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Home » Topics » BioWorld Asia, Regulatory

BioWorld Asia, Regulatory
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Rexulti

Adcom agrees with FDA: Otsuka’s PTSD treatment needs more study

July 22, 2025
By Lee Landenberger
No Comments
In a 10-1 vote, the U.S. FDA’s Psychopharmacologic Drugs Advisory Committee said Otsuka Pharmaceutical Co. Ltd.’s studies of its combination post-traumatic stress disorder (PTSD) treatment did not show enough efficacy. Had the adcom felt otherwise, the path may have been smoother for a new treatment in an indication that hasn’t seen regulatory advancement in decades. The committee’s conclusion, however, is not binding on the FDA, which will make its own decision whether to approve.
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Coin inserted into Australian map

Australia awards AU$100M in grants to biopharma/med-tech incubators

July 22, 2025
By Tamra Sami
No Comments
The Australian government has awarded nearly AU$100 million (US$64.65 million) in grant funding to three biopharma/med-tech incubators to support emerging Australian biopharma and med-tech startups.
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Blue injector pens

Biocon wins first FDA interchangeable label of Novolog biosimilar

July 22, 2025
By Marian (YoonJee) Chu
No Comments
The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a rapid-acting diabetes medication.
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June FDA approvals jump, led by three new NMEs

July 22, 2025
By Amanda Lanier
No Comments

The U.S. FDA approved 22 drugs in June, tying with March for the highest number of approvals and a jump from 15 approvals in May. The FDA approved 107 drugs in the first half (H1) of 2025, making it the third-highest total for this period in BioWorld’s records, trailing 118 approvals in 2024 and 108 in 2020.


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Wooden stamp with China flag

China approves Ascentage’s lisaftoclax, its first Bcl-2 inhibitor

July 15, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration approved Ascentage Pharma Group Corp. Ltd.’s Bcl-2 selective inhibitor lisaftoclax (APG-2575) for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who previously received at least one systemic therapy including Bruton’s tyrosine kinase inhibitors.
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China approves Simcere’s suvemcitug for ovarian cancer

July 8, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance.
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Xray showing lung cancer on tablet

FDA approves Dizal’s sunvozertinib for metastatic non-small-cell lung cancer

July 8, 2025
By Tamra Sami
No Comments
Four days ahead of its July 7 PDUFA date, the U.S. FDA granted accelerated approval to Dizal (Jiangsu) Pharmaceutical Co. Ltd.’s sunvozertinib (DZD-9008), branded as Zegfrovy, for treating adults with locally advanced or metastatic non-small-cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations following platinum-based chemotherapy.
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Wuhan Healthgen gets chance at China IPO with SSE market reforms

July 8, 2025
By Marian (YoonJee) Chu
No Comments
Wuhan Healthgen Biotechnology Co. Ltd. gained clearance from the Shanghai Stock Exchange July 1 to list under a recently reinstated IPO growth tier geared towards supporting “unprofitable” biotechnology firms.
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CAR T cell attacking cancer cells

China’s NMPA accepts Carsgen’s NDA for Claudin18.2-targeted CAR T

July 1, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration (NMPA) has accepted for review Carsgen Therapeutics Holdings Ltd.’s NDA for satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T candidate targeting Claudin18.2 for treating Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. Just one day earlier, Carsgen announced that it had submitted the satri-cel NDA to the NMPA.
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Hong Kong Department of Health director and assistant directors

Hong Kong to set up CMPR as medical products authority by 2026

July 1, 2025
By Marian (YoonJee) Chu
No Comments
Hong Kong’s Department of Health (DH) announced plans to establish a new medical products regulatory agency called the Hong Kong Centre for Medical Products Regulation (CMPR) by the end of 2026.
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