Zhangjiang Pharma Valley Monthly Report: Nearly 10 Companies Secured Funding, 5 New Domestic Devices Approved, and Multiple Platforms Launched in February
Henlius
Innovative Biopharmaceutical Company
Johnson & Johnson
Medical Device R&D and Manufacturer
Wave after wave of dreamers with aspirations for new drugs, armed with ideas and experience, have stepped out from research institutes and large multinational platforms to start from scratch in Zhangjiang Pharm Valley. Relying on "innovation," they have turned the once "cold bench" of China's innovative drug market into a hotbed. Zhangjiang Pharm Valley has made the dream of China's innovative drugs a reality.
As a companion on the dream-chasing journey of pharmaceutical entrepreneurs, Yaogu Jun launches a new feature every month."Industry Monthly Report"Fixed Column: Together with everyone, we look back at the hot trends in the life sciences industry and Zhangjiang Medipark enterprises over the past month, witnessing every step of their development.
Policy Orientation
● NMPA Comprehensive Department Publicly Solicits Opinions on the "Guiding Principles for Classification of Rehabilitation Digital Therapeutics Software Products (Draft for Comments)"
On February 11, to guide the determination of the regulatory attributes and classification of rehabilitation-related digital therapeutics software products, the National Medical Products Administration (NMPA) drafted the "Guiding Principles for Classification of Rehabilitation-Related Digital Therapeutics Software Products (Draft for Public Comment)" and solicited public opinions.
●The General Office of the National Medical Products Administration Releases the Notice on the Launch of the Medical Device Industry Standard for "Quality Requirements and Evaluation Methods for EEG Datasets Used in Artificial Intelligence Algorithms in Medical Devices Using Brain-Computer Interface Technology"
On February 17, to ensure the safety and effectiveness of medical devices, encourage research and innovation in medical devices, promote the dissemination and application of new medical device technologies, and advance the development of Shanghai's medical device industry, the Shanghai Medical Products Administration revised the "Special Review Procedures for Class II Innovative Medical Devices in Shanghai" and solicited public opinions.
●Shanghai Medical Products Administration Releases Draft for Public Comment: Special Review Procedures for Innovative Class II Medical Devices in Shanghai (Revised Draft for Comment)
On February 17, in order to ensure the safety and effectiveness of medical devices, encourage research and innovation in medical devices, promote the dissemination and application of new medical device technologies, and drive the development of Shanghai's medical device industry, the Shanghai Medical Products Administration revised the "Special Review Procedures for Class II Innovative Medical Devices in Shanghai" and solicited public opinions.
Major Progress
February 5,Shanghai Henlius Biotech, Inc.Announced that the PD-1 monoclonal antibody HANSIZHUANG® (Serioli, European trade name Hetronifly®) has been approved for marketing by the EU (EC) for first-line treatment of extensive-stage small cell lung cancer.
February 11, 25,Johnson & JohnsonConsecutivelyAnnouncement: The first bispecific antibody drug targeting GPRC5D, Toripalimab Injection (trade name: Talquetamab), has been approved for marketing by the NMPA. It is indicated as a monotherapy for adult patients with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy.Guselkumab Injection (Intravenous Infusion) (Brand Name:Tremfya® and Guselkumab Injection (Trade Name:Tremfya®) has been approved by the NMPA for marketing in China, indicated for adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or biologics.
February 13,Merck & Co.Announced that its new enzyme inhibitor combination product - Cefarozole Sodium and Tazobactam Sodium for Injection (registered trademark: Zhuolidar®) has been approved by the NMPA. It is indicated for use in combination with metronidazole for the treatment of complicated intra-abdominal infections caused by susceptible Gram-negative and Gram-positive microorganisms in adult and pediatric patients; for the treatment of complicated urinary tract infections (including pyelonephritis) caused by susceptible Gram-negative microorganisms in adult and pediatric patients; and for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible Gram-negative microorganisms in adult patients. February 25,Fosun PharmaFirst-in-Class New Drug Tenapanor Hydrochloride Tablets Approved by NMPA for Marketing in China, for Controlling Hyperphosphatemia in Adult Patients with Chronic Kidney Disease Undergoing Hemodialysis.
