Dandelion Bio·News | Top Headlines in Biopharma (Sep 25 – Oct 8)
Juventas
Innovative Cell Therapy Drug Developer
Genmab
Differentiated Antibody Therapy Developer
Merus
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1. NMPA | Commercial-scale batches of drugs approved overseas can be imported and sold before domestic approval
2025Year: September 30,The National Medical Products Administration (NMPA) releasedAnnouncement of the National Medical Products Administration on the Import of Commercial-Scale Batches of Drugs Approved Overseas Before Approval in China. The Announcement clarifies that after overseas-approved drugs are approved for marketing in China (including obtaining drug approval documents or supplementary application approval documents), commercial-scale batches produced before approval that meet the requirements will be allowed to be imported and marketed in China.
There are six applicable categories of drugs, including original research drugs, improved new drugs, drugs for shortages, drugs for rare disease treatment, and other clinically urgently needed drugs, as well as drugs approved for marketing in China under the expedited drug registration and approval procedures stipulated in the "Regulations on Drug Registration."(Click here for related reading)
(Source: National Medical Products Administration）
2、CDE | Release multiple drafts for public comment
2025Year: September 26-29，CDEReleased multiple draft solicitations for comments:
Technical Guidelines for Clinical Evaluation of Drug Marketing Applications (Draft for Comments)
Technical Guidelines for Clinical Evaluation of Drug Clinical Trial Applications (Draft for Comments)、
ICH "Q3E: Guideline for Extractables and Leachables" draft guideline and its supporting documents.
(Source: National Medical Products AdministrationCenter for Drug Evaluation）
Affected
Reason
Affection
Situation
CDE Acceptance Status
September 25, 2025From October 1 to October 8, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of ChinaA total of 440 drugs were acceptedIndividual, among whichBiological Products 96Individual（New Drug 44Individual and Imported 11Individual）。
Enterprise
Industry
Move
State
1. Juventas | CAR-T Drug IND Application Accepted
2025On October 9, Juventas' independently developed innovative productHY001N Cell InjectionTheInvestigational New Drug Application (IND)Has been officially accepted for public review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), intended for the treatment ofHaving failed at least three lines of treatmentAutoimmune Hemolytic Anemia(Autoimmune Hemolytic Anemia, AIHA) patients.
(Source: Juventas Official WeChat)）
2025YearOn September 29, Danish biotech giant Genmab Announce that it will be approximately 80 Acquisition of Dutch Innovative Antibody Company for $ Billion in Cash Merus N.V.. This transaction not only set a new record for high-value acquisitions in the European biotech field but also marked GenmabIn the process of“Collaboration-Driven”To“Self-innovative Type”Transformation of Pharmaceutical Enterprises.
(Source:GenmabOfficial Website, PharmaDJ）
2025YearSeptember28th,China Biologics announced on its official WeChat account,China National Pharmaceutical Group's Chengdu Institute of Biological Products and China Biological Research Institute jointly applied for a quadrivalent recombinant human papillomavirus vaccineMiao (Hansenula, Trade Name "Aivijia”) approved for marketing (CXSS2400063).“Aivijia"Is the first domestically produced quadrivalent HPV vaccine approved for marketing in China", covering four HPV subtypes: 6, 11, 16, and 18Among them, HPV16/18 are the main high-risk types of viruses that cause cervical cancer, while HPV6/11 are closely related to low-risk infections such as genital warts.
(Source: China Biologic Official WeChat)）
2025On September 27, Keyi Pharmaceuticals announced a strategic partnership with U.S.-based biopharmaceutical company VRise Therapeutics ("VRise").The two parties signed an exclusive licensing agreement for the Indian region regarding KQ-2003, a globally first-in-class dual-targeted CAR-T cell therapy product (targeting BCMA/CD19) independently developed by Keyi Pharmaceuticals. VRise will obtain exclusive rights to develop, register, and commercialize the product in the Indian region.In addition to developing the indication for relapsed/refractory multiple myeloma, Vrise also plans to explore the clinical and commercial potential of KQ-2003 in treating autoimmune diseases in the Indian region.
(Source:Keyi PharmaceuticalsOfficial Weibo）
(Source: Dandelion Ouryao）
Editor: Sesame Walnut
Statement:This article only represents the author's personal views and does not represent the position of any organization or this official account. If there are any inappropriate points, please correct them. If you need to reprint, please indicate the author and source:蒲公英Biopharma.
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