Envafolimab

Glenmark Pharma's US business launched Lacosamide, an anti-epileptic drug, with 201 authorized products and 51 ANDAs pending approval. The company expects Q3FY25 to improve with new product launches. North America revenue was Rs 740.5 crore in Q2FY25, contributing 21.6% to overall sales. Glenmark aims for Rs 13,500-14,000 crore revenue with 19% EBITDA margin in FY25. Shares are up 80% YTD with a market cap of Rs 43,600 crore.

Alphamab Oncology's JSKN033, a high-concentration subcutaneous co-formulation of anti-HER2 bispecific ADC and PD-L1 immune checkpoint inhibitor, has been included in the Shanghai Municipal Drug Administration's pilot program for optimizing clinical trial review and approval. This inclusion is expected to expedite the phase I/II clinical trial for advanced malignant tumors, offering a potentially safer and more effective treatment option.

Alphamab Oncology's JSKN033, a high-concentration subcutaneous co-formulation of anti-HER2 bispecific ADC and PD-L1 immune checkpoint inhibitor, has been included in the Shanghai Municipal Drug Administration's pilot program for optimizing clinical trial review and approval, expediting its phase I/II clinical trial for advanced malignant tumors. JSKN033, combining immunotherapy and ADC, aims to enhance efficacy and safety, with encouraging results from its Australian phase I/II study presented at SITC 2024.

38 uHCC patients received protocol-specified therapy; 52.6% discontinued due to disease progression. 17 patients suitable for surgery, 16 underwent surgery with 100% R0 resection. Median follow-up was 16.9 months; ORR was 50% per RECIST 1.1, and 83.3% per mRECIST. Median PFS was 7.58 months, and median OS was 19.9 months. 97.4% experienced at least one TRAE, with 52.6% experiencing grade ≥3 TRAEs. Combination therapy enhanced immune environment, with significant increases in immune cells and TLS in PR patients.

Alphamab Oncology's subsidiary, Jiangsu Alphamab, signed a licensing agreement with JMT-Bio for anti-HER2 bispecific ADC JSKN003, granting JMT-Bio exclusive rights in mainland China. Alphamab retains supply rights and is entitled to upfront and milestone payments totaling RMB 3.08 billion, plus royalties on net sales.