Weekly Update on Life and Health (No.51): December 23–29, 2024
BeOne
Developer of Molecular Targeted and Immune Anti-Tumor Drugs
Henlius
Innovative Biopharmaceutical Company
Novabio Therapeutics
Developer of Multi-Modal Treg Cell Therapy
Immunofoco
Developer of Novel Therapeutics for Solid Tumors
NK CellTech
Immune Cell Therapy Developer
Hengrui Pharma
Innovative and High-Quality Pharmaceutical Developer
Weekly Dynamics in Life and Health (No.51)
2024.12.23-12.29
Innovation never stops, and progress continues. What are the latest developments in Zhangjiang's biopharmaceutical industry over the past week? A quick overview ↓
December 23,MICURXMICURX's self-developed anti-infective new drug MRX-5 has been granted Orphan Drug Designation by the FDA for the treatment of non-tuberculous mycobacterial infections.
December 23,Roche PharmaAnnounced that Haorohua® (Mototuzumab) has been approved by the NMPA for marketing, as a single agent for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received at least two lines of systemic therapy.
December 23,AbbVieAnnounced that Upadacitinib Sustained-Release Tablets have been included in the CDE's priority review for the second time.First review, intended for the treatment of adult giant cell arteritis.
December 25,Boehringer IngelheimThe oral HER2 inhibitor zongletinib (BI 1810631) has been proposed by the CDE for priority review, intended for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer carrying HER2 (ERBB2) activating mutations and who have previously received systemic therapy.
December 27,BeOne MedicinesBeOne Medicines announces that Tislelizumab (Brand name: Baizean®) has been approved by the FDA for first-line treatment in adult patients with unresectable or metastatic HER2-negative gastric or gastroesophageal junction cancer whose tumors express PD-L1 (≥1), in combination with platinum and fluorouracil-based chemotherapy.
Recently,ListentThe self-developed auricular vagus nerve stimulator has obtained the medical device registration certificate issued by NMPA.
Recently,Heartflow MedicalVitaFlow Liberty® Transcatheter Aortic Valve and Retrievable Delivery System, a Second-Generation Transcatheter Aortic Valve Implantation Product Independently Developed, Approved for Marketing in India.
Project Progress
December 24th,Shanghai Henlius Biotech, Inc.Shanghai Henlius Biotech, Inc. announced that the international multi-center Phase III clinical trial of HLX78 (Lasofoxifene Tablets) in combination with Abemaciclib for the treatment of patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer, who have previously received aromatase inhibitor therapy and have mutations in the estrogen receptor alpha gene, has completed the first patient dosing in China.
December 24,NOVABIOTXThe self-developed NP001 product has completed the first dosing in a patient with amyotrophic lateral sclerosis (ALS).
December 25,Fangto BiotechAnnounced that the second indication of its self-developed innovative AAV gene therapy product FT-003 injection has received FDA approval for Phase II IND application, intended for the treatment of diabetic macular edema.
December 25,ImmunofocoAnnounced that the IND application for a new indication of its self-developed EpCAM-targeted autologous CAR-T cell injection product IMC001 has been accepted by the CDE for the treatment of advanced epithelial solid tumors.
December 26,Enkaithera PharmaPhase I Clinical Trial of NK042 Cell Injection Officially Launched.
December 26th and 27th,Hengrui PharmaIt was successively announced that the IND applications for the innovative drugs HRS-4357 and SHR-4602 for injection were approved by the NMPA, respectively for the treatment of prostate cancer in combination with ADT and novel androgen receptor pathway inhibitors, in combination with Recombinant Trastuzumab for Injection, or in combination with Recombinant Trastuzumab for Injection and Adebrelimab, or in combination with Recombinant Trastuzumab for Injection, Adebrelimab, and SHR-8068 for the treatment of advanced solid tumors.
Recently,Zelgen PharmaIND Applications for ZG005 Injection and Gikacetinib Hydrochloride Tablets in Combination for Advanced Solid Tumors and Relapsed/Refractory Lymphoma Approved by NMPA.
Recently,Yingli PharmaAnnounced that the IND application for the novel pan-PARP inhibitor AK-1286 has been approved by the NMPA.
RecentlyDay,BayerAnnounced that Aflibercept 8mg has reached the primary endpoint in global Phase III clinical trials.
