Novartis to Integrate Business Units and May Cut Thousands of Jobs

[April 15, 2022/Medical News Overview] China's National Medical Products Administration issued the "Guiding Principles for Pharmacovigilance Inspections"; Wantai Bio’s Q1 2022 net profit reached 1.331 billion yuan, a year-on-year increase of 360.18%; Gene-edited B cells secure $130 million to advance new cell therapy types... For the latest daily pharmaceutical news and medical updates, follow Speed Reading Society!

Policy Brief

NMPA Issues Guiding Principles for Pharmacovigilance Inspections

On the 15th, the National Medical Products Administration issued the "Guiding Principles for Pharmacovigilance Inspections" to implement the requirements of the "Drug Administration Law of the People's Republic of China" and the "Vaccine Administration Law of the People's Republic of China" regarding the establishment of a pharmacovigilance system, and to guide drug regulatory authorities in scientifically and standardly conducting pharmacovigilance inspections. (National Medical Products Administration)

NMPA Announces 116 Medical Device Industry Standards for Revision in 2022

On the 14th, the General Office of the National Medical Products Administration announced that, in accordance with the requirements of the "Measures for the Administration of Medical Device Standards" and the "Management Regulations for the Revision of Medical Device Standards", the National Medical Products Administration organized the selection of projects for the formulation and revision of medical device industry standards in 2022. After soliciting public opinions and organizing expert consultations, 116 projects for the formulation and revision of medical device industry standards in 2022 were determined and are now being made public. (General Office of the National Medical Products Administration)

Industry Observation

Novartis Business Unit Integration May Lead to Thousands of Layoffs

Recently, Novartis CEO Vas Narasimhan announced the integration of multiple business units to streamline the structure, promote growth, and cut costs. According to the Swiss newspaper *Tages-Anzeiger*, as part of this restructuring plan, Novartis will lay off thousands of employees worldwide. As of the end of 2021, Novartis had 41,280 sales and marketing employees, approximately 12,800 operational staff, and 4,727 general and administrative employees. Based on Novartis’ plans, these areas are likely to be the most affected by layoffs. (Sina Medicine News)

Wantai Bio appoints Xie Bo as Board Secretary

On the 15th, Wantai Bio announced that the board of directors agreed to appoint Xie Bo as the board secretary. The term of office will last from the date of approval by this board of directors until the end of the term of the fifth board of directors. (Corporate Announcement)

Stephenson Pharmaceutical Transfers 1% Stake in Sichang Pharmaceutical to Beijing Si Huan Pharmaceutical

On the 14th, Buchang Pharmaceutical transferred 1% of its shares in Sichang Pharmaceutical to Beijing SiHuan Pharmaceutical. Before the share transfer, Sichang Pharmaceutical was held 50% by Buchang Pharmaceutical and 50% by Beijing SiHuan Pharmaceutical; after the share transfer, Buchang Pharmaceutical holds 49%, and Beijing SiHuan Pharmaceutical holds 51%. In addition, there were changes in key members of Sichang Pharmaceutical: Liu Jun exited as a director, Liu Luxiang exited as a director, Wang Minggeng was newly appointed as vice chairman, and Qi Yankun as a director. (Corporate Announcement)

Wantai Bio 2022 Q1 Net Profit of 1.331 Billion Yuan, Up 360.18% Year-on-Year

On the 15th, Wantai Bio released its Q1 2022 report. The company achieved operating revenue of 3.171 billion yuan, a year-on-year increase of 284.85%; net profit attributable to shareholders was 1.331 billion yuan, a year-on-year increase of 360.18%; non-recurring net profit was 1.315 billion yuan, a year-on-year increase of 367.75%; basic earnings per share were 2.19 yuan. (Corporate Announcement)

Gene-Edited B Cells: $130 Million Boost for Developing New Cell Therapy Types

Be Biopharma Announces $130 Million Financing to Advance Proprietary Autologous and Allogeneic Engineered B Cell Medicine Platforms Across Multiple Therapeutic Areas and Progress Pipeline Candidates into Clinical Development (WuXi AppTec)

Pharmaceutical News and Medical Information

Pfizer's JAK Inhibitor Tofacitinib Tablet Receives New Indication Approval in China

Today, the NMPA official website announced that the new indication marketing application for Pfizer's Tofacitinib Citrate Tablets has been approved. Public information shows that Tofacitinib is a JAK inhibitor, which has been approved by the U.S. FDA for multiple indications. In China, Tofacitinib was first approved in 2017, and currently, the drug is undergoing clinical trials for at least 17 diseases. The specific indication for this approval has not been disclosed in public information. (NMPA)

Bristol-Myers Squibb's Breyanzi Approved in the EU

Recently, Bristol-Myers Squibb announced that the European Commission has approved the CD19 CAR-T cell therapy Breyanzi for the treatment of large B-cell lymphoma, specifically for adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, and grade 3B follicular lymphoma who have received two or more prior lines of systemic therapy. (Bioon.com)

Regeneron's COVID-19 Therapy BLA for Pre-Exposure Prophylaxis Delayed by US FDA

Recently, Regeneron stated that the US FDA has extended the review period for the Biologics License Application (BLA) of REGEN-COV, used for treating non-hospitalized patients with COVID-19 and as a preventive measure for certain individuals, by three months to July 13. Previously, REGEN-COV had been put on hold in the United States due to Omicron, and now the drug is also encountering issues while seeking full approval from the US FDA. (Sina Medicine News)

