Pharmaceuticals

First Participant Dosed in First-in-Human Phase 1 Study of GZC8072, a Novel Ultra-Long-Acting Once-Weekly Oral Peptide GLP-1 RA

BEIJING and BRIDGEWATER, Mass., Sept. 9, 2026 /PRNewswire/ -- Gan&Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan&Lee) announced that the first participant has been dosed in a First-In-Human (FIH) Phase 1 study of GZC8072 tablets, a novel ultra-long-acting oral peptide GLP-1 RA form...

2026-09-09 21:00 4555

Moonwalk Biosciences Announces $70 Million Series B: NYSE Content Update

NYSE issues a pre-market daily advisory direct from the trading floor. NEW YORK, Sept. 9, 2026 /PRNewswire/ -- The New York Stock Exchange (NYSE) provides a daily pre-market update directly from the NYSE Trading Floor. Access today's NYSE Pre-market update for market insights before trading begin...

2026-09-09 20:56 6623

Full-Life Technologies Announces U.S. FDA IND Clearance and Australian Regulatory Clearance for [²²⁵Ac]Ac-FL-261 Phase 1 Clinical Trial

LONDON, Sept. 9, 2026 /PRNewswire/ -- Full-Life Technologies ("Full-Life", the "Company"), a privately held, fully integrated, clinical-stage actinium-based global radiopharmaceutical company, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the Company's Investigati...

2026-09-09 20:25 2624

Transcenta Therapeutics and WuXi Biologics Enter into Strategic Collaboration to Accelerate Commercialization of HiCB Continuous Bioprocessing Technologies

PRINCETON, N.J. and SUZHOU, China, Sept. 9, 2026 /PRNewswire/ -- Transcenta Therapeutics (HKEX: 06628), a global clinical-stage biopharmaceutical company with fully integrated capabilities in discovery, R&D and process development of antibody-based therapeutics, today announced that it and its su...

2026-09-09 20:00 2146

Daesang Targets Global Pharmaceutical Amino Acid Market, Building on 70 Years of Fermentation Technology

* Leverages fermentation know-how developed through MIWON to expand beyond general-purpose amino acids into high-value pharmaceutical materials * Acquires Germany-based AMINO GmbH, gaining purification technology, European regulatory expertise, and a global customer network SEOUL, South Kore...

2026-09-09 20:00 3587

Kazia Therapeutics Announces First Patient Dosed in PNOC035 Clinical Study Evaluating Paxalisib for Recurrent Pediatric AT/RT Brain Cancer

Multicenter study to evaluate paxalisib plus gemcitabine for children and young adults with recurrent or progressive AT/RT, where no approved therapies currently exist SYDNEY, Sept. 9, 2026 /PRNewswire/ -- Kazia Therapeutics Limited

2026-09-09 19:30 2269

Harbour BioMed Partner, Solstice Oncology, announces $225 Million Series A Financing to Advance Porustobart, a Neoadjuvant Immuno-Oncology Therapy

* Porustobart, a second-generation Fc-enhanced CTLA-4 antibody, is being advanced across two clinical indications in the neoadjuvant setting, beginning with MSS clinical stage II-III colon cancer * Phase 2 trial of porustobart for colon cancer will be open for enrollment early in the fourth q...

2026-09-09 19:12 2516

HanchorBio Reaches Clinical Milestone for HCB101 as US FDA Allows Continued Treatment for Phase 1 Patient Experiencing Clinical Benefit

HCB101 represents the first known U.S. Expanded Access case for a SIRPα Fc fusion protein enabling continued therapy beyond the parent study. TAIPEI and SHANGHAI and SAN FRANCISCO, Sept. 9, 2026 /PRNewswire/ -- HanchorBio, Inc. (TWSE: 7827), a global clinical-stage biotechnology company developi...

2026-09-09 18:00 1836

ZAGENO Earns Frost & Sullivan's 2026 North American Life Sciences E‑Commerce Company of the Year Recognition

Honored for transforming life sciences procurement through digital innovation, automation, and a customer-first platform SAN ANTONIO, Sept. 9, 2026 /PRNewswire/ -- Frost & Sullivan

2026-09-09 04:00 2331

Accro Bioscience Announces IND Clearance from NMPA for Phase II/III Clinical Trial of AC-201, a Highly Selective TYK2/JAK1 Inhibitor for the Treatment of Non-Segmental Vitiligo

NEW YORK and SUZHOU, China, Sept. 8, 2026 /PRNewswire/ -- Accro Bioscience (Suzhou) Limited ("Accro") today announced that Shanghai Fosun Pharmaceutical Industrial Development Company Limited ("Fosun Pharma Industrial"), a subsidiary of its partner Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ...

