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BioPharma Drug Approval

Antengene Clears U.S. IND for Phase I Trial of ATG-031 Antibody

- ATG-031, discovered and developed in-house by Antengene, is the world's first anti-CD24 antibody to advance to the clinic in oncolog...

May 18, 2023 | News

Antengene Announces NDA Submission for XPOVIO® in Indonesia

"In just six months, we have submitted NDAs for XPOVIO® in three ASEAN countries, Malaysia, Thailand and Indonesia, supporting...

May 17, 2023 | News

Innovent's IBI351 gets NMPA breakthrough designation for advanced colorectal carcinoma

This BTD for IBI351 was based on the pooled analysis of two ongoing clinical trials (NCT05005234, NCT05497336), which include 54 CRC pa...

May 15, 2023 | News

GenAssist's GEN6050 Base Editing Product Submits Pre-IND Application to FDA

Suzhou GenAssist Therapeutic Co.,Ltd recently announced its pre-IND application of their first base editing product, GEN6050 and the acceptance by the FDA....

May 08, 2023 | News

Formosa Pharmaceuticals and AimMax Therapeutics Submit NDA to US FDA for APP13007 for Post-Operative Pain and Inflammation after Ocular Surgery.

This proprietary homogeneous nanosuspension has a solution-like appearance which offers great comfort to the eyes and enhanced drug penetration into ocular...

May 05, 2023 | News

FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy i...

May 04, 2023 | News

FDA Approves Teva and MedinCell's UZEDY™ for Adult Schizophrenia Treatment

This new treatment provides adults living with schizophrenia a long-acting formulation that offers flexible 1- and 2-month dosing intervals1 In a ...

May 01, 2023 | Regulatory

RNAimmune's RV-1730 COVID-19 booster vaccine receives FDA clearance for Phase 1 trial.

The proposed clinical study will involve in an evaluation of RV-1730 for its safety and prophylaxis efficacy against SARS-CoV-2 infection with people...

April 28, 2023 | News

Bridge Biotherapeutics Receives FDA Approval for First-in-Human Study of BBT-207, a 4th Gen EGFR TKI.

The company has been notified by the FDA that the Phase 1/2 clinical trial may proceed The latest preclinical data explored the antitumor effica...

April 24, 2023 | News

Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA

The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023 to allow additional time to review requested u...

April 21, 2023 | News

CARsgen's CT041 receives IND clearance from NMPA for pancreatic cancer therapy.

Dr Raffaele Baffa, Chief Medical Officer of CARsgen, commented that "We are glad to receive the IND clearance from NMPA for the adjuvant treatment of ...

April 20, 2023 | News

Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

"Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of prepara...

April 20, 2023 | News

Crystal Formulation Services Receives China Drug Manufacturing License for Milestone Formulation Capability

Crystal Formulation Services, a subsidiary of Crystal Pharmatech, has achieved an exciting new milestone in its formulation capabilities. The company was r...

April 20, 2023 | News

Biosyngen announces FDA IND approval of its second product for EBV-positive lymphoma

A few months earlier, the Company's first product (BRG01) targeting relapsed/metastatic nasopharyngeal cancer has been granted IND approval by both the US ...

April 19, 2023 | News

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