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Home » Topics » Regulatory » NMPA

NMPA
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3D map of China

Cryofocus’ asthma device wins FDA breakthrough label

July 25, 2025
By Marian (YoonJee) Chu
Cryofocus Medtech (Shanghai) Co. Ltd. received U.S. FDA breakthrough device designation on July 24 for its cryoablation system for asthma. The Chinese med-tech’s stock (HKEX:6922) rose near 20% over two consecutive days on the Hong Kong Stock Exchange with the news, increasing from HK$5.00 ($.64) July 23 to HK$5.98 nearing the close of trading on July 25.
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Skin irritation on hands

Livzon’s IL-17A/F meets phase III endpoints in plaque psoriasis ​

July 22, 2025
By Tamra Sami
No Comments
Livzon Mabpharm Inc.’s anti-IL-17A/F monoclonal antibody, LZM-012, met the primary endpoint in a phase III trial in moderate to severe plaque psoriasis. Conducted at Fudan University’s Huashan Hospital, the phase III multicenter, randomized, double-blind, active-controlled (secukinumab) trial enrolled 926 patients with moderate to severe plaque psoriasis.
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Circode executives
Newco news

Circode applies circRNA to heart disease drug R&D, in vivo CAR T

July 15, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
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Wooden stamp with China flag

China approves Ascentage’s lisaftoclax, its first Bcl-2 inhibitor

July 15, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration approved Ascentage Pharma Group Corp. Ltd.’s Bcl-2 selective inhibitor lisaftoclax (APG-2575) for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who previously received at least one systemic therapy including Bruton’s tyrosine kinase inhibitors.
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Wooden stamp with China flag

China approves Ascentage’s lisaftoclax, its first Bcl-2 inhibitor

July 14, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration approved Ascentage Pharma Group Corp. Ltd.’s Bcl-2 selective inhibitor lisaftoclax (APG-2575) for treating adults with chronic lymphocytic leukemia/small lymphocytic lymphoma who previously received at least one systemic therapy including Bruton’s tyrosine kinase inhibitors.
Read More
Circode executives
Newco news

Circode applies circRNA to heart disease drug R&D, in vivo CAR T

July 11, 2025
By Marian (YoonJee) Chu
No Comments
Shanghai Circode Biomed Co. Ltd. is set to begin clinical trials of HM-2002, a circular RNA (circRNA)-based drug for ischemic heart disease, having gained IND clearance in China Jan. 10 and the U.S. on May 30, Circode CEO Chenxiang Tang recently told BioWorld.
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China approves Simcere’s suvemcitug for ovarian cancer

July 8, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance.
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China approves Simcere’s suvemcitug for ovarian cancer

July 7, 2025
By Tamra Sami
No Comments
China’s National Medical Products Administration gave the green light to Simcere Pharmaceutical Group Ltd.’s Enzeshu (suvemcitug) for treating recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received at least one systemic therapy after platinum resistance.
Read More
3D rendering of an antibody drug conjugate
Immuno-oncology

Innocare’s ICP-B794 gains IND clearance in China

July 4, 2025
No Comments
Innocare Pharma Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) to initiate a clinical trial of the B7-H3 targeted antibody-drug conjugate.
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Deal handshake with coin, chart background

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

July 1, 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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