2026-09-08 20:20 1838

HBM9378/WIN378, an Ultra-Long-Acting Antibody Targeting TSLP, Achieves Positive Phase 2 Results in Asthma and Initiates Phase 3 Study

* The POLARIS-1 study enrolled 147 patients with uncontrolled, moderate-to-severe asthma, and the interim analysis was conducted on the first 98 patients. The analysis demonstrated a half-life of up to 75 days, with clinical effects consistent with twice-yearly dosing. * HBM9378/WIN378 produc...

2026-09-08 20:17 2249

Alebund Pharmaceuticals Announces FDA Clearance of IND Application for AP308 for the Treatment of IgA Nephropathy

SHANGHAI, Sept. 8, 2026 /PRNewswire/ -- Alebund Pharmaceuticals (Jiangsu) Limited ("Alebund" or the "Company"; HKEX: 09637), a renal-focused biopharmaceutical company, today announced that it has recently received clearance from the U.S. Food and Drug Administration (FDA) of its Investigational ...

2026-09-08 20:15 1931

Kelun-Biotech's Partner Windward Bio Announces Positive Phase 2 Results of SKB378/WIN378 in Asthma, and Initiates Phase 3 Study

* The POLARIS-1 study enrolled 147 patients with uncontrolled, moderate-to-severe asthma, and the interim analysis was conducted on the first 98 patients. The analysis demonstrated a half-life of up to 75 days, with clinical effects consistent with twice-yearly dosing. * SKB378/WIN378 produce...

2026-09-08 20:02 2184

Ascletis Announces Initiation of Phase I Study in U.S. for Oral Amylin Receptor Peptide Agonist ASC36 for the Treatment of Obesity

- This trial marks the fourth Phase I peptide study for Ascletis this year. - ASC36 oral tablets achieved absolute oral bioavailability of 6% to 8% at steady state in non-human primate (NHP) studies utilizing Ascletis' proprietary Peptide Oral Transport ENhancement Technology (POTENT). - ASC36 o...

2026-09-08 18:10 2292

/C O R R E C T I O N -- GCCL/

In the news release, "GCCL Strengthens Asia-Pacific Presence at Asia Bio Partnering Forum 2026," issued on September 8, 2026 by GCCL over PR Newswire, we are advised by the company that the name "Yoo-Hwa Choi" should read "Yuhwa Choi" throughout the release, as originally issued inadvertently. Co...

2026-09-08 16:05 2554

PT Prodia Diacro Laboratories Receives Frost & Sullivan's 2026 Southeast Asian Contract Research Organization Customer Value Leadership Recognition for Customer-Centric Clinical Research Excellence

Prodia the CRO is recognized for its reliable, integrated clinical research ecosystem, customer-centric delivery model, and commitment to quality, innovation, and long-term sponsor value across Southeast Asia. SAN ANTONIO, Sept. 8, 2026 /PRNewswire/ -- Frost & Sullivan

2026-09-08 13:00 1437

/C O R R E C T I O N -- Wooree Group/

In the news release, Wooree Group Concludes Vitafoods Asia 2026, CEO Ji-yong Yoon Calls for Scientific Validation Standard for Liposome Claims, issued 07-Sep-2026 by Wooree Group over PR Newswire, we are advised by the company that the product name "Harutin" should read "Haroutine" throughout the...

2026-09-08 12:06 4908

Taiwan's HORIEN Accelerates Global Footprint: Achieves Three Thai FDA Class 4 Approvals and Secures U.S. Patent for Biodegradable Ureteral Stent

Market-entry initiative targets qualified Thai distributors across dental, surgical, wound-care, and regenerative medicine channels, while solidifying global IP leadership in advanced urological biomaterials. TAICHUNG, Sept. 8, 2026 /PRNewswire/ -- HORIEN Biochemical Technology Co., Ltd. (TPEx: ...

2026-09-08 10:00 3425

Cell Stem Cell: tBE-mediated Base Editing Therapy Achieves Durable Clinical Remission in Sickle Cell Disease and β-Thalassemia Across Different Genetic Backgrounds

Following 100% transfusion independence in Chinese TDT patients, new study confirms tBE is equally safe and effective for African SCD patients and TDT patients from South/Southeast Asia. SHANGHAI, Sept. 7, 2026 /PRNewswire/ -- On September 7, 2026, Shanghai, Cell Stem Cell published online clini...

2026-09-08 08:00 1922
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