Dandelion Bio·News | Weekly Highlights of China's Biopharma Industry (Feb 6–12, 2025)
Lion TCR
Developer of Novel Immunotherapies
Johnson & Johnson
Medical Device R&D and Manufacturer
Bio·News
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Supervision
Resources
News
1、NMPA | Request for Comments: Regulations on the Supervision and Administration of Production of Export Pharmaceuticals
2025On February 9, the NMPA once again solicited public opinions on the "Regulations for the Supervision and Administration of Export Drug Production (Draft for Comments)."(View related readings by clicking)
(Source: National Medical Products Administration, Ouryao）
2、CDE | Release Three Guiding Principles
2025On February 7, the CDE issued three clinical trial guidelines consecutively: "Technical Guidelines for the Preparation of Biosimilar Drug Package Inserts," "Technical Guidelines for Clinical Trials of Gene Therapy Products for Thalassemia (Trial)," and "Technical Guidelines for the Use of Patient-Reported Outcome Measures in Clinical Trials for Rheumatic and Immunological Diseases."(View related readings by clicking)
On February 9, 2025, CDE released the "Guidelines for the Review of Acceptance of Biologics Registration (Trial)".Effective from March 10, 2025。(Click to view related reading)
(Source: Center for Drug Evaluation of the National Medical Products Administration, Ouryao）
Recipient
Principle
Situation
Situation
CDE Acceptance Status
February 6, 2025From January 2 to February 12, the Center for Drug Evaluation (CDE) of the China National Medical Products AdministrationA total of 438 drugs were acceptedIndividual, among which80 Biological Products（45 new drugs and 13 imported）。
(Source: Center for Drug Evaluation, National Medical Products Administration)
Integration
Resources
Move
State
Biomedical Investment and Financing in January 2025
January 2025，29 Financing Events in China's Biomedical Enterprises; and most of them are from earlier rounds of financing, with 18 companies raising over 100 million yuan each, totaling an estimated amount exceeding 3 billion yuan.
Enterprise
Industry
Move
State
2025February 12Lion TCR announced that its mRNA-encoded TCR-T cell therapy product, Liocyx-M004, has received approval from the U.S. Food and Drug Administration (FDA) to initiate an international multicenter Phase 2 clinical trial.Liocyx-M004 is the world's first mRNA-encoded TCR-T cell therapy targeting HBV-related hepatocellular carcinoma.The international multi-center Phase 2 clinical trial approved by the FDA this time will evaluate the efficacy of Liocyx-M004 as a single agent and in combination with lenvatinib.
(Source: Official WeChat account of Laien Bio)
2、Johnson & Johnson | Two First-in-Class Bispecific Antibodies Approved for Marketing in China
2025On February 11, Johnson & Johnson announced that the marketing applications for Ryque (Amivantamab) and Talique (Taqeotamab) have been approved by the National Medical Products Administration.The former is the world's first approved EGFR/c-MET bispecific antibody, and the latter is the first approved bispecific antibody drug targeting GPRC5D.
(Source: BioShanghai)）
2025February10 days,Bio-Thera SolutionsAnnounced that it has reached an agreement with Intas Pharmaceuticals ("Intas") regardingBAT2506 (a biosimilar developed in reference to Johnson & Johnson's Simponi golimumab)Under the licensing and commercialization agreement, Intas will have exclusive commercial rights to BAT2506 in the U.S. market. Bio-Thera has already initiated the commercialization process of BAT2506 (Golimumab) injection in regions such as Europe, Asia, and Latin America.
According to the terms of the agreement, Bio-Thera will be responsible for the research and development, production, and commercial supply of BAT2506, while Intas will manage the commercialization of BAT2506 in the U.S. market through its U.S. subsidiary, Accord BioPharma. Bio-Thera is eligible to receive a total amount up to$164.5 million, including a $21 million upfront payment, cumulative milestone payments of up to $143.5 million, and a double-digit percentage of net sales as revenue sharing.
(Source: Bio-Thera)Official Weibo)
4、Henlius | CD38 Monoclonal Antibody Biosimilar Licensed to Indian Pharmaceutical Company
2025On February 6, Henlius announced that it has signed a licensing agreement with Dr. Reddy’s Laboratories SA, a wholly-owned subsidiary of Dr. Reddy’s Laboratories, for the company's self-developed investigational daratumumab biosimilar HLX15 (recombinant anti-CD38 fully human monoclonal antibody injection).
According to the terms of the agreement, Henlius will be responsible for the R&D, production, and commercial supply of HLX15, and will receive $131.6 million (approximately RMB 959 million) from the transaction, of which $33 million is the upfront payment. In addition, Henlius will also receive tiered royalties based on the product's annual net sales.
(Source: Fuhong Hanlin Official WeChat）5、Junshi Biosciences | Dual-Target Cancer Class 1 New Drug Approved for Clinical Trials in China
On February 6, 2025, Junshi Biosciences announced that toripalimab (trade name: Tuoyi), an anti-PD-1 monoclonal antibody drug independently developed by the company,®) Jointly independently developed by Mabwell (688062.SH), a Nectin-4-targeted antibody-drug conjugate (ADC) innovative drug (R&D code: 9MW2821) has recently been included in the list of breakthrough therapies by the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA).
On February 5, 2025, the CDE website disclosed that Junshi Biosciences' Class 1 new drug, AWT020 Injectable Sterile Powder, has been approved for clinical trials, intended for the treatment of advanced malignant tumors. On November 21, 2024, Junshi Biosciences announced the acquisition of rights to two bispecific fusion protein drugs for cancer treatment in Greater China for over 750 million yuan, one of which, AWT020, has already submitted a Phase I clinical trial application in China to the CDE.
(Source: Junshi Biologics Official WeChat, CDE Official Website)）
Editor: Sesame Walnut
Statement:This article only represents the author's personal views and does not reflect the position of any organization or this official account. If there are any inaccuracies, please kindly point them out. For reprints, please indicate the author and source:蒲公英Biopharma.
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