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BioWorld - Sunday, December 21, 2025
Home » Topics » Regulatory » NMPA

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Multiple myeloma illustration

Cullinan deals $712M to test Genrix bispecific TCE in autoimmune

June 12, 2025
By Marian (YoonJee) Chu
No Comments
Cullinan Therapeutics Inc. swept up ex-China rights to a multiple myeloma (MM)-targeting BCMAxCD3 bispecific T-cell engager (TCE) velinotamig from Chongqing Genrix Biopharmaceutical Co. Ltd. via a potential $712 million deal June 4. The plan is to repurpose the cancer drug to autoimmune disease.
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Red and blue bispecific antibodies

3Sbio revs on with phase II data in tight PD-1/VEGF bispecific race

June 11, 2025
By Marian (YoonJee) Chu
No Comments
3Sbio Inc. reported interim phase II study results of its PD-1/VEGF bispecific antibody, SSGJ-707 – a “fabulous” asset, according to Pfizer Inc. CEO Albert Bourla, that landed in Pfizer’s cancer arsenal via a potential $6 billion deal in May, of which $1.2 billion was paid up front.
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Eye wireframe illustration
Ocular

Chinese IND clearance for anti-IGF-1R antibody NTB-003 for thyroid eye disease

June 5, 2025
No Comments
Biocytogen Pharmaceuticals (Beijing) Co. Ltd. and Nanjing Chia Tai Tianqing Pharmaceutical Co. Ltd. have announced IND clearance by China’s National Medical Products Administration (NMPA) for NTB-003 (formerly BCG-009) for thyroid eye disease.
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China clears Mabwell’s Mailisheng injection to treat neutropenia

June 3, 2025
By Marian (YoonJee) Chu
No Comments
Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy.
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China clears Mabwell’s Mailisheng injection to treat neutropenia

June 2, 2025
By Marian (YoonJee) Chu
No Comments
Mabwell (Shanghai) Bioscience Co. Ltd. on May 30 gained Chinese approval of Mailisheng (albipagrastim alfa; 8MW-0511) as a subcutaneous injection to treat febrile neutropenia induced by myelosuppressive anticancer treatment, such as radiotherapy and chemotherapy.
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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.
Read More
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
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