Novartis Submits Erenumab for Marketing Approval in China as JD Health Announces Board Changes

[April 8, 2022/Medical News at a Glance] The proposed and alternative results of the Guangdong Alliance's centralized bulk procurement of traditional Chinese medicines such as Qingkailing have been announced; Starting from April 9, the price for individual nucleic acid testing in Beijing will be reduced to 24.9 yuan; Pfizer plans to spend $525 million to acquire a respiratory syncytial virus therapy to expand its infectious disease pipeline... For the latest pharmaceutical news and medical information, Speed Reading Society is here to keep you updated!

Policy Brief

Ten Departments Jointly Issue the "14th Five-Year Plan" Action Plan for Enhancing the Capacity of Grassroots Traditional Chinese Medicine Services

On the 7th, the official website of the National Medical Security Administration showed that ten departments, including the National Administration of Traditional Chinese Medicine, the National Health Commission, and the National Medical Products Administration, jointly issued the "14th Five-Year Plan for the Action to Enhance the Capacity of Grassroots Traditional Chinese Medicine Services." The specific goals are as follows: By 2025, grassroots traditional Chinese medicine will achieve five "full coverages": ① County-level TCM medical institutions (hospitals, outpatient departments, clinics) will basically achieve full coverage, with over 80% of county-level TCM hospitals reaching the level of "Class A Grade II TCM Hospital"; ② Full coverage of TCM halls at community health service centers and township health centers, encouraging places with conditions to complete service connotation construction for 15% of TCM halls at community health service centers and township health centers; ③ Provision of grassroots TCM services will basically achieve full coverage, with 100% of community health service centers and township health centers being able to standardly carry out more than 10 appropriate TCM technologies, and 100% of community health service stations and over 80% of village clinics being able to standardly carry out more than 6 appropriate TCM technologies; ④ Equipping grassroots TCM talents will basically achieve full coverage, with the proportion of TCM category physicians in community health service centers and township health centers exceeding 25% of the total number of physicians in similar institutions, and 100% of community health service stations and over 80% of village clinics being equipped with at least one medical staff member who can provide TCM services; ⑤ Full coverage of grassroots TCM health education, with all county-level regions establishing TCM health education bases relying on county-level hospitals to promote the popularization of TCM health knowledge. (National Medical Security Administration)

Publication of the Proposed Winning/Alternative Results for the Guangdong Alliance's Centralized Volume-based Procurement of Traditional Chinese Medicine Products like Qingkailing

Today, the Guangdong Province Pharmaceutical Trading Center released a notice regarding the public announcement of the proposed winning/bid results for the centralized bulk procurement of traditional Chinese medicines such as Qingkailing in the Guangdong Alliance. The announcement period is from April 8, 2022, to 17:00 on April 12, 2022. (Guangdong Province Pharmaceutical Trading Center)

The Price of Single COVID-19 Nucleic Acid Test in Beijing Drops to 24.9 Yuan Starting from April 9

Recently, the Beijing Municipal Medical Security Bureau, together with the Beijing Municipal Health Commission, the Beijing Municipal Finance Bureau, and the Beijing Municipal Human Resources and Social Security Bureau, issued the "Notice on Reducing the Price of COVID-19 Nucleic Acid Testing Projects." Starting from April 9, the price for single-sample COVID-19 nucleic acid testing at public medical institutions in Beijing will be reduced from 35 yuan per test to 24.9 yuan, and the price for mixed-sample testing will be simultaneously reduced from 8 yuan per sample to 5.9 yuan. (Beijing Municipal Medical Security Bureau et al.)

