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BioWorld - Sunday, December 14, 2025
Home » Topics » Regulatory » NMPA

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Woman receiving chemotherapy
Endocrine/metabolic

Kexing’s GB-18 receives IND clearances in China and US for cancer cachexia

May 29, 2025
No Comments
Kexing Biopharm Co. Ltd. has announced IND clearances this month by China’s National Medical Products Administration (NMPA) and the U.S. FDA for GB-18, a biologic product for the treatment of cancer cachexia.
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HKEX on phone, digital stock chart

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

May 20, 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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3d rendering of bispecific antibodies

Pfizer bets $6B+ on 3Sbio’s bispecific PD-1/VEGF antibody

May 20, 2025
By Marian (YoonJee) Chu
No Comments
Pfizer Inc. is paying $1.25 billion up front and up to $4.8 billion in milestone payments to gain global, ex-China rights to SSGJ-707, a PD-1/VEGF bispecific antibody from 3Sbio Inc. that recently won China clearance for a phase III study in lung cancer as a potential first-line monotherapy. Announced after U.S. market hours May 19, the exclusive agreement for SSGJ-707 spells up to $6.15 billion combined for Shenyang, China-based 3Sbio, along with separate tiered double-digit royalty payments on sales of SSGJ-707, if approved.
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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.
Read More
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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