Greater China News
Foresee Pharmaceuticals Announces FDA Orange Book Listing of New U.S. Patent for CAMCEVI®, Extending Patent Protection to 2039
Foresee Pharmaceuticals (TPEx: 6576), ("Foresee") today announces that a new U.S. patent which covers CAMCEVI® (leuprolide mesylate) and its labeled indication is now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as "the Orange Book".
Asieris Obtained IND Approval from NMPA for APL-1401, a Drug for the Treatment of Moderately-to-Severely Active Ulcerative Colitis
Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the National Medical Products Administration （NMPA） has approved the Investigational Drug (IND) application for its oral drug APL-1401 for the treatment of moderately-to-severely active ulcerative colitis (UC).
InxMed Receives Approval to Initiate Phase I Clinical Trial in China for OMTX705, a First-in-Class FAP-Targeting ADC
InxMed, a clinical-stage biotechnology company dedicates on developing innovative therapies targeting drug resistance for hard-to-treat solid tumors，announced today the first-in-class ADC OMTX705 has obtained the IND (Investigational New Drug) approval from China National Medical Products Administration (NMPA) recently.
Harbour BioMed Announces US IND Clearance of Its First ADC Program HBM9033 in Solid Tumors
Harbour BioMed (the"Company", HKEX: 02142) announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its first antibody drug conjugate (ADC) program HBM9033.
Akeso Announced Completion of Patient Enrollment in Phase 3 Trial of Ivonescimab (PD-1/VEGF) versus Pembrolizumab in First-line PD-L1 Positive Advanced NSCLC
Akeso announced completion of patient enrollment in a head-to-head study of ivonescimab (AK112, PD-1/VEGF bispecific antibody) compared with pembrolizumab as first-line treatment for patients.
HanchorBio and Henlius Announce Strategic Collaboration to Develop Innovative Immunotherapies
The collaboration aims to expand the application of each company's platform by developing novel cancer immunotherapies, including those tumors resistant to anti-PD-1/L1 immunotherapies, to accelerate their respective pipeline of innovative immunotherapy medicines.
Sinovac Confirms Receipt of an Unsolicited Partial Tender Offer
Sinovac confirmed today that it is aware of an unsolicited partial tender offer from Alternative Liquidity Index LP to purchase up to a maximum of 10,000,000 shares of the Company, representing approximately 10.05% of the Company’s outstanding shares, for $0.03 per share in cash.
HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib.
Epigenic Therapeutics Announces $32 Million in Series A Funding to Bring Breakthrough Epigenome Medicine to Clinical Development
Epigenic Therapeutics, a leading biotechnology company dedicated to developing next-generation gene modulation therapy utilizing epigenome regulation to treat prevalent diseases, today announced that it has raised $32 million in Series A round of financing.
CARsgen and Moderna to evaluate CT041 in combo with an mRNA cancer vaccine
US mRNA specialist Moderna (Nasdaq: MRNA) saw its shares close up 9.3% at $111.08 on Monday after the announcement of a collaboration agreement to investigate Shanghai, China-based CARsgen Therapeutics’ (2171: HK) investigational Claudin18.2 CAR T-cell product candidate (CT041) in combination with Moderna’s investigational Claudin18.2 mRNA cancer vaccine.
