3D Medicines and Alphamab Oncology Secure $700.8M Deal with Glenmark for Subcutaneous PD-L1 Inhibitor Envafolimab in Emerging Markets

Today, 3D Medicines and Alphamab Oncology jointly announced that they have reached an agreement with Glenmark Pharmaceuticals, granting Glenmark exclusive licensing rights for the development and commercialization of the subcutaneous PD-L1 antibody drug Envafolimab Injection (brand name: ENVIDA®) for oncology indications in India, the Asia-Pacific region (excluding Singapore, Thailand, and Malaysia), the Middle East and Africa, Russia, the Commonwealth of Independent States (CIS), and Latin America. Glenmark Pharmaceuticals shall bear all costs associated with the development and commercialization of Envafolimab.

Under the license agreement, the Licensor will receive from Glenmark a total of US$700.8 million, comprising a non-refundable upfront payment and milestone payments based on the development and commercialization progress and sales performance of envafolimab, as well as tiered royalties in the single- to double-digit percentages of net sales of envafolimab.Each Licensor’s right to receive payments (including upfront payments, milestone payments, and royalties) under the License Agreement is subject to the agreement entered into between 3D Medicines and Alphamab Oncology. Alphamab Oncology retains the exclusive global right to manufacture envafolimab for any purpose. 3D Medicines retains the global development rights for any purpose in the oncology field, excluding the already licensed scope.

This collaboration effectively leverages Glenmark’s existing team and resources to rapidly establish a favorable market position for envafolimab in the aforementioned regions, while the implementation of the licensing agreement will have a positive impact on the commercialization of envafolimab in these areas.

In November 2021, envafolimab was officially approved for marketing in China. It is indicated for the treatment of adult patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) advanced solid tumors, including those with advanced colorectal cancer who have experienced disease progression after prior treatment with fluoropyrimidines, oxaliplatin, and irinotecan, as well as those with other advanced solid tumors who have experienced disease progression after prior therapy and have no satisfactory alternative treatment options.

Envafolimab has become the world’s first subcutaneously injected PD-L1 inhibitor. Alphamab Oncology, as the originator, is responsible for production and quality control; 3D Medicines is responsible for clinical development in oncology; and Simcere Pharmaceutical is responsible for the exclusive promotion of the product in mainland China.

This is the first anti-PD-L1 monoclonal antibody new drug developed and approved for marketing by a Chinese company. Unlike most products with the same target that are administered via intravenous injection, envafolimab is administered subcutaneously. The drug can be delivered within 30 seconds, significantly saving time for both doctors and patients as well as medical resources. Due to its unique design, envafolimab offers advantages in terms of efficacy, safety, convenience, and compliance. Patients do not require intravenous infusion, and it is expected to reduce healthcare costs.

Currently, envafolimab is conducting simultaneous clinical trials for multiple tumor indications in China, the United States, and Japan, with several indications having advanced to registration/Phase III clinical trials. Furthermore, it has been granted Orphan Drug Designation by the U.S. FDA for advanced biliary tract cancer and soft tissue sarcoma.

At the time of its market launch in 2021, the domestic PD-(L)1 market was already a red ocean, but envafolimab secured a niche by leveraging its prominent differentiated advantages.According to the performance data disclosed by 3D Medicines, the sales revenue of envafolimab reached RMB 567 million in 2022.

Glenmark, the counterparty in this transaction, is currently the fourth-largest pharmaceutical company in India.Founded in 1977, the company pioneered its entry into the pharmaceutical market with dermatological drugs. It boasts an independent R&D center and has established manufacturing facilities compliant with U.S. FDA regulations. Additionally, it has set up production plants in the United States and Switzerland for the development of injectables, oral formulations, and biologics, while engaging in the diversified production and operation of active pharmaceutical ingredients (APIs).

Currently, Glenmark’s business spans branded generics, generic drugs, and over-the-counter (OTC) medicines, with a strategic focus on the therapeutic areas of respiratory, dermatology, and oncology. The company operates 10 world-class manufacturing facilities across four continents and has a presence in more than 80 countries. With a market share valued at $3.6 billion, Glenmark ranks among the top 80 pharmaceutical companies globally, the top 8 in Asia, and is one of the fastest-growing pharmaceutical enterprises in India.

In recent years, Glenmark has focused on the research and development of new drugs and biosimilars in the fields of oncology, dermatology, and respiratory diseases.Among these, the company’s product aprepitant is the first NK-1 receptor antagonist, which binds with high selectivity to NK-1 receptors in the brain and antagonizes substance P. Aprepitant can effectively prevent vomiting, and its antiemetic regimen in combination with 5-HT3 receptor antagonists and glucocorticoids has been recommended by international authoritative guidelines.

Meanwhile, Glenmark has become the first company in India to launch a biosimilar of the popular anti-diabetic drug liraglutide. Approved by the Drug Controller General of India (DCGI), the drug is marketed under the brand name Lirafit™. Priced at approximately 100 Indian rupees for the standard daily dose of 1.2 mg, it reduces treatment costs by about 70%. The launch of Lirafit enables Glenmark to establish its presence in the injectable anti-diabetic drug market, marking another significant step forward in the field of diabetes treatment.

The introduction of envafolimab, jointly developed by 3D Medicines and Alphamab Oncology, represents Glenmark’s strategic deepening in the field of novel oncology drugs. Glenn Saldanha, Chairman and Managing Director of Glenmark, stated, “This collaboration marks a significant milestone for Glenmark. Through this transaction, we have secured regional promotion rights for the world’s first subcutaneously administered PD-L1 recombinant humanized single-domain antibody. We look forward to introducing this innovative product to make a positive contribution to the field of tumor immunotherapy and help cancer patients in emerging markets.”