Glenmark signs significant license agreement for a critical drug; complete details inside

In a strategic move to enhance its oncology portfolio, Glenmark Specialty S.A. (GSSA), a subsidiary of Glenmark Pharmaceuticals Ltd., has inked a significant license agreement with Jiangsu Alphamab Biopharmaceuticals Company Limited and 3D Medicines (Beijing) Company Limited (3DMed). This agreement grants GSSA an exclusive license for the development, registration, and commercialization of Envafolimab, branded as Enweida, across India, Asia Pacific, the Middle East and Africa, Russia, CIS, and Latin America.

About the drug

Envafolimab, a subcutaneous injection PD-L1 inhibitor, gained approval in China in November 2021 as a groundbreaking treatment for adult patients with previously treated microsatellite instability-high (MSI-H) or deficient MisMatch repair (dMMR) advanced solid tumours. The National Medical Products Administration (Chinese NMPA) officially included Envafolimab in the “List of Breakthrough Therapies” in December 2023, attesting to its significant impact on patient outcomes.

Under the terms of the agreement, Jiangsu Alphamab will exclusively supply Envafolimab to GSSA, receiving a low double-digit Million US Dollar amount up to launch. Furthermore, additional triple-digit Million US Dollar milestone payments based on sales performance and a royalty fee of single-to-double digits percentage according to net sales will be paid to Jiangsu Alphamab over the agreement’s duration.

The prevalence of dMMR across 13 tumour types, estimated at 16%, underscores the potential of Envafolimab to address a widespread genetic signature among cancer patients. With over 30,000 patients benefiting from Envafolimab in China, its expansion into Emerging Markets holds promise for providing an effective treatment option for this patient population.

Gaining traction globally

Envafolimab is not only making waves in Asia but also gaining traction in the USA, where Tracon Pharma is conducting a pivotal trial in soft tissue sarcoma (STS) subtypes, including Undifferentiated Pleomorphic Sarcoma (UPS) and genetically related myxofibrosarcoma (MFS). The U.S. FDA has granted two orphan drug designations for advanced biliary tract cancer and STS, along with a Fast Track designation for STS. Ongoing developments include additional indications such as Biliary Tract cancer and non-small cell lung cancer.

The collaboration between GSSA, Jiangsu Alphamab, and 3DMed signifies a strategic alignment to bring cutting-edge oncology treatments to patients in key regions. Envafolimab’s success in China and its ongoing clinical trials in the USA highlight its potential to reshape the landscape of cancer treatment, offering hope to patients across diverse geographical and genetic contexts. As the global oncology market continues to evolve, this collaboration positions Glenmark Specialty as a key player in advancing innovative therapies and addressing unmet medical needs in the fight against cancer.

Stock Performance 

At the start of the day, the company’s stock began trading at Rs 890.85, almost flat compared to the previous day’s closing price on the BSE. As of writing this article, it is trading at Rs 906.80, representing a 1.8% increase. Additionally, the stock has delivered an impressive multibagger return of 127% in the past year to its shareholders. The current market capitalisation of the company stands at Rs 25,587 crore on the BSE.

Glenmark Pharmaceuticals Ltd is a global research-led pharmaceutical company with a presence across generics, specialty, and over-the-counter (OTC) businesses. The company operates in over 80 countries.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.