Tianjin: Implementation of the National Organized Artificial Joint Centralized Volume Procurement and Usage Work

On the 8th, the Tianjin Medical Procurement Center released the "Notice on Implementing the National Organization's Artificial Joint Procurement and Usage Work." The notice provides specific plans and requirements for procurement categories, agreed procurement volumes, procurement cycles, and key tasks. (Tianjin Medical Procurement Center)

Industry Economics Observation

CARsgen Pharma Appoints Raffaele Baffa as Chief Medical Officer

On the 8th, CARsgen Therapeutics announced the appointment of Dr. Raffaele Baffa as the company's Chief Medical Officer (CMO). Dr. Baffa will be responsible for leading the global clinical development strategy and operations of the company’s innovative pipeline candidates, reporting to Dr. Zonghai Li, founder, chairman of the board, chief executive officer, and chief scientific officer of CARsgen Therapeutics. (Sina Medicine News)

JD Health Board Changes: Xu Lei, Xin Lijun, and Xu Ran Resign as Non-Executive Directors

On July 7, JD Health announced changes in its board of directors. 1. Xu Lei has resigned as a non-executive director; 2. Xin Lijun has resigned as a non-executive director; 3. Xu Ran has resigned as a non-executive director and as a member of the Audit Committee and Remuneration Committee; 4. Wu Ying has been appointed as an independent non-executive director and as a member of the Remuneration Committee and Nomination Committee; 5. Jin Enlin has been appointed as a member of the Remuneration Committee; 6. Li Ling has resigned as a member of the Nomination Committee, transferred from being a member of the Remuneration Committee to become its Chairperson, and has been appointed as a member of the Audit Committee; 7. Chen Xingyao has resigned as the Chairperson of the Remuneration Committee. (Corporate Announcement)

Gao Xiaoming and Kou Zhihua Serve as Senior Executives of Advaccine Biopharmaceuticals

On the 8th, Advaccine Biopharmaceuticals announced that the company has recently appointed Dr. Gao Xiaoming as the Dean of the company's Science Research Institute and Vice President of the Group, and appointed Dr. Kou Zhihua as the Deputy Dean of the company's Science Research Institute.

Pfizer Plans to Spend $525 Million to Acquire Respiratory Syncytial Virus Therapy, Expanding Infectious Disease Pipeline

Pfizer and ReViral Announce Agreement for Pfizer to Acquire ReViralPfizer and ReViral today announced that they have reached an agreement under which Pfizer will acquire ReViral, a company focused on the discovery and development of novel antiviral therapies targeting respiratory syncytial virus (RSV). ReViral’s lead candidate therapy, sisunatovir, is currently being evaluated in Phase 2 clinical trials. Under the terms of the agreement, Pfizer will acquire ReViral, with total payments, including upfront and development milestone payments, potentially reaching up to $525 million. (WuXi AppTec)

TRIANA Completes $110 Million Financing to Advance Rational Design of Molecular Glues

TRIANA Biomedicines Announces $110 Million Financing to Build Potential "Best-in-Class" Scalable Technology Platform for the Discovery and Development of Molecular Glues. The TRIANA platform aims to generate products that stabilize pre-existing interactions between two proteins or create new interactions, altering the fate or function of disease targets. Molecular glues may enable the development of highly disease-relevant "undruggable" targets or those not adequately addressed by traditional drug discovery methods. (WuXi AppTec)

New锐 Receives $180 Million Boost for Longevity Research

Recently, Retro Biosciences emerged from stealth mode and announced the completion of a $180 million financing round. According to the company’s official website, Retro’s goal is to extend healthy human lifespan by 10 years! The funds obtained from this financing round will support the company in completing its proof-of-concept. (WuXi AppTec)

Pharmaceutical News and Medical Information

U.S. Medicare Explicitly Restricts Biogen's Alzheimer's Drug to Clinical Trial Patients

Recently, Biogen's highly controversial Alzheimer's drug Aduhelm (aducanumab) has faced another regulatory setback. The U.S. government has officially announced that the coverage of Aduhelm under Medicare will be strictly limited to patients participating in clinical trials. (Sina Medicine News)

Appeal Successful! Pfizer/Merck Persuades UK NICE to Support Bavencio for Bladder Cancer Treatment

