zuoli Pharmaceutical issued an announcement stating that the company’s Board of Directors had received a resignation application from Ms. Chen Zhimin, an independent director of the company. Due to personal reasons, Ms. Chen Zhimin has applied to resign from her position as an independent director on the sixth session of the Board of Directors, and simultaneously from her roles as a member of the Audit Committee and Chair of the Remuneration and Appraisal Committee under the same board. Following her resignation, Ms. Chen Zhimin will no longer hold any positions within the company. (Sina Medical News)

Nanchang Pharmaceutical Fined for GMP Violations!

The Jiangxi Provincial Medical Products Administration has published the administrative penalty information regarding Jiangxi Nanchang Pharmaceutical Co., Ltd.'s violation of Good Manufacturing Practice (GMP). In accordance with Article 9, Paragraph 1 of the Drug Administration Law of the People's Republic of China (Presidential Order No. 27), the Jiangxi Provincial Medical Products Administration imposed an administrative penalty ordering the suspension of production for rectification for thirty days and a fine of RMB 20,000. (Jiangxi Provincial Medical Products Administration)

GSK Plans to Sell Its Antibiotics Business

According to PMlive, GlaxoSmithKline (GSK) plans to divest part of its antibiotics business. According to insiders, the purpose of this asset divestiture by GSK is to focus on core businesses, including oncology immunotherapy. (PharmaCube)

Part 3 Pharmaceutical News

Shanghai Releases “4+7” Renewal Rules

Shanghai Sunshine Pharmaceutical Procurement Network Releases "Notice on Matters Concerning the Expiration of Procurement Agreements for Selected Drugs from the '4+7' City Centralized Drug Procurement Program in This Municipality" According to the notice, even if companies that won bids in the original "4+7" program fail to secure bids in the expanded alliance procurement, they retain the discretion to decide whether to renew their contracts based on their own volition. Should the original winning enterprises opt not to renew, Shanghai Municipality will have a broader range of alternatives available, reflecting mutual respect. (Shanghai Sunshine Pharmaceutical Procurement Network)

Inner Mongolia Announces Top 10 Online Drug Purchases in January

The Inner Mongolia Autonomous Region Healthcare Security Administration released its business brief for January 2020, announcing the top 10 drugs by online procurement amount in the region for that month. The combined total amounted to RMB 74 million, accounting for 9.58% of the total drug procurement value. According to business briefs from multiple months in the region, the top 10 list has remained relatively stable. AstraZeneca’s budesonide suspension for inhalation, Pfizer’s cefoperazone sodium and sulbactam sodium for injection, and Novo Nordisk’s insulin aspart 30 injection ranked in the top three. (PharmCube)

Montelukast Sodium Adds Black Box Warning to Alert for Neuropsychiatric Event Risks

The U.S. FDA recently issued a safety warning, requiring the addition of a boxed warning to montelukast sodium to strengthen existing warnings regarding the risk of neuropsychiatric events associated with the drug. Montelukast sodium is marketed under the brand name Singulair (Shunerning) and as generic medications for the treatment of asthma and allergic rhinitis (hay fever). The boxed warning advises healthcare providers to avoid prescribing montelukast sodium for patients with mild symptoms, particularly those with allergic rhinitis. (Sina Medical News)

CSPC Pharmaceutical Group’s “Rivaroxaban Tablets” Approved for Market Launch

CSPC Ouyi’s rivaroxaban tablets, submitted under the new Class 4 application pathway, have been approved by the National Medical Products Administration (NMPA) and are deemed to have passed the consistency evaluation, making CSPC Ouyi the second company in China to achieve this milestone for this product, following Chia Tai Tianqing. (PharmCube)

Two More Companies' Eszopiclone Tablets Pass Consistency Evaluation

Shanghai Pharma’s Sino-West Pharmaceutical and Kanghong Pharmaceutical have both had their sedative-hypnotic drug, eszopiclone tablets, pass the consistency evaluation. Previously, Tasly was the first to achieve consistency evaluation approval for this product. (PharmaCube)

Youyou Pharmaceutical’s Duloxetine Proposed for Priority Review

CDE Website Updates Public Notice on Drugs Proposed for Priority Review; Three Application Numbers for Pharmascience’s Duloxetine Hydrochloride Enteric-Coated Capsules (involving strengths of 20 mg, 30 mg, and 60 mg) Are Proposed to Be Included in the Priority Review Program, with the Reason Stated as “Manufactured on the Same Production Line and Already Marketed in the United States in 2019; Generic Drug Applications for Domestic Marketing Are Included in the Priority Review Program.” (Menet Network)

Amgen Accelerates Entry into Chinese Market with Development of Bispecific Antibody AMG 199

CDE Accepts and Publicly Discloses Amgen’s Investigational New Drug AMG 199 for Clinical Trial Application in China. AMG 199 is a bispecific antibody based on the BiTE technology platform, intended for the treatment of metastatic gastric cancer and gastroesophageal junction cancer. (CPhI Pharma Online)

Takeda to Develop Plasma-Derived Therapy for COVID-19

Takeda Announces Development of Polyclonal Hyperimmune Globulin (H-IG) Therapy (TAK-888) Targeting SARS-CoV-2 for the Treatment of Severe COVID-19 Patients. H-IG is derived from plasma recovered from patients who have recovered from COVID-19 or from individuals vaccinated in the future. Current clinical data indicate its potential as an effective therapy for COVID-19. Takeda stated that it is engaging in discussions with health regulatory authorities in multiple countries across the United States, Asia, and Europe to rapidly advance the TAK-888 research program. (PharmCube)

Allergan/Editas In Vivo Gene Editing Therapy Completes First Patient Dosing

Allergan and Editas Medicine jointly announced that the Phase 1/2 clinical trial of the gene therapy AGN-151587 (EDIT-101) for Leber congenital amaurosis type 10 (LCA10), a hereditary blindness disorder, has completed dosing of the first patient. This marks the world’s first CRISPR genome-editing drug administered to humans. (Sina Medical News)

Roche’s GALAD Blood Test Receives FDA Breakthrough Device Designation

Roche Announces FDA Breakthrough Device Designation for Elecsys GALAD Score Assay to Support Early Diagnosis of Hepatocellular Carcinoma (WuXi AppTec)

Lorlatinib, a Potent Last-Resort Medication, Launched in Hong Kong, China

The third-generation ALK inhibitor lorlatinib (brand name: Lorbrena) is currently marketed in Hong Kong, China, and has been approved for the treatment of patients with ALK-positive advanced non-small cell lung cancer (NSCLC) who have progressed on crizotinib or at least one other ALK inhibitor. (CPhI Pharma Online)

Johnson & Johnson’s S1P1 Modulator Ponesimod Files for Market Approval

Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, recently announced that it has submitted a marketing authorization application to the European Medicines Agency, seeking approval for ponesimod for the treatment of adult patients with relapsing forms of multiple sclerosis. (Bioon)

Kura Oncology’s Lymphoma Drug Tipifarnib Granted Fast Track Designation

Kura Oncology recently announced that the U.S. FDA has granted Fast Track designation to its lead candidate drug, tipifarnib, for the treatment of adult patients with relapsed or refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, and peripheral T-cell lymphoma, not otherwise specified. (Bioon)

Sanofi’s Cablivi Approved in Canada for the Treatment of Acquired Thrombotic Thrombocytopenic Purpura

Sanofi recently announced that Health Canada has approved the nanobody drug Cablivi (caplacizumab) through the Priority Review pathway, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura. (Bioon)