Zhangjiang Pharma Valley Weekly Update (No.21): Multiple Breakthroughs in R&D, Regulatory Approvals, and Financing

June 3,Shanghai Institute of Materia Medica, Chinese Academy of SciencesIn collaboration with the team of Qiu-Rong Ding from the Shanghai Institute of Nutrition and Health, Chinese Academy of Sciences; the team of Li-Ming Tang from the Third Affiliated Hospital of Nanjing Medical University (Changzhou No. 2 People's Hospital); and the team of Chun-Ping Jiang from the Drum Tower Hospital Affiliated to Nanjing University Medical School, the Xie Cen team systematically elucidated a novel mechanism by which uric acid links hyperuricemia, dietary lipid absorption, and the development of obesity. This work was published in“Uric acid promotes dietary lipid absorption through microbiome and metabolomic remodeling via a liver-gut endocrine axis”titled “,” published inCell Host & Microbeon.

Recently,Shanghai East Hospital (Tongji University Affiliated East Hospital)Professor Tang Juan from the Institute of Regenerative Medicine, Stem Cell Base / School of Life Sciences and Technology, Tongji University, andShanghaiTech UniversityProfessor Zhang Hui’s team from the School of Life Sciences and Technology, in collaboration withCirculationThe journal published a breakthrough study that systematically revealed, for the first time, the critical role of P16-positive cells in adverse cardiac remodeling and proposed novel precision intervention strategies targeting CCL8 signaling or P16-positive fibroblasts.

Recently,XtalPiIn collaboration with Sun Yat-sen University, an innovative solution was proposed: the development of visible light-mediated EDA complexes to gently activate S(VI)–F bonds using a “photonic key.” The Future Chemistry Department of XtalPi, in partnership with the research groups of Professor Lu Gui and Associate Professor Weng Jiang from the School of Pharmaceutical Sciences at Sun Yat-sen University, successfully developed a novel sulfur-fluoride exchange (SuFEx) reaction strategy based on visible-light photoredox catalysis. This research finding was published as“Radical C–SuFEx Ligation via Photoinduced Electron Donor-Acceptor Complex”as the title, published in the internationally renowned chemistry journal Angewandte Chemie (Angewandte Chemie International Edition）。

June 1,ShineyoMedical"Adjustable Curved Pulmonary Artery Embolectomy Stent System" Approved by NMPA for Market Launch.

June 2,UniXelI BIOTECHNOLOGYAnnouncement: The Company’s Self-Developed Epilepsy Cell Therapy Drug, UX-GIP001 Injection, Granted Fast Track Designation by the FDA

June 2,CorrectseqAnnouncement: The first patient in China with sickle cell disease (SCD) to receive base-editing clinical therapy has remained free of vaso-occlusive crises (VOCs) for over 15 months following treatment with CS-206 injection. The patient received the CS-206 infusion on February 14, 2025, with the last transfusion occurring on day 11 post-infusion. Since the infusion, the patient has experienced no further VOCs and has maintained freedom from anemia, thereby achieving the primary efficacy endpoint.

June 2,XtalPiAnnounced that, leveraging its AI-powered peptide development platform PepiX™, the company has successfully independently developed an innovative oral food ingredient focused on blood glucose health management—Tensotide™—which has received U.S. Self-affirmed GRAS (Generally Recognized As Safe) status.

June 4,Hansoh PharmaceuticalAnnouncement: The New Drug Application (NDA) for Olepatide Injection, independently developed by the Company, has been accepted by the NMPA for long-term weight management in adults with obesity or overweight.

June 4,Fosun PharmaAnnouncement: The First Patient Has Been Dosed in the Phase I Clinical Trial in China of FXS0683, an Orally Administered Innovative Small-Molecule Drug Independently Developed by the Company for Hematologic Malignancies.

June 5,GenFang PharmaceuticalsAnnounced that the Company’s independently developed GFH375/VS-7375 (an oral KRAS G12D inhibitor) has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of patients with previously treated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring KRAS G12D mutations (who have previously received platinum-based chemotherapy and PD-1/PD-L1 inhibitors, either concurrently or sequentially).

June 5,Mabwell BioscienceAnnounced that the company’s independently developed innovative antibody drug, 9MW5211, has received approval from the NMPA to conduct clinical trials for inflammatory bowel disease (IBD).

Recently,Lingnuo PharmaceuticalsAnnounced that the Phase II clinical trial of SLN12140, a Class 1 innovative complement inhibitor independently developed by the company for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), has successfully completed enrollment of all patients.

June 2,DingKang BiologicsJointly announced with Daewoong Pharmaceutical, a leading South Korean pharmaceutical company, that both parties have officially signed a strategic cooperation agreement to collaborate on the development and manufacturing of dupilumab biosimilars, with Dupixent as the reference product. Through this collaboration, Biologics International Corp. (BIC) will leverage its extensive one-stop experience in biosimilar development and commercialization, its advanced AI-enabled development platform (Chime AI Platform), and China’s rapidly evolving bioprocessing supply chain ecosystem (Chime Innovation Alliance) to support Daewoong Pharmaceutical in advancing its global biosimilar strategic layout.