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Home » Topics » Regulatory » NMPA

NMPA
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Mast cell releasing histamine during allergic response
Immune

Longbio’s LP-003 receives NMPA clearance to enter clinic for food allergy

Nov. 26, 2024
Longbio Pharma (Suzhou) Co. Ltd. has obtained IND approval from China’s National Medical Products Administration (NMPA) for LP-003, the company’s next-generation anti-IgE antibody, to enter a clinical trial for the treatment of food allergy.
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NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases

Nov. 26, 2024
By Marian (YoonJee) Chu
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
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NMPA clears Alpha’s oral EGFR-TKI for NSCLC with brain metastases

Nov. 21, 2024
By Marian (YoonJee) Chu
China’s drug regulator approved Alpha Biopharma Ltd.’s EGFR tyrosine kinase inhibitor (TKI), Zorifer (zorifertinib hydrochloride tablets; AZD-3759), as a first-line treatment for EGFR-mutated non-small-cell lung cancer (NSCLC) with brain metastases.
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China’s NMPA accepts Ascentage NDA for Bcl-2 inhibitor lisaftoclax

Nov. 19, 2024
By Tamra Sami
China’s National Medical Products Administration (NMPA) has accepted Ascentage Pharma Group Corp. Ltd.’s NDA for its in-house-developed Bcl-2 selective inhibitor, lisaftoclax (APG-2575), which could be the first domestically approved Bcl-2 inhibitor in China and the second global approval.
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Chinese flag and microscopes
Drug design, drug delivery & technologies

‘A decade of innovation, a decade to come’ for China pharma

Nov. 19, 2024
By Marian (YoonJee) Chu
As China rises to second place, next only to the U.S., for innovative new drugs, a new report by Clarivate – A Decade of Innovation, A Decade to Come – outlines key policy reforms and regulatory, R&D and investment trends driving past and future growth of Chinese biopharmaceuticals.
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Chinese flag and microscopes

‘A decade of innovation, a decade to come’ for China pharma

Nov. 18, 2024
By Marian (YoonJee) Chu
As China rises to second place, next only to the U.S., for innovative new drugs, a new report by Clarivate – A Decade of Innovation, A Decade to Come – outlines key policy reforms and regulatory, R&D and investment trends driving past and future growth of Chinese biopharmaceuticals.
Read More
Woman about to receive a vaccine
Immune

CSPC’s HPV mRNA vaccine candidate cleared to enter clinic in China

Nov. 13, 2024
CSPC Pharmaceutical Group Ltd.’s SYS-6026 has obtained clearance from China’s National Medical Products Administration (NMPA) to enter clinical trials for the treatment of high-grade squamous intraepithelial lesions associated with human papillomavirus (HPV) type 16 or 18.
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Illustration of knee joint, giant cell tumor of bone

Abbisko’s pimicotinib meets endpoints in phase III

Nov. 12, 2024
By Tamra Sami
Abbisko Therapeutics Co. Ltd.’s colony-stimulating factor 1 receptor inhibitor, pimicotinib, met both primary and secondary endpoints in the phase III Maneuver global study evaluating pimicotinib for treatment of tenosynovial giant cell tumor.
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Brain tumor illustration
Cancer

Chipscreen Biosciences’ IND application for CS-231295 accepted by China’s NMPA

Oct. 18, 2024
Shenzhen Chipscreen Biosciences Co. Ltd. has submitted an IND application for CS-231295 tablets for the treatment of tumors, and the application has been accepted by the Center for Drug Evaluation of China’s National Medical Products Administration (NMPA).
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Innocare’s TYK2 inhibitor meets psoriasis endpoints in phase II

Oct. 15, 2024
By Tamra Sami
Innocare Pharma Ltd.’s tyrosine kinase 2 (TYK2) inhibitor, ICP-488, met the primary endpoint in a phase II trial in Chinese patients with moderate to severe plaque psoriasis, and the results clear the way to accelerate clinical development in psoriasis and other autoimmune diseases.
Read More
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