Dandelion Bio·News | Top Headlines in Biopharma (Nov 7–13, 2024)

Nov 17, 2024 18:31 CST Updated 18:31

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CDE| "Technical Requirements for Pilot Registration of Segmented Production of Antibody-Drug Conjugates"

2024On November 7, CDE releasedTechnical Requirements for Pilot Registration of Segmented Production of Antibody-Drug ConjugatesThe announcement will take effect from the date of issuance.(View related readings by clicking)

This document applies to marketing applications or post-marketing change supplements for ADC products included in the segmented production pilot program, guiding the research, development, and registration of small molecules, bulk solutions, or formulations produced in segmented stages.

(Source：Center for Drug Evaluation, National Medical Products Administration）

Recipient

Reason

Affection

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CDE Acceptance Status

November 7, 2024From November 1 to November 13, the Center for Drug Evaluation (CDE) of the China National Medical Products AdministrationA total of 361 drugs were acceptedIndividual, among whichBiological Products 46（22 new drugs and 4 imported）。

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(Source: Center for Drug Evaluation, National Medical Products Administration)

Enterprise

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1、CSPC | mRNA Therapeutic Vaccine Approved for Clinical Trial, Targeting Cervical Precancerous Lesions

2024November 12, CDE official website announcement,CSPCCSPC's New Drug SYS6026 Injection Approved for Clinical Trials, Intended for Development in TreatmentHuman Papillomavirus (HPV) Patients with high-grade squamous intraepithelial lesions (HSIL) associated with types 16/18. According to publicly available information,This is aTherapeutic Vaccine, targeting the early protein antigens E6 and E7 of HPV16 and 18 subtypes.This is the first time that the product has been approved for IND in China.

（Source: CSPC Official WeChat)

2、Laien Bio | mRNA-encoded TCR-T Approved for Clinical Trials, Precisely Targeting Hepatocellular Carcinoma

2024Year 11DecemberDayAccording to the CDE official website, Guangzhou Laien Biological Medicine Co., Ltd. (hereinafter referred to as "Laien Bio") has received clinical trial implied permission for its self-developed First-in-Class "GZL-016 Injection," indicated for hepatitis B virus-related hepatocellular carcinoma.This is the world's first mRNA-encoded TCR-T cell therapy targeting the hepatitis B virus (HBV)., which is another significant achievement for Laien Biomedical after obtaining the implied approval from the U.S. FDA and Singapore's HSA. It also marks the official entry of this therapy into the clinical trial stage in China, laying the foundation for its future global market launch.

Screenshot source:CDE Official Website

(Source: CDE official website)）

3、CHIATAI TIANQING | KRAS G12C Targeted Drug Geosorrset Approved for Marketing

22024On November 8, the official website of the National Medical Products Administration (NMPA) announced that CHIATAI TIANQING's jointly developed KRAS G12C inhibitor, Gosorese Tablets (brand name: Anfangning), has been approved for marketing. It is indicated for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring the mouse sarcoma virus oncogene (KRAS) G12C mutation who have received at least one prior systemic therapy.This is CHIATAI TIANQING's fourth Class 1 innovative drug approved this year., which is another breakthrough achieved by the company in the field of lung cancer.

(Source: CHIATAI TIANQING Official WeChat)）

4. Autolus Therapeutics | Next-Generation CAR-T Therapy Receives FDA Approval

November 2024On August 8, Autolus Therapeutics announced that the Biologics License Application (BLA) for its next-generation CAR-T therapy, Aucatzyl (Obecabtagene autoleucel, obe-cel), has been approved by the U.S. FDA for the treatment of relapsed/refractory (r/r) adult B-cell acute lymphoblastic leukemia (ALL) patients. According to publicly available information,Aucatzyl is the first CAR-T therapy approved by the FDA without a REMS program (Risk Evaluation and Mitigation Strategy).。

(Source: Cell and Gene TherapyField）

5、V立志博 |Tri-specific Antibody New Drug Secures Licensing Deal Exceeding $600 Million

2024November 7,V立志博与风险投资公司Aditum Bio宣布，基于V立志博CD19xBCMAxCD3 Trispecific T Cell Engager AntibodyLBL-051 Establishes New Drug R&D Company Oblenio Bio (referred to as "Oblenio") and Reaches Exclusive Option and License Agreement. Aditum will provide funding for Oblenio, and both parties will collaborate to rapidly advance LBL-051 into clinical research.

According to the terms of the agreement, Leadbiologics will grant Oblenio an exclusive option and license for the global development, manufacturing, and commercialization of LBL-051. Leadbiologics is entitled to receive an upfront payment and near-term payments totaling $35 million. Upon achieving development, regulatory registration, and sales milestones, Leadbiologics will also be eligible to receive up to $579 million in total transaction proceeds, as well as royalties on future product sales. Additionally, Leadbiologics will have the right to obtain equity in Oblenio.

（Source: Weili Zhibo Biotechnology Official WeChat)

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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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