Roche's ADC Drug Kadcyla Approved in China; BMS Launches New Biotech Venture Anteros Pharmaceuticals

[February 5, 2020 / Pharmaceutical News Overview]As of 24:00 on February 4: Cumulative confirmed cases in China reached 24,324; “Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 5)” released; Gilead’s 2019 financial report: Hepatitis C business declines, while hepatitis B drug Vemlidy emerges as a new growth driver; Bristol-Myers Squibb launches a biopharmaceutical startup; Viagra’s indication for pulmonary arterial hypertension is set to be approved in China...Daily Fresh Pharmaceutical News and Medical Updates: Quick Read Society Keeps You Informed!

Part 1 Epidemic Briefing

As of 24:00 on February 4, a total of 24,324 confirmed cases have been reported nationwide.

As of 24:00 on February 4, the National Health Commission had received reports from 31 provinces (autonomous regions and municipalities) and the Xinjiang Production and Construction Corps, with a cumulative total of 24,324 confirmed cases (one case was deducted in Hainan Province), 3,219 severe cases currently, 490 cumulative deaths, 892 cumulative discharges after recovery (one case each was deducted in Hainan Province and Hubei Province), and 23,260 suspected cases currently. (National Health Commission)

“Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 5)” Released

On the morning of the 5th, the “Diagnosis and Treatment Protocol for Novel Coronavirus-Infected Pneumonia (Trial Version 5)” was released. Compared with Version 4, three key aspects were revised: First, the epidemiological characteristics are more clearly defined, and the description of clinical manifestations is more detailed. Second, the clinical classification of cases is more refined; compared with Version 4, a “mild” type has been added, resulting in four categories: mild, moderate, severe, and critical. This enhances clinical classification guidance, facilitates more accurate case identification, and improves treatment outcomes. Third, therapeutic methods and approaches are more comprehensive. In addition to symptomatic and supportive treatments, including oxygen therapy, detailed classifications have been provided, laying the foundation for greater guidability and operability in clinical practice. (National Health Commission)

How to Make Home Isolation Safer? Prevention and Control Guidelines Are Here

On the 5th, the National Health Commission issued the Notice on Printing and Distributing the Guidelines for Infection Prevention and Control during Home Isolation and Medical Observation for the Prevention and Control of Novel Coronavirus-Infected Pneumonia (Trial), providing detailed guidance on infection prevention and control for individuals under home isolation and medical observation. (National Health Commission)

Part 2 Industry Observation

Bristol-Myers Squibb Launches Novel Biopharmaceutical to Improve the Lives of Patients with Inflammatory Diseases

Today, Bristol-Myers Squibb (BMS) and BioMotiv jointly announced the launch of Anteros Pharmaceuticals, a company focused on developing therapeutics for fibrosis and other inflammatory diseases. Anteros is the first biopharmaceutical company launched by the two partners since they entered into a collaboration agreement last September. (Chuangjianhui)

Gilead’s 2019 Financial Report: Hepatitis C Declines, While Hepatitis B Drug Vemlidy Emerges as a New Powerhouse!

On the 4th, Gilead announced its 2019 financial results, with total annual revenue reaching $22.449 billion, a 1.5% increase compared to 2018. Among this, sales revenue from HIV products amounted to $16.438 billion, representing a 12% increase compared to 2018, and accounting for 73.32% of the company's total revenue, making it Gilead's core business segment. (Pharmaceutical Cube)

Novartis China's Debut Performance

Novartis Achieved Total Revenue of $47.445 Billion in 2019, a 6% Year-on-Year IncreaseNovartis reported total revenue of $47.445 billion for the full year 2019, representing a 6% year-on-year increase. Among this, revenue from its innovative medicines business reached $37.714 billion, up 8% year on year; while its generics division, Sandoz, generated $9.731 billion in revenue, a 1% decline. The financial report also indicated that Novartis achieved double-digit growth in the Chinese market for the full year and is poised to double its performance in China by 2024. (E-Pharma Manager)

Shanghai RAAS Receives “Notice of Emergency Requisition of Production Capacity”

On the 3rd, Shanghai RAAS Blood Products Co., Ltd. received the “Notice on Emergency Requisition of Production Capacity” issued by the Shanghai Municipal Commission of Economy and Informatization. Authorized by the Shanghai Municipal People’s Government, and in accordance with Article 11, Paragraph 2, Article 12, Article 52, and Article 66 of the Emergency Response Law of the People’s Republic of China, as well as Article 35 of the Measures of Shanghai Municipality for Implementing the Emergency Response Law of the People’s Republic of China, the Commission has decided to urgently requisition your company’s medical protective supplies, pharmaceuticals, medical devices, and production capacity. (Sina Pharmaceutical News)

Part 3 Pharmaceutical News

Roche’s ADC Drug Hercelex Approved

Roche China announced that the National Medical Products Administration has officially approved the innovative targeted drug Kadcyla® (generic name: trastuzumab emtansine) as a monotherapy for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after receiving neoadjuvant therapy based on taxanes combined with trastuzumab. (Sai Bailan)

GSK/Sanofi’s Collaboratively Developed HIV Vaccine Fails in Phase IIb/III Trial!

