Weekly Life Sciences Update (No.7): Key Approvals, Clinical Advances, and Strategic Collaborations in China's Biopharma Sector (Feb 22–28, 2025)
Johnson & Johnson
Medical Device R&D and Manufacturer
Fosun Pharmaceutical
Healthcare Industry Group
ShineyoMedical
Provider of Atrial Fibrillation Electrophysiology and Peripheral Vascular Intervention Solutions
Hansoh Pharma
Pharmaceutical Research, Production, and Sales
Weekly Dynamics in Life Sciences (No.7)
2025.2.22-2025.2.28
Innovation never stops, and progress keeps moving forward. What are the latest developments in Zhangjiang's life science industry over the past period? Take a quick look↓
February 25,Johnson & JohnsonIt was announced that Guselkumab Injection (Intravenous Infusion) (brand name: TREMFYA Reach®) and Guselkumab Injection (brand name: TREMFYA®) have been approved by the NMPA for marketing in China. They are indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response, or were intolerant to conventional therapy or biologics.
February 25,Fosun PharmaceuticalFirst-in-Class New Drug Tenapanor Hydrochloride Tablets Approved by NMPA for Marketing to Control Hyperphosphatemia in Adult Patients with Chronic Kidney Disease Undergoing Hemodialysis
February 26,ShineyoMedicalSHINERHYTHM™ Cardiac Pulse Field Ablation Instrument and RHYTHPULSE™ Single-Use Cardiac Pulse Field Ablation Catheter, independently developed by ShineyoMedical, have obtained the Class III medical device registration certificate issued by NMPA.
Recently,Zuoxin MedicalThe AnchorMan® Left Atrial Appendage Occluder System, developed by ShineyoMedical, has successfully obtained the EU CE MDR certification, becoming the first domestically produced left atrial appendage occluder system in China to receive this certification. The accompanying AnchorMan® Left Atrial Appendage Guidance System was also approved for marketing in the EU during the same period.
Recently,Antong MedicalThe self-developed Iberis® Multi-Pole Renal Artery RF Ablation Catheter System Receives NMPA Approval for Market Launch, Used for Interventional Treatment of Resistant Hypertension and Drug-Intolerant Hypertension Patients.
Recently,PfizerHemophilia Innovation Therapy HYMPAVZI™ (Marstacimab) Officially Launched in Boao Lecheng Pilot Zone, Hainan.
Project Progress
February 24,Boehringer IngelheimAnnounced that the NDA for its investigational oral phosphodiesterase 4B inhibitor, nerandomilast, for the treatment of adult idiopathic pulmonary fibrosis, has been accepted by the CDE.
February 25,Linnuo PharmaceuticalThe IND application for the Class 1 new drug SLN12140 for injection has been approved by the CDE, and it is proposed to be developed for the treatment of primary IgA nephropathy.
February 25,Hansoh PharmaConsecutivelyAnnouncement: The IND application for the Class 1 small molecule Bruton's tyrosine kinase inhibitor HS-10561 capsule, developed in collaboration with Lupon Pharma, has been approved by the NMPA. Clinical trials are planned to treat chronic spontaneous urticaria.HS-20093 for Injection, a Self-developed B7-H3 Targeting ADC Drug, Approved by NMPA for Inclusion in Breakthrough Therapy Designation, with a Proposed Indication for the Treatment of Osteosarcoma Patients Who Have Progressed After at Least Two Prior Lines of Therapy.
February 25,Compass BiopharmaceuticalsAnnounced that the IND application for its self-designed and developed next-generation oral molecular glue immunomodulatory drug KPG-818 capsule, which has global independent intellectual property rights, has been approved by the CDE to conduct clinical trials for the treatment of relapsed or refractory multiple myeloma.
February 26,Insilico MedicineIt was announced that, with the support of its generative chemistry platform Chemistry42, the Therasid R&D team successfully discovered a candidate compound with required physicochemical properties after synthesizing and testing approximately 40 molecules in just four months. Moving forward, these molecules will be further developed under Therasid’s leadership, including advancing preclinical validations such as in vitro and in vivo experiments.
