NSEPress Release2 Jul 2026 · 2 Jul 2026, 08:35 am
Press Release
Glenmark Pharmaceuticals Limited · GLENMARK
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Glenmark Pharmaceuticals Limited has informed the Exchange regarding a press release dated July 02, 2026, titled "Glenmark Advances Multi-Country Phase 3 Clinical Trial of Trastuzumab rezetecan in Platinum-Resistant Ovarian Cancer". The company announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan, a HER2-targeted antibody drug conjugate, for patients with platinum-resistant ovarian cancer.
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Glenmark Pharmaceuticals Limited has informed the Exchange regarding a press release dated July 02, 2026, titled "Glenmark Advances Multi-Country Phase 3 Clinical Trial of Trastuzumab rezetecan in Platinum-Resistant Ovarian Cancer".
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July 2, 2026
To, To,
National Stock Exchange of India Limited, BSE Limited,
“Exchange Plaza”, Corporate Relationship Department,
5th Floor, Plot No. C/1, G Block, 2nd Floor, New Trading Ring,
Bandra- Kurla Complex Bandra (East), P.J. Towers, Dalal Street,
Mumbai – 400 051 Mumbai – 400 001
NSE Symbol: GLENMARK BSE Scrip Code: 532296
ISIN: INE935A01035 ISIN: INE935A01035
Our Reference No. 27/26-27 Our Reference No. 27/26-27
Dear Sir/ Madam,
Sub: Glenmark Advances Multi-Country Phase 3 Clinical Trial of Trastuzumab rezetecan in Platinum-
Resistant Ovarian Cancer
Glenmark Specialty S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. (Glenmark)
announced the advancement of its multi-country Phase 3 clinical trial for Trastuzumab rezetecan
(SHR-A1811), a HER2-targeted antibody drug conjugate (ADC), for patients with platinum-resistant
ovarian cancer (PROC).
India will serve as the first country in Glenmark’s licensed markets to initiate patient enrollment for the
Phase 3 clinical trial, following the approval of Drugs Controller General of India (DCGI). Glenmark also
plans to enroll patients in Australia and South Korea, subject to regulatory approvals.
Kindly find attached media release which is self- explanatory.
Request you to kindly take the same on record.
Thanking You.
Yours faithfully,
For Glenmark Pharmaceuticals Limited
Rashmi Khandelwal
Company Secretary & Compliance Officer
ACS - 28839
Glenmark Pharmaceuticals Limited
Glenmark House, B. D. Sawant Marg, Andheri (East), Mumbai 400 099, India
T: +91 22 4018 9999 F: +91 22 4018 9986 CIN No: L24299MH1977PLC019982 W: www.glenmarkpharma.com
Registered office: B/2, Mahalaxmi Chambers, 22 Bhulabhai Desai Road, Mumbai 400 026 E: complianceofficer@glenmarkpharma.com
Glenmark Advances Multi-Country Phase 3 Clinical Trial of
Trastuzumab rezetecan in Platinum-Resistant Ovarian Cancer
Study aligned with Hengrui Pharma’s ongoing parent Phase 3 trial in China
India becomes the first country in Glenmark’s licensed markets to receive regulatory
approval for Phase 3 clinical trial extension
Additional patient enrollment planned in Australia and South Korea, subject to regulatory
approval
Mumbai, India, 02 July, 2026 – Glenmark Specialty S.A, a wholly owned subsidiary of
Glenmark Pharmaceuticals Ltd. (Glenmark) announced the advancement of its multi-country
Phase 3 clinical trial for Trastuzumab rezetecan (SHR-A1811), a HER2-targeted antibody drug
conjugate (ADC), for patients with platinum-resistant ovarian cancer (PROC).
India will serve as the first country in Glenmark’s licensed markets to initiate patient enrollment
for the Phase 3 clinical trial, following the approval of Drugs Controller General of India (DCGI).
