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Home » Topics » Regulatory » NMPA

NMPA
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Mazdutide injection device and product packaging

China clears mazdutide as first dual GCG/GLP-1RA for weight loss

June 30, 2025
By Marian (YoonJee) Chu
No Comments
Innovent Biologics Inc. announced June 27 that it gained National Medical Products Administration’s (NMPA) approval of mazdutide as a new weight loss therapy for obese or overweight patients in China. Mazdutide is a dual glucagon/glucagon-like peptide-1 (GCG/GLP-1) receptor agonist originally discovered by Eli Lilly and Co., of Indianapolis.
Read More
CAR T cell attacking cancer cells

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

June 27, 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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Deal handshake with coin, chart background

After axing 95% workforce, Vor bets $4B+ on Remegen’s telitacicept

June 26, 2025
By Marian (YoonJee) Chu
No Comments
Just a month after laying off 147 employees and announcing plans to mull “strategic alternatives,” Vor Biopharma Inc. reported raising $175 million in private placement in public equity financing and inking a new $4.23 billion license deal for Yantai Rongchang Biotechnologies (Remegen) Co. Ltd.’s telitacicept, a dual-target fusion protein drug approved in China for three autoimmune indications. The news was disclosed after U.S. market hours June 25. Vor’s shares (NASDAQ:VOR) gained 34 cents, or 60.5%, to close June 26 at 89 cents. The company’s shares had risen for eight consecutive trading days since June 17.
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Multiple myeloma illustration

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

June 17, 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.
Read More
Red and blue bispecific antibodies

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

June 17, 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.
Read More
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.
Read More
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.
Read More
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.
Read More

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.
Read More

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.
Read More
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