February 26,Everest MedicinesFull Maintenance Phase Data from the Asian Multicenter Phase III Clinical Trial of Itrumod for Moderate to Severe Active Ulcerative Colitis Presented as an Oral Report at the 20th European Crohn's and Colitis Organisation Congress: The proportion of patients in the Itrumod group achieving clinical remission at week 40 was significantly higher than in the placebo group, with a clinically significant difference. All key secondary endpoints and clinical response outcomes also demonstrated significant clinical and statistical improvements.
Recently,Yinuo PharmaceuticalThe global launch ceremony of the self-developed Ersupaglutide α Injection (brand name: Yinoqing®) was officially held, and it was first launched online, rapidly improving the drug's accessibility.
Recently, a bag of lymphoma patient's blood single harvest product was sent out from Hong Kong International Airport, arrived at Shanghai Pudong International Airport on the same day, and was delivered to the destination in the first time.Fosun KarryCell Factory: From Plane Landing to Completion of Declaration, Inspection, and Release Took Only 4 Hours. Thus, the Joint Supervision Mechanism for Special Items in Biomedicine, a Domestic First Established by More Than Ten Departments in Shanghai, Has Opened Up the "Going Overseas" Path for Cell Therapy Products.
Recently, the Urology Department of Oriental Hospital successfully conducted a caseMicroPort® RobotToumai® Robot-Assisted Laparoscopic Adrenalectomy for Pheochromocytoma Achieves Full Coverage of Robot-Assisted Laparoscopic Landmark Procedures in the Urology Department of Oriental Hospital.
Recently,CanSino BiologicsIND Application for Combined Vaccine of Adsorbed Acellular Pertussis (Component) Tetanus Toxoid, Haemophilus Influenzae Type b (Conjugate), and Meningococcal ACYW135 (Conjugate) Approved by NMPA.
Recently,Akeso BiopharmaAnnounced that the first patient has been enrolled in the Phase III clinical trial of its independently developed PD-1/VEGF bispecific antibody, Ewoxi, in combination with a regimen for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer.
Recently, the 26th European Society of Gynaecological Oncology (ESGO) Congress officially opened.Hengrui MedicineResults of the Phase II Clinical Trial of SHR-2004, a Self-Developed Factor XI Inhibitor, for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Ovarian Cancer Surgery Presented in Oral Report. The results showed that postoperative subcutaneous injection of SHR-2004 in ovarian cancer patients demonstrated encouraging efficacy in preventing VTE with a good safety profile.
Recently,Langxin BioLinnuo (Shanghai) Pharmaceutical Technology Co., Ltd. announced the latest clinical trial results of its self-developed LX102 gene therapy for neovascular age-related macular degeneration at the 2025 Annual Meeting of Macula Society and Angiogenesis, Exudation, and Degeneration: All patients in the Phase I clinical trial have completed at least one year of observation, with all nine subjects receiving medium to high doses not requiring supplemental anti-VEGF drug treatment; the first subject in the investigator-initiated trial (IIT) completed a 30-month follow-up, with vision showing sustained and stable improvement.
Recently, Dr. Jin Qi, Chief Physician of the Cardiology Department at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, successfully completed the first batch of Magbot™ robot-assisted navigation surgeries. The surgery utilizedMinimally Invasive ElectrophysiologyMagbot™ Single-Use Magnetic Navigation Saline Irrigation Radiofrequency Ablation Catheter and Columbus® 3D Cardiac Electrophysiology Mapping System, in conjunction with the Genesis RMN™ Cardiac Electrophysiology Robotic Magnetic Navigation System, were used to perform precise and efficient radiofrequency ablation treatment on three patients with arrhythmia.
Recently,ShineMed™The Castor® Branched Aortic Stent Graft and Delivery System successfully completed its first clinical implantation in Macao, China, marking the official entry of Heartpulse Medical™ products into the Macao market for the first time.
Recently,Gifore PharmaceuticalsAnnounced that its self-developed oral small molecule KRAS G12D (ON/OFF) inhibitor GFH375 monotherapy has entered Phase II clinical research. The study will evaluate the efficacy, safety, and pharmacokinetic characteristics of GFH375 in patients with various advanced solid tumors harboring the KRAS G12D mutation. Currently, the first patient has been enrolled and completed the first dosing.
