Dandelion Bio·News | Weekly Highlights in Biopharma Industry (Nov 28 – Dec 4, 2024)
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CFDI| Public Consultation: ICH "E6 (R3): Good Clinical Practice (GCP) for Drug Clinical Trials"
2024On November 29, the Inspection Center of the National Medical Products Administration released a notice regarding the public solicitation of opinions on the draft Annex 2 of ICH "E6 (R3): Good Clinical Practice (GCP)", with the deadline for comments being January 27, 2025.(View related reading by clicking)
(Source：National Medical Products AdministrationCenter for Food and Drug Inspection and Verification
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CDE Acceptance Status
November 28, 2024During the period from January to December 4, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of ChinaA total of 400 drug applications were acceptedIndividual, among which51 Biological Products（27 new drugs and 4 imports）。
(Source: Center for Drug Evaluation, National Medical Products Administration)
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2024DecemberOn the 4th, Innovent Bio and HUTCHMED(CHINA) LIMITED ("HUTCHMED") jointly announced today that Tyvyt®(Sintilimab Injection) in combination with Aiot®The New Drug Application (NDA) for (Fruquintinib) combination therapy for the treatment of patients with advanced mismatch repair proficient (pMMR) endometrial cancer who have failed prior systemic anti-tumor therapy and are not suitable for radical surgery or radical radiotherapy has been granted conditional approval by the National Medical Products Administration (NMPA) of China. Previously, this combination therapy was granted priority review and designated as a breakthrough therapy by the NMPA.This approval marks the eighth indication for Tyvyt® (sintilimab injection)., benefiting a wider range of cancer patients.
2024 YearsDecember 4, Duality Biologics (DualityBio) announced that it has entered into an exclusive licensing agreement with GSK for an antibody-drug conjugate (ADC) DB-1324.According to the agreement, GSK will obtain exclusive rights globally (excluding mainland China, Hong Kong, and Macao) to advance the research, development, and commercialization process of this ADC drug.
(Source: Denali Biotech Official WeChat)）2024On December 3, Shanghai Henlius Biotech, Inc. announced that the company's self-developed innovative anti-PD-1 monoclonal antibody H drugHANSZUMAB®(General Name: Serplulimab Injection)Officially approved by the National Medical Products Administration (NMPA) for first-line treatment in combination with pemetrexed and carboplatin for patients with locally advanced or metastatic non-squamous non-small cell lung cancer (nsNSCLC) who are EGFR gene mutation-negative and ALK-negative and are not candidates for surgical resection.This is the fifth indication approved for drug H in China, and the third indication approved in the field of lung cancer following squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC).`, is expected to bring more treatment options to a large number of lung cancer patients.`
（Source: Official WeChat account of Shanghai Henlius Biotech, Inc.)
2024On December 3, Shanghai Pharmaceutical Biologics received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration.Its declared target is CD19 and CD22 chimeric antigen receptor autologousT Cell InjectionClinical trial application for relapsed or refractory B-cell non-Hodgkin lymphoma has been obtainedNational Medical Products AdministrationApproved.
Screenshot source:CDE Official Website
This is the second indication approved in China for the CAR-T cell injection targeting CD19 and CD22 independently developed by Shanghai Pharmaceuticals Biologics. On October 31, 2023, the first indication of this injection for the treatment of relapsed or refractory acute B lymphoblastic leukemia was approved for clinical trials and is currently in Phase I clinical stage.
（Source: Frontiers in Cell Therapy)
5、Huadong Medicine | Supplemental Application for New Indication of China's First Ustekinumab Injection Accepted by NMPA
220241On February 2, Huadong Medicine Co., Ltd. (hereinafter referred to as "the Company")'s wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as "Zhongmei Huadong"), received the "Acceptance Notice" (Acceptance No.: CYSB2400311) issued by the National Medical Products Administration (NMPA). The supplemental application for Ustekinumab Injection (R&D code: HDM3001/QX001S) for the treatment of pediatric plaque psoriasis submitted by Zhongmei Huadong has been accepted.
(Source: Huadong Medicine Official WeChat)）
Editor: Sesame Walnut
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