February 26,Xuanyu MedicalSHINERHYTHM™ Cardiac Pulse Field Ablation System and RHYTHPULSE™ Single-Use Cardiac Pulse Field Ablation Catheter, independently developed, have obtained the Class III Medical Device Registration Certificate issued by NMPA.
Innovate® Cardiac Rhythm MedicalThe all-new TEN series of MRI-conditional safe implantable cardiac pacemakers has been approved by the NMPA for marketing. This is the first and currently the only series of domestically produced cardiac pacemakers in China that are fully compatible with 3.0T whole-body MRI.
MicroPort® RobotThe domestically developed Tumai® Single-Port Endoscopic Surgical Robot has been approved for marketing by NMPA.
CereVasc MedicalRuyi Flow Diverter Stent Approved for Marketing by NMPA.
Antong MedicalThe Iberis® Multi-Polar Renal Artery RF Ablation Catheter System, independently developed, has been approved by NMPA for marketing. It is used for interventional treatment of patients with refractory hypertension and drug-intolerant hypertension.
Zuoxin MedicalThe AnchorMan® Left Atrial Appendage Occluder System, developed in China, has successfully obtained the EU CE MDR certification, becoming the first domestically produced left atrial appendage occluder system in China to receive this certification. Its complementary AnchorMan® Left Atrial Appendage Guidance System was also approved for marketing by the EC during the same period.
Shanghai Henlius Biotech, Inc.Hanbeita® (Bevacizumab Injection, overseas trade name: LONGIVA), independently developed and produced, has been approved for marketing by Bolivia's National Institute of Pharmaceutical and Health Technology.
Project Progress
On February 18, Shanghai Jianshibai Biotechnology Co., Ltd. was officially launched in Zhangjiang.Ginspire Innovation Service PlatformFor various innovative molecules, Ginspire can provide comprehensive early-stage research services, including innovative molecular design optimization, protein structure prediction and modification, linker-toxin screening and conjugation preparation, drug-likeness evaluation, and pharmacological efficacy analysis.
February 26,Zhangjiang Science City Chamber of Commerce Biomedical Professional CommitteeThe first meeting was successfully held. The establishment of the Biomedical Special Committee aims to integrate the biomedical industry resources in Zhangjiang, strengthen industry-university-research cooperation, promote innovative R&D and industrial upgrading in the biomedical field, and provide strong support for Zhangjiang Science City to build a globally competitive biomedical industry cluster.
February 27,Shanghai Biomedical Frontier Industry Innovation Center, Frontiers New Drug Technology Concept Verification Center, "Industry-Education Integration Center of the National Key Laboratory of Innovative Immunotherapy in China", "Shanghai Key Laboratory of Innovative Target Antibody-Drug Conjugates", "External Cooperation Department of Shanghai Pharmaceutical Central Research Institute"At the same time, it was unveiled in Zhangjiang.
The First Radiotherapy Center in Children's Medical Institutions in China——Radiation Therapy Center, Zhangjiang Campus, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, National Center for Children's HealthOfficially launched.
Honors
On February 26, the finals of the "Innovate·In China" International Innovation and Entrepreneurship Competition were held.Silicon羿 TechnologyWon the First Prize in the Small and Micro Group,Circular Biotech, Fangyu HealthAmong the top 20 winning companies.
On February 27, the official ceremony for the second batch of Shanghai Innovative Enterprise Headquarters was held, featuring companies from Zhangjiang.Junshi Biosciences, Hutchison MediPharm, 3SBio, Hua Medicine, Shengdi Pharmaceutical, OptheaBiopharmaceutical enterprises such as Shanghai Henlius Biotech, Inc., and Johnson & Johnson Medical (China) Ltd. have been awarded plaques.
February 27,KomyMed Innovation LabAnnounced the receipt of authoritative certification from the College of American Pathologists and obtained the "Golden Seal," symbolizing honor in the field of laboratory medicine.
