BeiGene Ltd.

BeiGene's TEVIMBRA approved by European Commission for first-line treatment of advanced esophageal squamous cell carcinoma (ESCC) and gastric/gastroesophageal junction cancer with chemotherapy, based on Phase 3 studies showing significant survival benefits: 17.2 months vs 10.6 months for ESCC and 15.0 months vs 12.9 months for G/GEJ cancer.

In today’s episode of OncLive On Air, supported by BeiGene, Alexey Danilov, MD, PhD, and Nicole Lamanna, MD, discuss the use of zanubrutinib (Brukinsa) in chronic lymphocytic leukemia (CLL), focusing on efficacy data from the phase 3 ALPINE trial, associated toxicities, and the future of BTK inhibitor therapy in CLL.

The National Reimbursement Drug List (NRDL) faces budget pressure and competition, with 445 drugs passing formal review in 2024. Oncology, immunology, neurology, and rare diseases see strategic positioning and comparator choices as key. Contract renewals and re-negotiations are under pressure, emphasizing clear messaging and data preparation for NRDL success.

Zymeworks and Jazz Pharmaceuticals receive FDA accelerated approval for Ziihera (zanidatamab-hrii) in treating HER2-positive biliary tract cancer (BTC). Ziihera, a dual HER2-targeted bispecific antibody, is the first chemotherapy-free treatment for BTC. Zymeworks earns $25m milestone payment and is eligible for up to $1.3625b in milestones and royalties. FDA approval supported by HERIZON-BTC-01 trial data, showing 52% objective response rate and 14.9 months median duration of response.

The 'Lupus Nephritis - Pipeline Insight, 2024' report by ResearchAndMarkets.com provides a comprehensive overview of the current and future prospects of Lupus Nephritis treatments. It details the pipeline landscape, including disease overview, treatment guidelines, and assessments of emerging drugs like QLG1074, ADX-097, KYV-101, CABA-201, and NKX019. The report highlights ongoing R&D efforts, key collaborations, and trends in drug development, focusing on novel approaches to improve disease management. It also covers clinical trial stages, route of administration, and molecule types, identifying unmet needs and the impact of emerging therapies.

Zymeworks Inc.’s cancer drug zanidatamab (Ziihera) received FDA approval for treating biliary-tract cancer, marking a milestone in the company’s recovery. The drug is the first bispecific antibody and chemotherapy-free treatment for metastatic HER2-positive BTC. Zymeworks, which faced a corporate crisis in 2022, has partnered with Jazz Pharmaceuticals for North America, Europe, and Japan, and with BeiGene Ltd. for other Asian markets. The approval unlocks potential peak global sales of US$55-million, with further trials potentially expanding this to US$750-million. Zymeworks is eligible for up to US$500-million in milestone payments from Jazz and royalties of 10-20% on net sales.

Ziihera, a dual HER2-targeted bispecific antibody, received accelerated FDA approval for HER2-positive BTC, based on a 52% objective response rate and 14.9-month median duration of response. Zymeworks earned a $25M milestone payment and is eligible for up to $500M in regulatory milestones. Zanidatamab is also under regulatory review in China and Europe, and is being investigated in Phase 3 trials for gastroesophageal adenocarcinomas and metastatic breast cancer.

Halozyme offers to buy Evotec for €2B; Bluebird records first revenue from Lyfgenia; BeiGene rebrands as BeOne Medicines; Adaptimmune to lay off 33% of staff; Leerink Partners adds senior M&A directors; Abeona awaits FDA decision on pz-cel.

Cabaletta Bio reports Q3 2024 financial results, with $183M in cash, cash equivalents, and short-term investments, supporting operations into H1 2026. Clinical data from RESET-Myositis™, RESET-SLE™, and initial RESET-SSc™ trials to be presented at ACR Convergence 2024. 16 patients enrolled, 10 dosed in the RESET™ program, with 40 U.S. clinical sites actively recruiting. Plans to meet with FDA in 2025 for potential registrational program designs for CABA-201. Clinical development expands into Europe with EMA CTA authorization for CABA-201 in lupus; Gerwin Winter appointed as Senior VP and Head of International.

Cabaletta Bio reported Q3 2024 financial results and business updates, with 40 U.S. clinical sites actively recruiting patients across its RESET clinical trials, 16 enrolled and 10 dosed as of November 12. Clinical data from RESET-Myositis, RESET-SLE, and initial data from RESET-SSc trials will be presented at ACR Convergence 2024. The company received EMA CTA authorization for CABA-201 in lupus, expanding into Europe. Cash position stands at $183.0 million as of September 30, 2024, expected to fund operations into first half of 2026.