Latest News: Pfizer and Merck Successfully Persuade NICE to Reverse Previous DecisionRecent developments reveal that Pfizer and Merck have successfully persuaded the UK's National Institute for Health and Care Excellence (NICE) to overturn a prior decision. The agency has recently announced that Bavencio will be included in the coverage of the UK’s standard NHS insurance. In the future, bladder cancer patients in the UK who do not show treatment progress after platinum-based chemotherapy can opt for Bavencio as a first-line maintenance therapy. (Sina Medicine News)

China Resources Double Crane's Zoledronic Acid Concentrated Solution for Injection Approved for Marketing

On the 6th, the official website of the National Medical Products Administration showed that the concentrated solution for injection of zoledronic acid reported by China Resources Double-Crane with a generic version of category 4 has been approved for marketing. Data from the MiNe Network shows that the sales revenue of zoledronic acid injections in China's public medical institutions exceeded 1.8 billion yuan in 2020. (National Medical Products Administration)

TEYI Pharmaceutical's Ethambutol Hydrochloride Tablets Pass Generic Drug Consistency Evaluation

On the 8th, Teiyi Pharmaceutical announced that the company had recently received the "Drug Supplemental Application Approval Notice" for "Ethambutol Hydrochloride Tablets" issued by the National Medical Products Administration. After review, the above-mentioned drug has passed the quality and efficacy consistency evaluation of chemical generic drugs. (Corporate Announcement)

Hengxing Pharmaceutical Levofloxacin Injection Enters Administrative Approval Stage

Recently, the official website of the National Medical Products Administration showed that the levofloxacin injection reported for production by Anhui Hengxing Pharmaceutical as a Category 3 generic drug has entered the administrative approval stage. Currently, three companies have been approved for the levofloxacin injection. Due to the impact of the generic drug market, the original research company Daiichi Sankyo previously announced the transfer of the production and sales rights of levofloxacin-related drugs in mainland China to Fosun Pharma. (National Medical Products Administration)

Heavyweight New Migraine Drug! Novartis' Erenumab Submitted for Marketing Approval in China

On the 7th, the CDE official website showed that Novartis' Erenumab injection marketing application was accepted for the prevention of migraine in adults. Erenumab is a fully human monoclonal antibody jointly developed by Amgen and Novartis to prevent migraines by blocking the activity of calcitonin gene-related peptide (CGRP). (CDE)

The First New Drug for Parkinson's Disease in Over a Decade! "Safinamide" Submitted for Market Approval in China

On the 7th, the CDE official website announced that an application for the marketing of a new drug named Safinamide Tablets (Class 5.1) has been submitted in China and accepted. Public information shows that Safinamide is a new drug for the treatment of Parkinson's disease, which was approved by the U.S. FDA in 2017, becoming the first new chemical entity approved in the United States for the treatment of Parkinson's disease in more than ten years. (CDE)

Kelun Pharma's TROP2 ADC Approved for Phase III Clinical Trial Targeting Triple-Negative Breast Cancer

On the 7th, Kelun Pharmaceuticals announced that the TROP2 antibody-drug conjugate SKB264 (TROP2-ADC) has been approved for clinical trials to treat patients with advanced or metastatic triple-negative breast cancer who have failed at least two prior lines of therapy. This randomized controlled trial will serve as the pivotal Phase III clinical trial supporting the marketing application. (Insight Database)

SciClone Pharmaceuticals Submits Small Molecule Conjugate Drug for Clinical Trial

On the 7th, the CDE official website showed that the clinical application of SaiSheng Pharmaceutical's PEN-866 Sodium for Injection was accepted by the National Medical Products Administration. PEN-866 is a Small Molecule Drug Conjugate (SMDC) developed by SaiSheng Pharmaceuticals and is currently undergoing a Phase II basket trial in the United States for solid tumors. (CDE)