Shanghai Municipal Commission of Economy and Informatization Releases the 2024 List of Shanghai's Manufacturing Single Champion Enterprises.3SBioRanked on the list with the product Yisaipu®, a recombinant human Type II Tumor Necrosis Factor Receptor-Antibody Fusion Protein for injection.
"Digital Health Innovation Index in the Biopharmaceutical Industry (2024)" Announced,MerckRated as a leading enterprise in digital health innovation in the biopharmaceutical industry.
The National Center for ADR Monitoring of Medicines issued the "Notice on Commending the 2024 National Units for ADR Monitoring and Evaluation in China,"Hua MedicineListed in the "2024 Annual Commended Pharmaceutical, Medical Device, and Cosmetics Companies".
Capital Dynamics
February 4, 10, and 27,XtalPiAnnounced in succession: signing a strategic cooperation agreement worth tens of millions of RMB with JW Pharmaceutical, and completing strategic investments in Contingent Bio and Fucheng Bio.
February 5,Hantong MedicalAnnounced the completion of a Pre-A round financing worth hundreds of millions, jointly invested by Fortune Venture Capital, Lyfe Capital, and Pudong Angel Venture Capital Fund, among others.
February 20,AstraZenecaReached an agreement with FibroGen to acquire FibroGen China for approximately $160 million.
GemPharmatechCompleted a B+ round of financing worth tens of millions of yuan, with participation from investment by Cold Creek Capital.
Ensheng MedicalCompleted a new round of financing worth tens of millions of yuan, with a special venture capital fund established by Anhui Xinhua Group Investment Co., Ltd. in collaboration with professional investors participating in the investment.
MicroZhuo BiotechCompleted a RMB 200 million Series B+ financing round, led by Shanghai BioPharmaceutical Fund under Shanghai Industrial Capital, with continued support from existing shareholder Longpan Investment, and joint participation by Guanghua Wutong.
MethuselahCompleted nearly 200 million yuan in Series B financing, jointly led by funds under CICC Capital, Hongsheng Capital, and Highlighter Fund, with participation from Brizan Capital and Frees Fund.
Sedec DevelopmentCompleted over 100 million yuan in Series B financing, jointly led by H&L Biotech Fund and Shanghai BioPharmaceutical Fund under Shanghai Industrial Capital.
Kelan PharmaceuticalsCompleted over RMB 100 million in Series A+ financing, led by SDIC Venture Capital Fund.
Tuanxiang PharmaceuticalsCompleted a Pre-A round of financing worth tens of millions of yuan, led by the Pudong Venture Capital Group's Pudong Technology Investment Angel Fund, with continued additional investment from existing shareholder StarVest Partners.
Pharmaceutical Transactions
February 6,Shanghai Henlius Biotech, Inc.Announced collaboration with Dr. Reddy's Laboratories SA on its independently developed investigational daratumumab biosimilar – recombinant anti-CD38 fully human monoclonal antibody injection.HLX15Sign the Authorization and License Agreement.
February 25,CARsgen TherapeuticsAnnounced an agreement with a fund managed by Zhuhai SoftBank Xinchuang to jointly invest in Youkaize. According to the terms of the agreement, Youkaize has obtained exclusive rights for the research, development, production, and commercialization in mainland China of CARsgen Therapeutics' off-the-shelf BCMA CAR-T cell product for the treatment of multiple myeloma and plasma cell leukemia, as well as the off-the-shelf CD19/CD20 CAR-T cell product for the treatment of B-cell malignancies.
ByHarbour BioMedHBM Alpha Therapeutics Inc. (referred to as “HBMAT”), an innovative biotechnology company, announced a strategic collaboration and licensing agreement with a business partner to jointly advance novel corticotropin-releasing hormone (CRH) targeted therapies for multiple diseases. Under the agreement, the partner obtains exclusive rights to develop and commercialize HAT001, a potent and selective CRH-neutralizing antibody, in global markets outside of China (including Hong Kong, Macao, and Taiwan).
(Edited by the Pharmagu Team)
