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Zymeworks
NEWS

Zymeworks’ Zanidatamab Receives the NMPA’s Conditional Approval for the Treatment of Biliary Tract Cancer

Shots: The NMPA has granted conditional approval to zanidatamab for the treatment of pts with previously treated, inoperable or metastatic HER2+ biliary tract cancer (BTC) following the CHMP’s positive opinion in Apr 2025 Approval was based on P-IIb (HERIZON-BTC-01) trial, which assessed anti-tumor activity of zanidatamab monotx. in HER2+ inoperable & advanced or metastatic BTC Approval…
May 30, 2025

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INSIGHTS+

New Drug Designations – April 2025  

Shots:     PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada and NMPA   The April 2025 report covers designations granted to 36 drugs and 6 medical devices, spanning 14 small molecules, 3 biologics, 11 cell and gene therapies & 6 medical devices among…
May 27, 2025

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Remegen
NEWS

RemeGen’s Telitacicept Receives the NMPA’s Approval for Generalized Myasthenia Gravis (gMG)

Shots: The NMPA has approved telitacicept for the treatment of AChR antibody-positive gMG in combination with standard therapies In P-III trial for gMG, telitacicept demonstrated favorable efficacy vs PBO, with 98.1% vs 12% pts achieving ≥3-point MG-ADL reduction (-5.74 vs -0.91) as well as 87% vs 16% pts having ≥5-point QMG reduction (-8.66 vs -2.27) at…
May 27, 2025

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Gyre Therapeutics
NEWS

Gyre Therapeutics Releases P-III Trial Findings on Hydronidone for Chronic Hepatitis B-Associated Liver Fibrosis

Shots: Gyre Therapeutics has reported P-III trial data assessing Hydronidone (270mg, QD, PO) + entecavir (n=123) vs PBO + entecavir (n=124) in 248 Chinese pts with chronic hepatitis B-associated liver fibrosis for 52wks.; 1 untreated subject was excluded from analysis Trial met its 1EP, with 52.85% vs 29.84% achieving ≥1-stage fibrosis regression (Ishak score) & 2EP,…
May 23, 2025

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Innocare Pharma
NEWS

China’s NMPA Grants Approval to InnoCare Pharma’s Minjuvi + Lenalidomide to Treat R/R DLBCL

Shots: InnoCare Pharma has approved Minjuvi (tafasitamab) + Lenalidomide, followed by Minjuvi monotx., for treating adult pts. with r/r diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT) Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting immunotherapy, combined with lenalidomide, is already approved for treating eligible DLBCL pts. in Hong Kong, Macau,…
May 21, 2025

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Cytokinetics
NEWS

Cytokinetics Reports P-III (MAPLE-HCM) Trial Data of Aficamten for Obstructive Hypertrophic Cardiomyopathy

Shots: Cytokinetics has reported P-III (MAPLE-HCM) trial data assessing aficamten vs SoC metoprolol in pts (n=175) with symptomatic obstructive hypertrophic cardiomyopathy (HCM); regulatory review is ongoing in the US FDA (PDUFA: Dec 26, 2025) & EMA, with its NDA also under NMPA's priority review  The trial met its 1EP, showing superior improvement in peak oxygen…
May 14, 2025

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Everest Medicines
NEWS

China’s NMPA Grants Full Approval to Everest Medicines’ Nefecon for the Treatment of Primary IgAN in Adults at Risk of Disease Progression

Shots: China’s NMPA has granted full approval to sNDA of Nefecon to reduce kidney function loss in adults with primary IgAN at risk of disease progression, regardless of their proteinuria levels Approval was based on global P-III (NefIgArd) trial assessing Nefecon (16mg, QD, PO) vs PBO in above pts on RASi therapy over 2yrs. (9mos.…
May 8, 2025

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Insight+_Ridhi Rastogi
INSIGHTS+

New Drug Designations – March 2025 

Shots:      PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, and NMPA    The March 2025 report covers designations granted to 37 drugs and 3 medical devices, spanning 11 small molecules, 10 biologics, 10 cell and gene therapies & 3 medical devices among…
April 29, 2025

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Rona Therapeutics
NEWS

Rona Therapeutics Reports NMPA’s IND Acceptance of RN1871 for Hypertension

Shots: China’s NMPA has accepted IND application for RN1871 for hypertension, with Rona planning to advance it in P-I trial to assess its safety, PK, & preliminary efficacy in humans Preclinical studies have demonstrated AGT suppression & sustained blood pressure control, with reduced dosing frequency of RN1871 RN1871 is engineered to suppress AGT mRNA expression in the…
April 22, 2025

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