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BioWorld - Wednesday, May 6, 2026
Home » Topics » Regulatory » NMPA

NMPA
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HKEX exterior

Inhalation drug developer CF Pharmtech raises $78M in Hong Kong IPO

Oct. 14, 2025
By Marian (YoonJee) Chu
No Comments
CF Pharmtech Inc. raised HK$607.67 million (US$78.12 million) through the sale of 41.19 million H shares on the Hong Kong Stock Exchange (HKEX) Oct. 8. The proceeds will be used to advance the Suzhou, China-based drug developer’s portfolio of inhalation candidates for respiratory diseases.
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HKEX exterior

Inhalation drug developer CF Pharmtech raises $78M in Hong Kong IPO

Oct. 13, 2025
By Marian (YoonJee) Chu
No Comments
CF Pharmtech Inc. raised HK$607.67 million (US$78.12 million) through the sale of 41.19 million H shares on the Hong Kong Stock Exchange (HKEX) Oct. 8. The proceeds will be used to advance the Suzhou, China-based drug developer’s portfolio of inhalation candidates for respiratory diseases.
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Radiotherapy of cancer
Cancer

Biokin’s [177Lu]-BL-ARC001 cleared for clinical trials in China

Oct. 13, 2025
No Comments
Sichuan Biokin Pharmaceutical Co. Ltd. has gained clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials with [177Lu]-BL-ARC001 injection.
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3D map of China
Asia-Pacific in the spotlight

China a great AI med-tech market, but premarket review unpredictable

Sep. 23, 2025
By Mark McCarty
China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.
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IPO, coins, financial chart

Genfleet raises $234M with Hong Kong IPO

Sep. 23, 2025
By Marian (YoonJee) Chu
No Comments
Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44.00 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price.
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IPO, coins, financial chart

Genfleet raises $234M with Hong Kong IPO

Sep. 19, 2025
By Marian (YoonJee) Chu
No Comments
Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44.00 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price.
Read More
3D map of China
Asia-Pacific in the spotlight

China a great AI med-tech market, but premarket review unpredictable

Sep. 17, 2025
By Mark McCarty
China’s National Medical Products Administration is arguably more active than regulatory agencies in many nations in advancing guidance for AI in medical technology, but Chang-Hong Whitney, President/CEO of Whitney Consulting Ltd., told BioWorld that the premarket review process still carries some unpredictability.
Read More
Colorized scanning electron micrograph of human respiratory syncytial virus.
Infection

CSPC’s SYH-2066 gains trial clearance in China for RSV

Sep. 15, 2025
No Comments
CSPC Pharmaceutical Group Ltd.’s SYH-2066 tablets has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials for respiratory infections caused by respiratory syncytial virus (RSV).
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Globe isolated on white background with focus on Asia and Australia

Malaysia MDA strengthens regulatory ties with Singapore, China

Aug. 26, 2025
By Marian (YoonJee) Chu
The Medical Device Authority of Malaysia reported on Aug. 22 the piloting of a bilateral medical device approval program with Singapore to streamline the review and launch of medical devices in both countries.
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Remegen’s telitacicept meets phase III endpoints in Sjögren's

Aug. 19, 2025
By Tamra Sami
No Comments
Remegen Co. Ltd.’s telitacicept (RC-18) met the primary endpoint in a phase III trial for treating primary Sjögren's syndrome (pSS), and the company plans to submit a BLA to China’s National Medical Products Administration (NMPA) on the data.
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