Glenmark’s 2025 oncology push: $1.1B ADC deal, Phase 3

What Glenmark announced in September 2025

Glenmark Pharmaceuticals has stepped up its oncology strategy on two fronts during September 2025: a major in-licensing deal for a HER2-targeted antibody-drug conjugate (ADC) and the start of a multi-country Phase 3 trial for a separate lung cancer therapy. The company announced an exclusive license and collaboration agreement with China’s Jiangsu Hengrui Pharmaceuticals for Trastuzumab Rezetecan (SHR-A1811). Separately, Glenmark initiated a randomised, multi-country Phase 3 clinical trial for Envafolimab in resectable stage III non-small cell lung cancer (NSCLC).

The twin announcements matter because they strengthen Glenmark’s higher-margin oncology portfolio, which management expects to support profitability as products move toward commercialisation. Glenmark has guided for an EBITDA margin of 23% for the ongoing fiscal and has indicated that oncology assets are expected to lift margins over time as new launches begin.

Trastuzumab Rezetecan: what the therapy targets

Trastuzumab Rezetecan (SHR-A1811) is described as a next-generation HER2-targeting ADC. In China, the drug is approved for HER2-positive cancers such as NSCLC, and it is also being explored for breast cancer. Glenmark said the product is advancing through multiple clinical trials.

The product also has regulatory developments outside China referenced in the disclosures around the deal. In August 2025, Trastuzumab Rezetecan, in combination with adebrelimab and chemotherapy, received Orphan Drug Designation from the US FDA for gastric or gastroesophageal junction adenocarcinoma.

Deal economics: upfront payment and milestones

The agreement is a $1.0 billion-plus licensing arrangement, with one disclosure describing it as a $1.1 billion deal. Under the stated terms, Glenmark will pay Hengrui an upfront fee of $18 million. Hengrui is eligible to receive up to $1,093 million in regulatory and commercial milestone payments, in addition to sales-based royalties from the licensed markets.

Glenmark entered the agreement through its wholly owned subsidiary Glenmark Specialty S.A. (GSSA). The structure indicates a typical in-licensing model where Glenmark funds development and commercialisation in specified territories and pays milestones and royalties linked to success.

Where Glenmark can sell the drug, and what is excluded

The licensing terms described in the provided information indicate Glenmark obtained exclusive rights for select markets, including India, and largely across emerging markets. The same deal description notes that Hengrui retains rights in developed markets including North America, Europe, Japan, China, Hong Kong, Taiwan, and Russia/CIS countries.

A separate description of the exclusions lists the United States, Europe, Japan, Canada, and certain Asian regions including Mainland China, Hong Kong, Macau, and Taiwan as excluded territories. Another mention also states the emerging-market rights exclude China, the US, Canada, Europe, Japan, Russia, and the Commonwealth of Independent States (CIS) region. The consistent takeaway across these descriptions is that Glenmark’s commercial footprint is focused on India and selected emerging markets, while Hengrui keeps key developed markets and Greater China.

Clinical trial data cited for Trastuzumab Rezetecan

The efficacy metrics highlighted in the available material position Trastuzumab Rezetecan as a high-response therapy in HER2-positive cancers, based on clinical trial results referenced by analysts. In NSCLC, the objective response rate (ORR) was stated at 74.5%, compared with a typical second-line treatment ORR of 30% and Enhertu’s 57.7% for the same indication. Median progression-free survival (PFS) was reported at 11.5 months, described as almost double standard second-line therapies.

In breast cancer trials, the ORR was stated to have exceeded 70%. That is compared in the same material with Enhertu’s 82.7% and Kadcyla’s 43.6%. The disclosures also note that China’s regulator accepted the drug for breast cancer in September 2025 with priority review status and granted breakthrough therapy designation for nine cancer indications, including NSCLC, breast, gastric, colorectal, biliary tract, and gynecologic cancers.

Envafolimab Phase 3 trial: countries, approvals, and next steps

Alongside the ADC deal, Glenmark initiated a randomised, multi-country Phase 3 clinical trial for Envafolimab, described as a novel drug for stage III NSCLC. The company received approval from the Drugs Controller General of India (DCGI) to begin patient enrolment and dosing in India.

The company also submitted a clinical trial application in Russia and said it is preparing to open additional clinical trial sites in Brazil and Mexico. This sequence indicates Glenmark is building a broader, multi-geography dataset for the Phase 3 programme, with India positioned to begin enrolment and dosing following regulatory clearance.

Profitability outlook and FY28 commercialisation timeline

Glenmark expects its higher-margin oncology assets to improve profitability as products move closer to launch. The company has guided for an EBITDA margin of 23% for the ongoing fiscal. It has also indicated that new products, including aumolertinib and Trastuzumab Rezetecan, are expected to begin commercialisation by FY28.

Separately, Glenmark has described Trastuzumab Rezetecan as a $1 billion buyout cancer drug in the context of its licensing strategy. The stated aim is for the product to enter in-licensed markets by FY28 and support an improvement in gross and EBITDA margins.

Market view: Nomura’s rating and target price

Nomura maintained a neutral rating on Glenmark Pharma and cited a target price of ₹1,500 following the announcement of the in-licensing agreement with Hengrui Pharma for Trastuzumab Rezetecan. The analyst note referenced Glenmark’s strategy of expanding its innovative cancer portfolio through strategic partnerships, using in-licensing to add advanced assets to its pipeline.

Key facts at a glance

Why these two moves matter for Glenmark’s oncology strategy

The Hengrui partnership adds a late-stage, clinically validated HER2 ADC to Glenmark’s portfolio, with market access aimed largely at India and select emerging markets. The Envafolimab Phase 3 start adds depth on the clinical development side, with DCGI approval enabling active enrolment and dosing in India and additional sites planned across multiple geographies.

Taken together, the moves align with Glenmark’s stated goal of improving margins through higher-value oncology products as commercialisation approaches. The FY28 timeline provided for launches such as Trastuzumab Rezetecan gives investors a concrete window referenced by the company, while the deal’s milestone and royalty structure clarifies the scale of potential payments linked to regulatory and commercial success.

What to watch next

The next near-term milestones are operational: patient enrolment and dosing progress in India for Envafolimab, and the opening of additional trial sites in Brazil and Mexico as planned. On the Trastuzumab Rezetecan front, investors will watch for further clinical trial updates and any regulatory progress in the in-licensed markets that Glenmark controls.

For Glenmark’s financial trajectory, the company’s stated expectation remains that oncology launches beginning by FY28 could support improvements in gross margin and EBITDA margin, building on the current EBITDA margin guidance of 23%.