FDA Approves First Device to Detect COVID-19 Using Breath Samples

On the 14th, the U.S. FDA issued the first Emergency Use Authorization (EUA) for a COVID-19 diagnostic tester, which can detect compounds in breath samples associated with SARS-CoV-2 infection. It is used in settings where patient samples are collected and analyzed, such as doctors' offices, hospitals, and mobile testing sites, using an instrument about the size of carry-on luggage. This must be performed by qualified, trained operators under the supervision of healthcare providers authorized or licensed by state law to conduct tests, and results can be obtained within 3 minutes. (Medicine Cube)

Merck's 21-Valent Pneumococcal Vaccine Granted FDA Breakthrough Therapy Designation

On the 14th, Merck announced that the FDA granted its investigational 21-valent pneumococcal vaccine V116 Breakthrough Therapy designation for the prevention of pneumococcal infections and bacterial pneumonia in adults aged 18 years and older. (PharmaCube)

BGI's Wholly-Owned Subsidiary's Thalassemia Gene Detection Product Obtains Medical Device Registration Certificate

On the 15th, BGI Group announced that its wholly-owned subsidiary, BGI Biotechnology (Wuhan) Co., Ltd., had recently obtained a medical device registration certificate from the National Medical Products Administration for its α and β Thalassemia Gene Detection Kit (Combinatorial Probe-Anchor Polymerization Sequencing Method). (Corporate Announcement)

First Generic! Yangtze River Pharmaceutical's Sugammadex Sodium Approved for Marketing

On the 15th, the National Medical Products Administration (NMPA) approved the marketing application for the generic version of Sugammadex Sodium, indicating that this blockbuster product, worth $1.5 billion, has finally welcomed its first generic version in China. Sugammadex Sodium is the world's first selective muscle relaxant antagonist used to reverse neuromuscular blocking agents. In clinical surgical anesthesia, it can help patients under general anesthesia to precisely and quickly reverse deep and moderate muscle relaxation states, promoting the recovery of spontaneous breathing and limb movement abilities, and helping to improve patients' postoperative outcomes. (National Medical Products Administration)

Shandong New Era Metformin Hydrochloride Extended-Release Tablets Approved for Marketing

On the 15th, NMPA released the latest drug approval information, and Shandong New Era Pharmaceutical's metformin hydrochloride extended-release tablets, a Category 4 generic drug, was approved for marketing. In recent years, Shandong New Era Pharmaceutical has been increasing its focus on the diabetes medication field. The company’s first insulin product, recombinant insulin glargine injection, has been submitted for production and is currently under review. (NMPA)

China Resources Tianqing submits marketing application for Palbociclib Capsules

On the 14th, Chia Tai Tianqing Pharmaceutical Group submitted a Class 4 generic listing application for Palbociclib Capsules. Palbociclib is an anti-tumor drug with global sales exceeding 5 billion US dollars from Pfizer. Qilu took the lead in producing the first generic version in China in December 2020. Palbociclib was originally developed by Pfizer and is the world's first marketed CDK4/6 inhibitor. (Source: Menet)

Bio-Thera's BAT8009 for Injection Receives Clinical Trial Approval Notice

On the 15th, Bio-Thera Solutions announced that the company had recently received the "Clinical Trial Approval Notice" issued by the National Medical Products Administration for the investigational drug BAT8009 for injection. BAT8009 is an antibody-drug conjugate targeting B7H3 developed by Bio-Thera Solutions and is intended for the treatment of solid tumors. B7H3 (also known as CD276) is a membrane protein member of the B7 family of immune regulatory proteins, highly expressed in various solid tumors, playing a role in multiple processes such as tumorigenesis, development, and immune escape, and is associated with poor tumor prognosis. (Corporate Announcement)

Treatment of Large B-Cell Lymphoma: AbbVie/Genmab Bispecific Antibody Succeeds in Mid-Stage Trial

Recently, AbbVie and Genmab announced positive topline results from the Phase I/II Epcore NHL-1 trial of the investigational antibody therapy epcoritamab for relapsed and refractory large B-cell lymphoma. According to observations by the Independent Review Committee, the therapy demonstrated an overall response rate of 63.1% in the trial, with a median duration of response lasting up to 12 months. (Sina Medicine News)

The World's Only IL-27 Monoclonal Antibody in Research Enters Phase II Clinical Trials

On the 14th, Surface Oncology announced the launch of two Phase II clinical trials for the first-in-class monoclonal antibody drug SRF388. SRF388 is currently the world's only IL-27-targeted drug in clinical development and the first IL-27 monoclonal antibody to enter the Phase II proof-of-concept stage. (PharmaCube)

Huadong Medicine "Olaparib" Initiates Clinical Trials

On the 14th, Huadong Medicine launched the BE trial of PARP inhibitor "Olaparib", becoming the fourth company in China to join the competition for the generic version of this blockbuster drug. (PharmaCube)

Hengrui Celebrates Double Joy! One Injectable Approved, Another ANDA Number Obtained

On the 15th, the NMPA official website showed that Jiangsu Hengrui Medicine's medium and long chain fat emulsion/amino acids (16)/glucose (16%) injection was approved (Approval No. H20223219); on the same day, the company announced that the abbreviated new drug application (ANDA) for gadoterate meglumine injection had been approved. (NMPA, corporate announcement)

NMPA Announces the Acceptance of Fuganlin Oral Liquid for Traditional Chinese Medicine Protection

On the 14th, the National Medical Products Administration released information on the acceptance of traditional Chinese medicine variety protection. The announcement showed that the accepted traditional Chinese medicine variety is Fuganling Oral Liquid from Yipinhong Pharmaceutical, and the application matter is a supplementary application. (National Medical Products Administration)