DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer

Shots: China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs…

ByPrince Giri10 hours ago

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GSK’s Exdensur (Depemokimab) Receives the NMPA Approval for CRSwNP

Shots: The NMPA has approved Exdensur as an add-on therapy for adults with CRSwNP for whom therapy with systemic corticosteroids & /or surgery do not provide adequate disease control, based on P-III (ANCHOR 1 & 2) trials The ANCHOR-1 & ANCHOR-2 trial assessed Exdensur(Q6M)+ intranasal corticosteroids (SoC) vs PBO + SoC in 271 & 257 pts,…

ByRidhi Rastogi2 days ago

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Henlius Receives the NMPA IND Clearance for HLX319 (Biosimilar, Phesgo)

Shots: The Chinese NMPA has granted IND clearance to HLX319, a biosimilar version of Phesgo (pertuzumab, trastuzumab & hyaluronidase), for neoadj./adj. treatment of HER2+ early or locally advanced breast cancer, as well as for the treatment of metastatic breast cancer Pertuzumab & trastuzumab in HLX319 are Henlius’ HLX11 & Hanquyou, respectively, with HLX11 under review…

ByRidhi RastogiApril 3, 2026

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GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma

Shots: The Chinese NMPA has approved Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) characterised by an eosinophilic phenotype based on P-III (SWIFT-1: n=382) & (SWIFT-2: n=380) trials Exdensur reduced asthma exacerbations by 58% (SWIFT-1) & 48% (SWIFT-2) over 52wks., with results in Chinese pts (n=58, SWIFT-1) consistent with the overall population. Pooled data…

ByRidhi RastogiApril 1, 2026

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Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)

Shots: The Chinese NMPA has granted IND approval to HLX18, a biosimilar version of Opdivo (nivolumab) for the treatment of certain resected solid tumors following the US FDA IND clearance Additionally, HLX17 (biosimilar, Keytruda) & HLX13 (biosimilar, Yervoy) are under P-I trials with first patient dosing completed, while the IND for HLX15-SC (biosimilar, Darzalex), was…

ByRidhi RastogiMarch 23, 2026

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Innovent Receives the NMPA Approval for Jaypirca to Treat R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

Shots: The Chinese NMPA has approved Jaypirca (pirtobrutinib) for the treatment of adults with r/r CLL/SLL after ≥1L of systemic therapy incl. a BTK inhibitor Approval was based on the P-III (BRUIN CLL‑321) study assessing Jaypirca monotx. (200mg, PO, QD) vs investigator’s choice of IdelaR or BR in 238 previously treated pts with r/r CLL/SLL Trial…

ByRidhi RastogiMarch 3, 2026

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GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

Shots: The Chinese NMPA has accepted NDA & granted priority review to linerixibat, an IBAT inhibitor, for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) pts; regulatory review is ongoing in the US, EU, UK & Canada NDA was supported by P-III (GLISTEN) trial assessing linerixibat (40mg) vs PBO to treat PBC pts…

ByRidhi RastogiFebruary 26, 2026

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NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

Shots: The Chinese NMPA has accepted the application of Arexvy RSV vaccine for the prevention of LRTD caused by respiratory syncytial virus (RSV) in adults aged ≥60yrs.; regulatory decision is expected by 2027 Submission was based on extensive clinical data, incl. results from the P-III trial assessing safety & immunogenicity of Arexvy in adults (≥60yrs.)…

ByRidhi RastogiFebruary 10, 2026

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Akeso’s Ivonescimab + CT Receives the NMPA Breakthrough Therapy Designation for Biliary Tract Cancer

Shots: The Chinese NMPA has granted BTD to ivonescimab + CT for the 1L treatment of advanced biliary tract cancer (BTC) Ivonescimab is being assessed in the fully-enrolled P-III (AK112-309/HARMONi-GI1) in combination with CT for the 1L treatment of advanced BTC The P-Ib/II trial data presented at ASCO 2024 showed ivonescimab plus CT showed an…

ByRidhi RastogiFebruary 6, 2026

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Kelun-Biotech Reports NMPA Approval of Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer

Shots: The Chinese NMPA has approved sacituzumab tirumotecan for the treatment of adults with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine therapy & ≥1L of CT in an advanced setting Approval was based on the P-III (OptiTROP-Breast02) trial assessing sac-TMT vs CT for the…

ByRidhi RastogiFebruary 6, 2026

DualityBio Reports China NMPA Acceptance of BLA for Trastuzumab Pamirtecan in Metastatic HER2+ Breast Cancer

GSK’s Exdensur (Depemokimab) Receives the NMPA Approval for CRSwNP

Henlius Receives the NMPA IND Clearance for HLX319 (Biosimilar, Phesgo)

GSK Reports the NMPA Approval of Exdensur (Depemokimab) for Severe Asthma

Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)

Innovent Receives the NMPA Approval for Jaypirca to Treat R/R Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (CLL/SLL)

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

Akeso’s Ivonescimab + CT Receives the NMPA Breakthrough Therapy Designation for Biliary Tract Cancer

Kelun-Biotech Reports NMPA Approval of Sacituzumab Tirumotecan for HR+/HER2- Breast Cancer

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