Pharma News Weekly Recap (March 2–8, 2026): Regulatory Updates, Major Deals, and New Drug Applications

(Source:BaiCheng Pharmaceuticals）

【Pharma News Medical Information】Weekly Overview】Notice on Publicly Soliciting Opinions on the "Technical Guidelines for Clinical Trials of Preventive mRNA Vaccines (Draft for Comments)"$1.18 Billion! UCB Acquires Global Rights of CD19/CD3 Bispecific Antibody from Antengene; Semaglutide's Fifth Indication for MASH Submitted for Marketing Approval in China…

Policy Brief

CountryNotice of the Center for Drug Evaluation of the National Medical Products Administration on the Release of "Considerations for Selecting Subject Populations in Bioequivalence and Pharmacokinetic Comparative Studies of Anticancer Drugs" (No. 22, 2026)）

Different types of anti-tumor drugs carry different safety risks, and considerations for selecting participants also vary. On March 5, in order to guide the selection of participant populations for bioequivalence and pharmacokinetic comparison studies of anti-tumor drugs, the Center for Drug Evaluation, under the arrangement of the National Medical Products Administration (NMPA), formulated the "Considerations for Participant Population Selection in Bioequivalence and Pharmacokinetic Comparison Studies of Anti-Tumor Drugs." In accordance with the requirements of the "Notice of the General Office of the National Medical Products Administration on Issuing the Procedures for the Release of Pharmaceutical Technical Guidelines" (No. 9 [2020] of the NMPA's Comprehensive Drug Management), and after review and approval by the National Medical Products Administration,Released. (CDE)

Notice on Publicly Soliciting Opinions on the "Technical Guidelines for Clinical Trials of Preventive mRNA Vaccines (Draft for Comments)"

On March 4, in order to standardize and guide clinical trials for preventive mRNA vaccines, the Center for Drug Evaluation under the National Medical Products Administration drafted the "Technical Guiding Principles for Clinical Trials of Preventive mRNA Vaccines (Draft for Public Comment)" based on extensive research and discussions, combined with relevant guidelines and technical requirements both domestically and internationally, as well as current technological advancements and scientific understanding. The draft is now open for public comments.（CDE）

Industry Economy Observation

$1.18 Billion! UCB Acquires Global Rights to Antengene's CD19/CD3 Bispecific Antibody

On March 4, ANTENGENE CORPORATION announced that it has signed an agreement with UCB. ANTENGENE CORPORATION will grant UCB the exclusive rights to develop, manufacture, and commercialize ATG-201, a CD19/CD3 bispecific T-cell engager antibody, globally, including the authorization of production technology related to ATG-201. (Medaverse)）

Over $1.5 Billion! Sino Biopharm's FIC Drug Licensed to Sanofi

On March 4, Sino Biopharm announced an exclusive licensing agreement with Sanofi for Rovaseltinib, with a total amount of up to $1.53 billion. Rovaseltinib is a global first-in-class oral small molecule JAK/ROCK inhibitor, which has previously been approved for marketing by the regulatory authority. (Insight Database)）

Leman Biotech Completes Nearly 200 Million Yuan in Additional Series A Financing, Pioneering Disruptive Immune Cell Therapy with Metabolic Reprogramming Technology

On March 4, Leman Biotech Co., Ltd. announced the completion of a nearly 200 million yuan Series A+ financing round. This round was led by Yuecai Zhongyin, an institution under Yuecai Holdings, and XtalPi, with participation from Kuangshi Zhixing, Mony Valley, Tylon Investment, Zhongshan Venture Capital, as well as individual financial investors. Existing shareholder Fuhui Venture Capital continued to increase its investment. (PharmaCube)）

Pharmaceutical News and Medical Information

Treatment for MASH! The Fifth Indication of "Semaglutide" Submitted for Market Approval in China

On March 3, the official website of the Center for Drug Evaluation (CDE) under the National Medical Products Administration announced that the new indication application for Novo Nordisk's key drug, semaglutide injection, has been accepted and is proposed for priority review. According to the announcement, the indication applied for is the treatment of non-cirrhotic adult patients with metabolic dysfunction-associated steatohepatitis (MASH) accompanied by moderate to severe hepatic fibrosis. (Source: PharmaDJ)）

Bayer Retains Rights to a Pompe Disease AAV Gene Therapy, Belief Biomed Involved in Development

On March 4, Bayer confirmed in its Q4 2025 earnings report that it has officially terminated the development of ACTUS-101, its early-stage gene therapy for Pompe disease, and will focus resources on advancing another similar investigational drug, AB-1009. (MedInnovation)）

Xiwedal/Pfizer's Biased Long-Acting GLP-1 New Indication Approved for Marketing

On March 6, Sciwind Biosciences and Pfizer announced that the new indication of their cAMP-biased GLP-1 receptor agonist "Ecnoglutide" has been approved for marketing in China, intended for long-term weight management in adult patients based on controlled diet and increased physical activity. (Insight Database)）