On the 3rd, the NIH announced that its subordinate National Institute of Allergy and Infectious Diseases had halted a clinical trial of an investigational HIV vaccine being conducted in South Africa. The reason was that the Data and Safety Monitoring Board found during an interim review that the investigational vaccine regimen did not prevent HIV infection. However, the board expressed no concerns regarding the safety of the vaccine recipients. (Sina Medical News)

Beta Pharma Out-Licenses Novel Ophthalmic Drug Vorolanib

Beta Pharma announced that its controlling subsidiary, Equinox Sciences, LLC, has entered into an Exclusive License Agreement with EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), granting EYPT the exclusive rights to develop the tyrosine kinase inhibitor Vorolanib (CM082) via local injection for the treatment of ocular diseases such as wet age-related macular degeneration. (Sina Medical News)

Northeast Pharmaceutical and Its Subsidiaries Obtain Certificates for Disinfectant Production Licenses

On the 4th, Northeast Pharmaceutical issued an announcement stating that the company and its wholly-owned subsidiary, Northeast Pharmaceutical Group Shenyang No.1 Pharmaceutical Co., Ltd., have respectively obtained the "Hygiene License for Disinfection Product Manufacturing Enterprises" issued by the Shenyang Municipal Health Commission and the "Medical Device Registration Certificate of the People's Republic of China" issued by the Liaoning Provincial Drug Administration. (Sina Medical News)

Sunpu Medical's Subsidiary Obtains Medical Device Registration Certificate

On the 4th, Hunan Yangpu, a subsidiary of Guangzhou Impro Medical, received the "Medical Device Registration Certificate" issued by the Hunan Provincial Drug Administration. It is reported that the medical surgical masks were approved through an emergency review process, with a validity period of eight months. In addition, the emergency registration for another product from Hunan Yangpu—medical protective masks—is still underway. (Sina Pharmaceutical News)

Puli Pharmaceutical’s Ganciclovir Sodium for Injection Receives Marketing Authorization in Cyprus

On the 4th, Poly Pharma announced that it had recently received notification that its registration application for 500mg Ganciclovir Sodium for Injection, submitted to the Cyprus Drug Regulatory Authority, had been approved. (Sina Pharmaceutical News)

Viagra’s Indication for “Pulmonary Arterial Hypertension” to Be Approved in China Soon

On the 3rd, the Center for Drug Evaluation (CDE) released a batch of drugs proposed for priority review and approval, including Pfizer’s “Sildenafil Citrate Tablets,” which was included on the list due to its designation as a treatment for rare diseases. It had previously been included in the list of urgently needed overseas new drugs for clinical use. (Insight Database)

Pfizer’s Tafamidis Marketing Authorization Application in China Proposed for Priority Review

On the 3rd, the CDE website showed that Pfizer's tafamidis soft capsules marketing application was included in the proposed priority review procedure under Priority Review Category (II) for four rare diseases. (Sina Pharmaceutical News)

UCB’s Cimzia Approved in Japan for Multiple Psoriasis Indications

Ucb recently announced that Japanese regulators have approved Cimzia (Chinese brand name: Ximinjia®, generic name: certolizumab pegol, certolizumab pegol injection) for the treatment of plaque psoriasis, psoriatic arthritis, pustular psoriasis, and erythrodermic psoriasis in patients who have not responded adequately to existing therapies. (Bio Valley)

Tide Pharmaceutical’s New Drug Clinical Application for Pulmonary Fibrosis Accepted by FDA

On the 3rd, China Biopharmaceuticals announced that its subsidiary, Beijing Tide Pharmaceutical, had submitted an Investigational New Drug (IND) application to the FDA for TDI01, an innovative anti-fibrotic drug independently developed by the company, and that the application had been accepted. (PharmaCube)

Hongyun Huaning’s Novel Antibody Drug GMA301 for Pulmonary Arterial Hypertension Receives FDA Clinical Trial Approval

Hongyun Huaning’s original monoclonal antibody new drug, GMA301, has recently received investigational new drug (IND) approval from the U.S. Food and Drug Administration (FDA). This marks another regulatory endorsement by a prestigious health authority following its prior approval by the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA), representing yet another milestone in Hongyun Huaning’s globalization of new drug development. (PharmaCube)

Market Launch of Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Gene Mutation Detection Kit

Recently, the National Medical Products Administration (NMPA), upon review, approved the registration of the innovative product “Human EGFR/KRAS/BRAF/HER2/ALK/ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing Method)” produced by Xiamen Feishuo Biotechnology Co., Ltd. (Sina Pharmaceutical News)