HUTCHMED Reports NMPA Conditional Approval of Orpathys (Savolitinib) for Gastric Cancer Patients with MET Amplification

Shots: The NMPA has granted conditional approval to Orpathys for the treatment of LA/M gastric cancer or gastroesophageal junction (GC/GEJ) adenocarcinoma pts with MET amplification who have failed ≥2 prior systemic treatments Approval was supported by the P-II trial of Orpathys in GC/GEJ adenocarcinoma pts with MET amplification in China, which showed 32.3% ORR (1EP), & improved 2EPs, incl. 63.1% DCR, 1.4mos.…

ByRidhi RastogiJuly 2, 2026

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Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Shots: The EC has approved Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene Approval was based on the P-III (STEER) trial & supportive P-IIIb (STRENGTH) & P-I/II (STRONG) studies, where STEER showed a 2.39-point improvement in the…

ByRidhi RastogiJuly 2, 2026

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Junshi Biosciences Licenses Roconkibart to Fosun Wanbang in Greater China

Shots: Junshi Biosciences has entered into a license agreement with Fosun Wanbang Pharma Group for roconkibart in the Greater China region, incl. Mainland China, Hong Kong SAR, Macao SAR, & Taiwan Companies will cooperate on the development, registration, manufacturing & commercialization of roconkibart, an anti-IL-17A mAb, which showed 91% reached PASI 90 at wk. 16…

ByRidhi RastogiJuly 2, 2026

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Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Shots: Roche has reported the global P-III (Krascendo 1) trial assessing divarasib monotx. (QD) vs sotorasib (QD) or adagrasib (BID) in 338 pts with previously treated KRAS G12C-mutant advanced or metastatic NSCLC The trial met its 1 & key 2EPs, with divarasib achieving improvements in both PFS & OS; data to be submitted to health…

ByRidhi RastogiJuly 2, 2026

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Insilico Medicine Collaborates with Takeda to Advance AI Drug Discovery

Shots: Insilico Medicine has entered into a strategic collaboration agreement with Takeda to advance clinically differentiated drug candidates across Takeda's therapeutic areas, using Insilico’s Pharma.AI platform Insilico will lead AI-driven discovery, while Takeda will advance selected candidates through clinical development & hold exclusive worldwide rights to develop, manufacture, & commercialize resulting therapeutics As per the…

ByRidhi RastogiJuly 2, 2026

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Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US

Shots: Samsung Bioepis, in partnership with Harrow, has relaunched Byooviz, a biosimilar to Lucentis (ranibizumab), in the US Byooviz was initially commercialized by Biogen beginning in Jun 2022, before Biogen returned the US commercial rights to Samsung Bioepis at the end of 2025 Approved by the FDA in 2021 as the first ophthalmology biosimilar, Byooviz…

ByRidhi RastogiJuly 1, 2026

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RefleXion Seeks FDA Clearance for Anchor Point Tumor Tracking

Shots: The US FDA has received a 510(k) premarket notification for Anchor Point Tracking, a tumor tracking technology designed for use with its new RefleXion X2 radiotherapy platform Filing is backed by extensive system validation & phantom testing, with additional data from academic investigators demonstrating improved target tracking, dose conformity, motion management, & organ-at-risk sparing…

ByRidhi RastogiJuly 1, 2026

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BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

BeOne has reported topline P-III (MANGROVE) trial results on Brukinsa (Zanubrutinib; 160mg, PO, BID) + rituximab vs bendamustine + rituximab in 510 adults with previously untreated mantle cell lymphoma The trial met its 1EP of improved PFS as assessed by IRC, leading to a 43% reduction in the risk of progression or death; OS (2EP) was immature…

ByRidhi RastogiJuly 1, 2026

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Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

Shots: The US FDA has approved Tregzi (Orca-T) for use in a stem cell transplant to improve survival free of chronic graft versus host disease (GVHD) in adults with hematological malignancies Approval was backed by the P-III (Precision-T) trial assessing Orca-T + TAC vs conventional alloHSCT in pts (n=187) with acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, &…

ByRidhi RastogiJuly 1, 2026

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Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

Shots: CE Mark was based on the P-III (PANOVA-3) trial assessing Optune Pax used concomitantly with gem/nab-pac (n=285), vs CT alone (n=286) in 571 adults with locally advanced pancreatic cancer, with launch expected in Germany in coming wks. Trial improved mOS to 16.2 vs 14.2mos. in ITT, with 1yr. survival of 68.1% vs 60.2%. In…

ByRidhi RastogiJuly 1, 2026

Ridhi Rastogi

HUTCHMED Reports NMPA Conditional Approval of Orpathys (Savolitinib) for Gastric Cancer Patients with MET Amplification

Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Junshi Biosciences Licenses Roconkibart to Fosun Wanbang in Greater China

Roche Reports P-III (Krascendo 1) Trial Results on Divarasib for KRAS G12C-Mutant NSCLC

Insilico Medicine Collaborates with Takeda to Advance AI Drug Discovery

Samsung Bioepis and Harrow Relaunch Byooviz (Biosimilar, Lucentis) in the US

RefleXion Seeks FDA Clearance for Anchor Point Tumor Tracking

BeOne Medicines Reports P-III (MANGROVE) Trial Results for Brukinsa + Rituximab in 1L Mantle Cell Lymphoma

Orca Bio’s Tregzi Wins FDA Approval for Allogeneic Transplant in Adults with Hematological Malignancies

Novocure Receives the CE Mark for Optune Pax with CT for Pancreatic Cancer

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