Jiangsu Releases COVID-19 Vaccine Procurement List; Merck Sells Moderna Stake

[December 3, 2020 / Pharmaceutical News Brief] CDE Accepts BMS’s Marketing Application for a New Indication of Opdivo; Merck & Co. Divests Its Stake in Moderna; Hengrui Medicine Receives Approval for Clinical Trials of Norliglutide Injection; CSPC Pharmaceutical Group’s “First-in-Class” Antibody Drug Approved for Clinical Trials in China; Lepu Medical Spins Off for Listing... Stay tuned with Sudushe for the latest daily pharmaceutical and medical news!

Part 1 Policy Brief

Two Ministries Issue Document to Deepen Reform of the Professional Title System for Medical and Nursing Staff

On December 1, the Ministry of Human Resources and Social Security and the National Health Commission jointly released the “Guiding Opinions on Deepening the Reform of the Professional Title System for Health Professionals (Draft for Comment),” which was researched and drafted by the two departments. The reform focuses on addressing issues in the previous evaluation criteria, such as excessive emphasis on academic papers, insufficient practical orientation, and inadequate attention to clinical practice. (Ministry of Human Resources and Social Security)

Jiangsu Releases Procurement Catalog for COVID-19 Vaccines

On December 1, the Jiangsu Provincial Public Resource Trading Center issued the “Notice on Carrying Out Procurement of Novel Coronavirus Vaccines.” The procurement catalog indicates that all COVID-19 vaccines procured by Jiangsu this time are inactivated novel coronavirus vaccines (Vero cell) approved for emergency use, supplied respectively by Wuhan Institute of Biological Products Co., Ltd., Beijing Sinovac Biotech Co., Ltd., and Beijing Institute of Biological Products Co., Ltd. (Jiangsu Provincial Public Resource Trading Center)

Heilongjiang Removes Distance Restrictions for Pharmacies

On December 1, the Heilongjiang Provincial Medical Products Administration issued the "Notice on Optimizing the Approval Procedures for the Establishment of Drug Operation (Retail) Enterprises." The Notice clarifies that the approval process for establishing drug operation (retail) licenses will be optimized by abolishing the preparatory approval requirements for retail chain outlets and retail drug enterprises. A notification-and-commitment system shall be implemented for the approval of applications to establish retail chain outlets and retail drug enterprises that exclusively deal in Class B over-the-counter drugs. Unreasonable conditions, such as setting distance restrictions between pharmacies, shall not be imposed on the establishment of drugstores. (Heilongjiang Provincial Medical Products Administration)

Guixi, Jiangxi: Comprehensive Resolution of Rural Doctor Issues

On December 1, the General Office of the People's Government of Guixi City, Jiangxi Province, issued the "Notice on Printing and Distributing the Implementation Measures (Trial) for the 'Township Recruitment and Village Deployment' of Village Doctors in Guixi City." The Measures systematically stipulate provisions regarding talent selection, compensation and benefits, and the management of village clinics for the village doctor profession. (People's Government of Guixi City, Jiangxi Province)

Hainan Launches Province-wide Pilot Program for Medical Device Coding

Recently, the Hainan Provincial Medical Products Administration issued the “Work Plan for the Pilot Implementation of the Unique Device Identification System in Hainan Province,” indicating that it will explore the pilot application of unique device identifiers across various stages including medical device production, distribution, and use. The administration aims to promptly summarize experiences, establish operational standards and work procedures, and replicate and promote these practices to expand the scope of the pilot program. (Hainan Provincial Medical Products Administration)

Part 2 Industry Observation

AbbVie Secures $1 Billion R&D Collaboration

AbbVie and Frontier Medicines Announce Global Strategic Collaboration to Discover, Develop, and Commercialize Novel Small-Molecule Drugs Targeting “Undruggable” Proteins Using Frontier’s Proprietary Chemoproteomics Platform (WuXi AppTec)

Merck & Co. Dumps Moderna Shares

On December 2, Merck & Co. issued a statement announcing that it had divested its direct equity stake in Moderna during the first half of the fourth quarter of this year by selling its shares in the company, which would result in “a slight increase in financial revenue for the fourth quarter.” The value of the proceeds has not been disclosed but may be significant. (Sina Medical News)

Johnson & Johnson Acquires Hemera's Gene Therapy

Recently, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, acquired the patent rights to Hemera Biosciences’ gene therapy. Neither party disclosed specific financial details regarding the acquisition. The HMR59 therapy is currently in Phase I clinical development and is undergoing Phase II evaluation within its Phase I trial for patients with wet age-related macular degeneration (AMD). (Sina Medical News)

