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NEWS

Cytokinetics Reports the CHMP Positive Opinion on Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The CHMP has recommended Cytokinetics’ Myqorzo for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with EC decision expected in Q1’26 Opinion was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by 1.8 vs 0 ml/kg/min, consistent across all subgroups &…
December 15, 2025

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Boehringer Ingelheim
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Boehringer Ingelheim Receives the NMPA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

Shots: The Chinese NMPA has approved Boehringer Ingelheim's Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF) Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, which met its 1EP of reduced FVC at Wk. 52 & showed a significant reduction in death risk   Additionally, Jascayd'ssNDA for PPF is under…
December 10, 2025

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NEWS

Junshi Biosciences Reports NMPA Acceptance of the NDA for Roconkibart (IL-17A) to Treat Moderate to Severe Plaque Psoriasis

Shots: Junshi Biosciences reported that the NMPA has accepted the NDA for roconkibart injection (JS005), for adults with moderate to severe plaque psoriasis eligible for systemic therapy or phototherapy The submission is backed by a multicenter P-III study (n=747) showing significant improvements in PASI 75/90/100 and sPGA 0/1 vs PBO at 12wks., with sustained efficacy…
December 8, 2025

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Innovent
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Innovent Biologics Reports the Chinese NMPA Approval of Pecondle (Picankibart) to Treat Plaque Psoriasis

Shots: The Chinese NMPA has approved Pecondle (picankibart) for the treatment of mod. to sev. plaque psoriasis (PsO) in adults who are candidates for systematic therapy Approval was supported by the P-III (CLEAR-1) trial in Chinese pts with mod. to sev. PsO, where picankibart demonstrated significantly higher PASI 90 (1EP; 80.3% vs 2%) & sPGA 0/1…
November 28, 2025

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INSIGHTS+

New Drug Designations – October 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 October 2025 report covers designations granted to 56 drugs and 9 medical devices, spanning 23 small molecules, 14 biologics, 10 cell and gene therapies & 9 medical devices, among…
November 25, 2025

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Kelun Biotech
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Kelun-Biotech Reports P-III (OptiTROP-Lung05) Trial Data on Sacituzumab Tirumotecan + Keytruda for PD-L1-Positive NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung05) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs Keytruda monotx. as a 1L treatment for PD-L1-positive locally advanced or metastatic NSCLC with PD-L1 TPS ≥1% The trial met its 1EP of improved PFS, as concluded by IDMC & showed a favorable trend in the OS Additionally, the company…
November 25, 2025

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NEWS

Geneseeq’s PanTRKare NTRK Gene Fusion Detection Kit Receives NMPA Approval as Companion Diagnostic

Shots: The Chinese NMPA has approved PanTRKare NTRK1/2/3 Gene Fusion Detection Kit as a companion diagnostic for Roche’s Rozlytrek (entrectinib) The kit was validated through a large-scale study across 33 tumor types & 2,400+ clinical samples, where it demonstrated high accuracy, sensitivity, & reproducibility, with detection of 200+ unique NTRK fusion variants Also, clinical bridging studies…
November 11, 2025

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INSIGHTS+

New Drug Designations – September 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 September 2025 report covers designations granted to 33 drugs and 4 medical devices, spanning 12 small molecules, 6 biologics, 8 cell and gene therapies & 4 medical devices among others  …
October 28, 2025

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