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BioWorld - Wednesday, June 25, 2025
Home » Topics » Regulatory » NMPA

NMPA
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Illustration of kidneys floating over gloved hand
Nephrology

Sanegene Bio’s SGB-3383 cleared to enter clinic in China for complement-mediated kidney diseases

May 20, 2025
No Comments
Suzhou Sanegene Bio Inc. has gained clinical trial approval in China for SGB-3383 for the treatment of complement-mediated kidney diseases, including IgA nephropathy, C3 glomerulopathy, immune complex-mediated membranoproliferative glomerulonephritis and atypical hemolytic uremic syndrome.
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HKEX on phone, digital stock chart

Hengrui to raise up to $1.27B in Hong Kong listing

May 15, 2025
By Tamra Sami
No Comments
Hengrui Pharmaceuticals Co. Ltd. announced a global offering on the Hong Kong Stock Exchange to raise up to $1.27 billion to advance its growing pipeline focused on oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience.
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Illustration of siRNA structure

Sirius bags $50M series B2 for cardiovascular siRNA pipeline

May 13, 2025
By Marian (YoonJee) Chu
No Comments
Sirius Therapeutics Inc. raised nearly $50 million in a series B2 financing round May 9 to support its pipeline of small interfering RNA (siRNA) molecules for cardiovascular disease indications. SRSD-107, a long-acting Factor XI anticoagulant for thromboembolic disorders, is its lead candidate waiting on EMA clearance to begin a phase II study in Europe. 
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Disitamab vedotin

China’s NMPA gives thumbs up to Remegen’s ADC targeting HER2

May 13, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration has approved Remegen Co. Ltd.’s antibody-drug conjugate (ADC), disitamab vedotin (RC-48), for treatment of HER2-positive advanced breast cancer in patients with liver metastasis.
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Illustration of siRNA structure

Sirius bags $50M series B2 for cardiovascular siRNA pipeline

May 12, 2025
By Marian (YoonJee) Chu
No Comments
Sirius Therapeutics Inc. raised nearly $50 million in a series B2 financing round May 9 to support its pipeline of small interfering RNA (siRNA) molecules for cardiovascular disease indications. SRSD-107, a long-acting Factor XI anticoagulant for thromboembolic disorders, is its lead candidate waiting on EMA clearance to begin a phase II study in Europe. 
Read More
IPO, coins, financial chart

China pharma migration: Hengrui greenlighted for Hong Kong IPO

April 29, 2025
By Marian (YoonJee) Chu
Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.
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Handshake with digital globe overlay

Chinabio 2025: Europe-China pharma deals rise as US markets shut

April 29, 2025
By Marian (YoonJee) Chu
Europe was a bigger counterpart to China in pharmaceutical dealmaking than the U.S. last year, speakers at Chinabio Partnering Forum said April 23, and the trend is likely to continue in 2025 with the shuttering of U.S. capital and volatility ailing global markets.
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China adds Ascentage's lisaftoclax, olverembatinib to guidelines

April 29, 2025
By Tamra Sami
Ascentage Pharma Group Corp. Ltd. said two of its novel candidates have been included in the 2025 Chinese Society of Clinical Oncology Guidelines, including its in-house developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which is under review in China and could be the first domestically approved Bcl-2 inhibitor and the second global approval.
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IPO, coins, financial chart

China pharma migration: Hengrui greenlighted for Hong Kong IPO

April 28, 2025
By Marian (YoonJee) Chu
Jiangsu Hengrui Pharmaceuticals Co. Ltd. is the latest mainland China pharmaceutical company to seek a capital raise on the Hong Kong stock exchange, winning clearance April 28 from the China Securities Regulatory Commission to float new H-shares.
Read More
Blood pressure monitor
Cardiovascular

Chinese IND clearance for Rona′s AGT-targeting siRNA drug for hypertension

April 25, 2025
Rona Therapeutics Co. Ltd. has obtained IND clearance from China′s National Medical Products Administration (NMPA) for RN-1871, a small interfering RNA (siRNA) drug targeting angiotensinogen (AGT) for hypertension.
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