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Ichnos Glenmark Innovation (IGI), Glenmark's wholly owned subsidiary, has received an upfront payment of $700 million from AbbVie (NYSE: ABBV).
The payment is in accordance with the agreed contractual terms and is being made towards an exclusive global licensing agreement for IGI's lead investigational asset, ISB 2001 across North America, Europe, Japan, and Greater China markets.
Glenmark Pharmaceuticals announced the initiation of a multi-country (ex-China) Phase 3 Clinical Trial for Envafolimab, a novel subcutaneous PD-L1 inhibitor, in patients with resectable Stage III Non-Small Cell Lung Cancer (NSCLC) in the neoadjuvant/adjuvant setting. The Company has received approval from the Drugs Controller General of India (DCGI) to begin patient enrollment and dosing in the country.
In parallel, Glenmark has submitted a Clinical Trial Application (CTA) in Russia and is preparing to open additional clinical trial sites in Brazil and Mexico, further expanding the global footprint of this pivotal study.
The randomized, multi-center, Phase 3 trial will assess the efficacy, safety, pharmacokinetics, and immunogenicity of Envafolimab in patients with resectable Stage IIIA and IIIB (N2) NSCLC, while a parallel Phase 3 study of Envafolimab sponsored by 3D Medicines Inc., was initiated in December 2023 and is actively recruiting in China.
The product is the therapeutic equivalent of Halaven Injection (1 mg/2 mL), originally developed by Eisai, Inc. Glenmark’s version has been deemed bioequivalent and therapeutically equivalent by the U.S. Food and Drug Administration (USFDA), paving the way for its entry into the oncology segment of the U.S. injectable market.
According to IQVIA sales data for the 12-month period ending July 2025, Halaven Injection recorded annual sales of approximately $66.3 million in the United States.
Commenting on the launch, Marc Kikuchi, president & business head, North America said, “We are pleased to announce the launch of Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials. As the first complex generic in our portfolio, this launch marks both our commitment to growing our portfolio of products within the institutional channel and reinforces our dedication to bring quality and affordable alternatives to market for patients in need.”
Glenmark Pharmaceuticals is a research-led, global pharmaceutical company, having a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology.
The company's consolidated net profit jumped 49.9% to Rs 215.48 crore on 7.4% rise in revenue from operations to Rs 1505.62 crore in Q1 FY26 over Q1 FY25.
The scrip rose 0.53% to Rs 1,938.40 on the BSE.
Glenmark Pharmaceuticals Inc., USA (Glenmark) announced the upcoming launch of Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials.
Glenmark's Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-Dose Vials is bioequivalent and therapeutically equivalent to the reference listed drug, Halaven® Injection, 1 mg/2 mL (0.5 mg/mL), of Eisai, Inc., and the company will begin distribution in September 2025.
According to IQVIA® sales data for the 12-month period ending July 2025, the Halaven® Injection, 1 mg/2 mL (0.5 mg/mL) market achieved annual sales of approximately $66.3 million.