Capital Dynamics
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, 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 its off-the-shelf CD19/CD20 CAR-T cell product for the treatment of B-cell malignancies. February 27,XtalPiAnnounced the completion of strategic investment in Fuhe Biotech. Recently,Kelan PharmaceuticalCompleted over RMB 100 million in Series A+ financing, led by SDIC Venture Capital Fund. Recently,ShineyoMedicalAnnounced the completion of a multi-million yuan Pre-A round of financing, led by the Pudong Venture Capital Group's Pudong Technology Investment Angel Fund, with continued additional investment from existing shareholder Neighboring Star Ventures.
Recently, byHarbour BioMedHBM Alpha Therapeutics Inc. ("HBMAT"), an incubated 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 has obtained exclusive rights to develop and commercialize HAT001, a potent and selective neutralizing antibody targeting CRH, in global markets outside of China (including Hong Kong, Macao, and Taiwan).。
External Cooperation
February 24,Shanghai Linzhuan HospitalSign Strategic Cooperation Agreements with Ping An Health Insurance and Peking University Medical Group. The three parties will collaborate in areas such as data-driven commercial insurance product development and medical AI applications, jointly exploring new pathways for innovation and development in the healthcare industry.
February 25,MediChorusOncotelic Therapeutics and its 45%-owned Sapu Bioscience announced a strategic partnership. Mediso will leverage its one-stop preclinical comprehensive R&D service platform for biopharmaceuticals to provide integrated preclinical R&D support, including drug discovery, pharmaceutical research, and preclinical studies. Over the next five years, this collaboration aims to accelerate the Investigational New Drug (IND) applications of 20 novel drug projects, covering innovative drugs such as nucleic acid therapeutics and nanomedicine formulations.
February 27,EpimAb BiotherapeuticsMedigene Announces Strategic Collaboration Agreement to Research and Develop TCR-Mediated T Cell Engager Therapies for the Treatment of Immune-Related Diseases Such as Solid Tumors.
Recently,Akeso BiopharmaEvoair is developed by Summit Therapeutics andPfizerReach a clinical trial collaboration to jointly advance the application of Akeso Biopharma's self-developed PD-1/VEGF bispecific antibody, Eveci, in combination with Pfizer’s multiple antibody-drug conjugates for the treatment of various solid tumors.
Major Release
On February 22, the First Membership Meeting and Biomedical Development Conference of the Shanghai Federation of Industry and Commerce Biomedical Chamber was officially held.Fosun PharmaceuticalNon-executive Director Chen Qiyu elected as the first president.
On February 26, the final of "Innovation·In China" International Innovation and Entrepreneurship Competition was successfully held.ShineyoMedicalWon the First Prize in the Small and Micro Group,CircleBio, Fangyu HealthAmong the top 20 winning companies.
February 26,Shanghai Institute of Materia MedicaIn collaboration with the research group led by Xie Qing from the Department of Infectious Diseases at Ruijin Hospital, affiliated with Shanghai Jiao Tong UniversityCell MetabolismPublished a research paper.The study revealed that SMPD3-mediated hepatocyte membrane sphingomyelin metabolic reprogramming is a key factor driving ceramide accumulation in the MASH phase, and found:SMPD3 is a key node linking various core pathological processes of MASH, such as lipid metabolic disorders, cell injury, inflammation, and fibrosis.
February 26,Zhangjiang Science City Chamber of Commerce Biomedical Professional CommitteeThe First Meeting Successfully Held. The establishment of the Biomedical Special Committee aims to integrate the biomedical industry resources in Zhangjiang, strengthen industry-university-research cooperation, promote innovation and R&D in the biomedical field as well as industrial upgrading, providing strong support for Zhangjiang Science City to build a globally competitive biomedical industry cluster.
February 27,Shanghai Biomedical Frontier Industry Innovation Center - Advanced New Drug Technology Concept Validation Center、“National Key Laboratory of Innovative Immunotherapy Industry-Education Integration Center", "Shanghai Key Laboratory of Innovative Target Antibody-Drug Conjugates", "External Cooperation Department of Shanghai Pharmaceutical Central Research Institute"Unveiled simultaneously.
