BioPharma APAC - Leading Source of Biopharmaceutical Intelligence in Asia Pacific

BioPharma Drug Approval

ACG Leads the Charge in Vegan Capsules: Innovation, Certification, and the Future of Sustainable Pharma

As the demand for plant-based and clean-label pharmaceutical solutions grows, ACG Capsules has positioned itself at the forefront of innovation with its ve...

March 06, 2025 | Interview

Celltrion Secures FDA Approval for STOBOCLO® and OSENVELT® as Biosimilars to PROLIA® and XGEVA®

STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA®&nbs...

March 05, 2025 | News

Avecho and Sandoz Ink 10-Year Deal for Australia’s First Pharmaceutical CBD Capsule for Insomnia

Avecho and Sandoz sign an exclusive ten-year development and license agreement ("Agreement") for Avecho's pharmaceutical cannabidiol capsule for insomnia...

March 04, 2025 | News

China Fapon Biopharma secures US FDA IND approval for FP008 a first-in-class immunocytokine for resistant solid tumors

Fapon Biopharma, a biotech innovator in developing therapeutic antibodies and fusion proteins, is pleased to announce that the U.S. Food and Drug Administr...

March 03, 2025 | News

Fosun Pharma Secures NMPA Approval for Tenapanor, Bringing New Hope to Dialysis Patients in China

Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma; stock code: 600196.SH, 02196.HK) announced that its holding subsidiary, Shanghai Fosun Pharm...

February 27, 2025 | News

MicuRx’s MRX-4 and Contezolid Show Favorable Safety and Efficacy in Phase III Trial for Diabetic Foot Infections

Data Monitoring Committee (DMC) has completed the first safety and efficacy assessment of the global Phase III clinical trial, recommending continued pro...

February 26, 2025 | News

Telix’s Kidney Cancer Imaging Agent Gains FDA Priority Review, Eyes 2025 Launch

Telix Pharmaceuticals has announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for TLX25...

February 26, 2025 | News

Chime Biologics and Mabgeek Advance MG-K10 to U.S. Phase III Trials for Atopic Dermatitis and Asthma

Chime Biologics, a leading global CDMO that enables its partners' success in biologics, announced its continued collaboration with Mabgeek ...

February 24, 2025 | News

Australia Grants First Global Market Approval for YORVIPATH® to Treat Chronic Hypoparathyroidism

YORVIPATH® (palopegteriparatide) is now registered by the Therapeutic Goods Administration (TGA) for the treatment of chronic hypoparathyroidism...

February 21, 2025 | News

Ascletis’ ASC30 Oral Tablet Shows Promising Weight Loss in U.S. Phase Ib Obesity Trial

- ASC30 oral once-daily tablet demonstrated a 6.3% mean body weight reduction from baseline after 28-day treatment in multiple ascendi...

February 20, 2025 | News

Australia’s Clarity Pharmaceuticals Secures FDA Fast Track for 67Cu-SAR-bisPSMA in Prostate Cancer

Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or "Company"), a clinical-stage radiopharmaceutical company with a mission to develop next-generation pr...

February 20, 2025 | News

VIVOZON’s UNAFRA Inj. Secures MFDS Approval as South Korea’s First First-in-Class Non-Opioid Analgesic

VIVOZON Pharmaceutical announced that its non-opioid analgesic, UNAFRA Inj., was approved on December 12, 2024. (active ingredient: Opiranserin H...

February 19, 2025 | News

TAHO Pharmaceuticals’ Apixaban Oral Dissolving Film Shows Positive Results in Pivotal Study

TAHO Pharmaceuticals announces positive preliminary results from the pivotal study of TAH3311, the world's first Apixaban oral dissolving film (ODF). The s...

February 18, 2025 | News

Kexing Biopharm Receives FDA Approval for Clinical Trials of GB05 Inhalation Therapy for Pediatric RSV Infections

Kexing Biopharm Co., Ltd. (Stock Code: 688136.SH) recently announced that the Investigational New Drug Application (IND) of GB05, Human Interferon α1...

February 17, 2025 | News

Stay Connected