Tallac Completes $62 Million Series A Financing

On December 1, Tallac Therapeutics announced the completion of a $62 million Series A financing round, primarily to advance the development of multiple solid tumor candidate drugs identified through its novel Toll-like receptor agonist-antibody conjugate platform. (PharmCube)

STA Pharma, WuXi Biologics, and Tubulis Announce Collaboration

On December 2, WuXi AppTec’s subsidiary STA Pharmaceuticals, WuXi Biologics, and Tubulis announced the establishment of a strategic partnership to jointly accelerate the development of Tubulis’ next-generation antibody-drug conjugates (ADCs) up to the submission of an Investigational New Drug (IND) application. (Yi Yao Guan Lan)

Lepu Medical Spin-off Listing

On December 1, Lepu Medical’s subsidiary, Lepu Diagnostics, officially released its prospectus. On November 2, Lepu Medical had announced that it planned to spin off Lepu Diagnostics for listing on the STAR Market of the Shanghai Stock Exchange. (Sai Bailan Medical Devices)

Guoda Pharmacy’s First Beauty Store Opens in Shanghai

Recently, Guoda Drugstore launched its first new retail pharmacy featuring European/American and Japanese/Korean cosmetics at the Zhangyang Store in Pudong New Area, Shanghai. Currently, Guoda’s new retail cosmetic pharmacies have reached a total of 22 stores, distributed across various commercial districts in Shanghai. (Pharmacy Manager)

Huadao Biology Completes Nearly 200 Million Yuan in Series C Financing

Huadao Biology Completes Nearly RMB 200 Million in Series C Financing (Yigu)Recently, Huadao Biology completed a Series C financing round of nearly RMB 200 million. The funds will be primarily used for the construction of Phase I of Huadao Biology’s Songjiang base and to complete the Phase I clinical trial of its HD CD19 CAR-T injection.

Part 3 Pharmaceutical News

CDE Accepts New Indication Marketing Applications for Bristol Myers Squibb’s Opdivo and Yervoy

Today, the latest public notice on the CDE website announced that the marketing application for new indications of Bristol-Myers Squibb’s immune checkpoint inhibitors nivolumab and ipilimumab has been accepted. One week ago, the combination therapy of these two drugs was proposed to be included in the priority review as “drugs eligible for conditional approval,” intended for the treatment of adult patients with previously untreated unresectable non-epithelioid malignant pleural mesothelioma. (Yiyao Guanlan)

Bayer Launches Cell and Gene Therapy Platform

Bayer Announces Launch of Cell and Gene Therapy Platform by Its Pharmaceuticals Division, Further Solidifying Its Nascent Leadership in the Field to Better Advance the Development of Cell and Gene Therapies (Sina Medical News)

Approval Granted for Clinical Trial of Hengrui's Noritoglycopeptide Injection

Today, Hengrui Medicine announced that it had recently received the "Notice of Approval for Drug Clinical Trials" issued by the National Medical Products Administration (NMPA) for Nolitide Injection, and will commence clinical trials in the near future. Nolitide Injection is intended for the treatment of obesity or overweight. (Sina Pharmaceutical News)

Qilu Pharmaceutical’s Dabigatran Etexilate Capsules Approved for Market Launch

On December 2, data from the official website of the Center for Drug Evaluation (CDE) showed that Qilu Pharmaceutical’s Class 4 generic marketing application for dabigatran etexilate capsules was accepted. In 2019, sales of this drug at the terminal end of public medical institutions in China exceeded RMB 600 million. (Menet Network)

CSPC Pharmaceutical Group’s “First-in-Class” Novel Antibody Drug Approved for Clinical Trials in China

On December 1, CSPC Pharmaceutical Group announced that the clinical trial application for its subsidiary’s Class 1 new drug, ALMB-0166, had been approved by the National Medical Products Administration (NMPA) to conduct clinical studies in acute spinal cord injury. ALMB-0166 is a first-in-class humanized monoclonal antibody inhibitor targeting the hemichannel membrane protein Connexin 43. (Yiyao Guanlan)

Haisco's Class 1 New Drug Is About to Be Approved

Recently, Haisco’s marketing application for its Class 1 new drug, HSK3486 emulsion injection, has entered the approval review stage and is expected to be approved for market launch soon. The indication anticipated for approval is sedation and/or anesthesia for diagnostic and therapeutic gastrointestinal endoscopy. (Menet)