On February 27, the second batch of Shanghai Innovative Enterprise Headquarters award ceremony was officially held. The 49 innovative enterprise headquarters awarded this time cover key industry areas such as integrated circuits, biomedicine, artificial intelligence, digital economy, and strategic emerging industries. Among them, from Zhangjiang...Junshi Biosciences, Hutchmed, 3SBio, Hua Medicine, Shengdi Pharmaceutical, OptheaBiopharmaceutical enterprises such as Fosun Pharmaceutical, Hansoh Pharma, Linnuo (Shanghai) Pharmaceutical Technology Co., Ltd., Johnson & Johnson, and ShineyoMedical were awarded.
February 27,Kemilo 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.
Recently,Shanghai Advanced Research InstituteTang Zhiyong's team and Ning Dejun's team proposed an axial pressure prediction model for industrial gas-solid fluidized beds based on Scale-Invariant Feature Transform (SIFT) and Adaptive Optimization Random Forest algorithm, building on their series of research into AI-assisted gas-solid fluidization equipment digital intelligence. The relevant work has been published inPowder TechnologyUp.
Recently,National Children's Medical Center, Zhangjiang Campus of Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of MedicineThe radiation therapy center has been officially launched. This is the first radiation therapy center in China's pediatric medical institutions.
Recently,School of Pharmacy, Fudan UniversityJiang Chen and Sun Tao's team successfully developed a drug delivery system with transcytosis and hypoxia-responsive functions, mediated by enamine N-oxide. The relevant research findings were published inNano Letters。
Recently,Shanghai University of Traditional Chinese MedicineChief Professor XU Hongxi's TeamMolecular CancerPublished a review paper. The paper systematically reviews the historical evolution and theoretical basis of traditional Chinese medicine (TCM) in treating lung cancer, comprehensively summarizes recent clinical application achievements of TCM in lung cancer treatment, and provides an in-depth analysis of the multiple mechanisms of action of TCM against lung cancer.
Recently,Insilico MedicineWith the help of an AI-driven robotic laboratory, it was discovered that its self-developed small molecule TNIK inhibitor, Rentosertib, is a potentially highly effective anti-aging factor that can significantly alleviate cellular senescence. The relevant research findings were published inAging and DiseaseUp.
Recently,HenliusTrastuzumab (Trade name: HanscuHope®) International Multicenter Phase III Clinical Trial 3-Year Follow-Up Update Results Published inThe BreastThe follow-up analysis results indicate that Hanquyou® and the original trastuzumab have similar long-term efficacy, safety, and immunogenicity in HER2-positive metastatic breast cancer patients who have not received systemic treatment, further validating their clinical equivalence.
Recently,Hansoh PharmaResearch on the long-acting mechanism of Pegmocept (trade name: Sinrolin®) published inJournal of Translational MedicineThis in vitro study, for the first time, validated that pemolanib binds more stably and durably to EPOR in vitro. By maintaining the expression of EPOR on the cell surface, it sustains the continuous activation of downstream signaling pathways to promote erythropoiesis, thereby providing a strong theoretical basis for the long-acting erythropoiesis-stimulating effect of pemolanib.
Recently,AutobioThe combined detection kit for Human Immunodeficiency Virus (HIV) antibody and antigen (magnetic microparticle chemiluminescence method), along with the Hepatitis C Virus (HCV) IgG antibody detection kit (magnetic microparticle chemiluminescence method), has successfully passed European clinical evaluation and received the highest risk level CE IVDR Class D certificate issued by TÜV SÜD, an EU Notified Body.
Recently, the Shanghai Science and Technology Commission announced the approval of the first batch of Shanghai High-tech Achievements Transformation Projects for 2025.3SBioRecombinant Human Type II Tumor Necrosis Factor Receptor-Antibody Fusion Protein Injection (Yisaipre-filled Syringe) has been included in the list.
Recently, the National Center for ADR Monitoring of Medicines issued the "Notice on Commending the National Units for ADR Monitoring and Evaluation in 2024".Hua Ling PharmaceuticalListed in the "2024 Annual Commended Pharmaceutical, Device, and Cosmetic Enterprises" list, recognized for outstanding performance in fulfilling primary responsibilities, and as the only pharmaceutical company in Shanghai to receive commendation.
(Edited by the Pharmagu Team)