December 25,Huao Tai BioAnnounced the completion of 200 million yuan in financing, exclusively invested by Haizheng Ventures.
Listed Trading
December 23,BeOne MedicinesIt was announced that the NASDAQ stock code will be changed to "ONC" on January 2, 2025.
December 27,Geffen PharmaHKEX IPO Application Accepted.
Authorized Transaction
December 23,Jiyu PharmaRAPT Therapeutics announced an exclusive licensing agreement for JYB1904 (RPT904), a clinically-stage, half-life extended anti-immunoglobulin E monoclonal antibody developed by Jiyu Pharma.
December 29,Hengrui PharmaHengrui Pharma announced that it has granted IDEAYA Biosciences the exclusive rights, for a fee, to develop, manufacture, and commercialize its self-developed Delta-like ligand 3 (DLL3) ADC innovative drug SHR-4849 outside of China (including Hong Kong, Macao, and Taiwan).
Recently,ShanghaiTech UniversitySign patent license agreements with Shanghai Zhuanma Biotechnology Co., Ltd. and Shanghai Miaozhi Technology Co., Ltd. respectively.
Major Release
December 23,Shanghai Institute of Materia MedicaLi Yaping's team and Zhang Jiwen's team respectivelyAdvanced Materials、Carbohydrate PolymersPublication of research results on personalized nanovaccines activating B cell-mediated anti-tumor immune responses and nano-mesh structured carriers encapsulating engineered extracellular vesicles for pulmonary drug delivery.
December 24,Hengbo PharmaDrug Insight Platform V1.0 Receives Software Copyright Registration Certificate from the National Copyright Administration of China.
December 26,JW TherapeuticsAwarded the "2024 ESG Pioneer Award" in the corporate social responsibility case selection hosted by CNR Network.
December 27,Ark BiopharmaPartex announces strategic cooperation to fully explore the potential of AK0707, an autocrine motility factor inhibitor independently developed by Ark Bio.
December 27,Dizhe PharmaAwarded the 2024 "Golden Quality" Scientific Innovation Award by the Shanghai Securities News.
Recently,BrainLinkNEO Minimally Invasive Brain-Computer Interface System SelectedNature"Scientific Events to Watch in 2025"
Recently,Final of the 9th "Zhangjiang Cup" Science and Technology Innovation Talent Competition and the 2nd Yangtze River Delta Science and Technology Innovation Talent Competition in 2024InZhangjiang AI IslandHold,LianRen Health"YOUSHARE AI-Driven Intelligent Medical Record Summarization" Project Wins First Prize in the Artificial Intelligence - System Platform Category,XinKaiNuo Medical"SkyFlow Intracranial Thrombectomy Stent" Project Wins First Prize in the Biomedical Category,OPMDr. Ding Yue's team, CDMO Antibody Engineering Deputy Director, won the third prize in the biopharmaceuticals category for the project "Transient Chassis 293 Cell Modification."
Recently,Heartlight BiotechShortlisted for the 2024 Shanghai Innovative Small and Medium-sized Enterprises (Third Batch) List.
Recently,FastSeq Bio"Next-Generation Protein Sequencing Technology R&D Project" Selected for the "2024 Shanghai Annual 'Science and Technology Innovation Action Plan' Technological Innovation Fund for SMEs" Project List.
Recently,Blood霁 BioThe "Leukemia Accessible Cell Therapy Technology" undertaken has been selected into the list of key special projects for disruptive technological innovation under the National Key R&D Program.
Recently,Heartpulse Medical™Castor® Branched Aortic Stent Graft and Delivery System Wins China Patent Gold Award.
Recently,HutchmedFeatured in the 2024 "ESG Leading Companies" list by Bloomberg Businessweek, and received the "ESG Leading Community Project" and "Special Category - Sustainable Supply Chain" awards.
Recently,Dagene BioAttended the Johnson & Johnson Innovation JLABS Global CEO Summit and won the JLABS Annual Innovation Best Deal Award.
Recently,Zhangjiang Traditional Chinese Medicine Cultural Festival and Zhangjiang Science City New Quality Productivity Empowering Pharmaceutical Industry Exchange EventThe "Traditional Chinese Medicine Herb Popular Science Alliance" was officially established.
(Edited by the Yaogu Jun team)