Glenmark also plans to enroll patients in Australia and South Korea, subject to regulatory
approvals.
The study is aligned with Jiangsu Hengrui Pharmaceuticals Co. Ltd.’s ongoing parent Phase
3 trial in China. Glenmark aims to generate clinically relevant data across broader and more
diverse patient populations, supporting the development of Trastuzumab rezetecan across
Glenmark’s licensed markets. The randomized, controlled, multi-centre, Phase 3 trial is
designed to evaluate the efficacy, safety, and pharmacokinetics of Trastuzumab rezetecan in
patients with HER2-expressing platinum-resistant ovarian cancer, a difficult-to-treat disease
where treatment options remain limited, and outcomes continue to be poor. Conducting the
trial across multiple geographies is expected to support the generation of evidence from
diverse patient groups and strengthen the clinical data package for the therapy across
Glenmark’s licensed markets.
Commenting on the announcement, Dr. Monika Tandon, Global Head of Clinical
Development, Glenmark Pharmaceuticals Limited, said, “Advancing this pivotal Phase 3
trial marks an important step in Glenmark’s journey to build a differentiated oncology pipeline
for global markets. Platinum-resistant ovarian cancer remains an area of significant unmet
need, and the initiation of patient enrollment in India, with additional countries planned, reflects
our commitment to developing novel targeted therapies for patients with hard-to-treat cancers
and limited treatment options. This study also strengthens our ability to generate clinically
relevant evidence across diverse populations.”
Ovarian cancer remains one of the most challenging gynecologic malignancies globally. It is
the eighth1 most common cancer among women worldwide. India carries a significant burden,
ranking among the countries with the highest number of ovarian cancer cases and deaths
globally. Many patients with advanced ovarian cancer treated with available platinum-based
therapies develop recurrence and subsequently platinum resistance. This underscores the
need for continued clinical development of targeted therapies that may improve treatment
options for patients with advanced and resistant disease.
In September 2025, Glenmark entered into an exclusive collaboration and license agreement
with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (“Hengrui Pharma”) for Trastuzumab
rezetecan (SHR-A1811), securing rights to develop and commercialize the asset across
multiple markets. Under the agreement, Glenmark holds exclusive rights worldwide excluding
Mainland China, the Hong Kong SAR, the Macao SAR, Taiwan Region, USA, Canada,
Europe, Japan, Russia, Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova,
Tajikistan, Turkmenistan and Uzbekistan.
1PubMed
About Trastuzumab Rezetecan
Trastuzumab rezetecan (SHR-A1811) is a HER2-targeted first-in-class antibody-drug conjugate (ADC) developed
by Hengrui Pharma to address the challenges posed by HER2-overexpressing tumors, which are prevalent in
various cancer types, including breast, gastric and colorectal cancers.
In May 2025, it has been conditionally approved in China and is now marketed for the treatment of adult patients
with unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have HER2 (ERBB2)
activating mutations and have received at least one prior systemic therapy. This marked the first China-developed
ADC approved for HER2-mutated NSCLC.
Subsequently, in September 2025, the marketing authorization application for a new breast cancer indication was
accepted for review by China's National Medical Products Administration (NMPA) and granted Priority Review
designation. The application was approved in March 2026 for the treatment of patients with HER2-positive second-
line (2L) breast cancer.
In February 2026, Hengrui Pharma also filed a biologics license application (BLA) for the treatment of HER2-
positive advanced colorectal cancer.
To date, Trastuzumab rezetecan has been included in the NMPA’s Breakthrough Therapy Designation list for nine
indications, covering NSCLC, breast cancer, gastric or gastroesophageal junction adenocarcinoma, colorectal
cancer, biliary tract cancer, and gynecologic malignancies.
About Glenmark Pharmaceuticals Ltd.
Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is a global, research‐led pharmaceutical
company with a unique focus on innovation and accessibility. We pioneer transformative breakthrough therapies
that aim to redefine treatment while expanding access to high-quality and affordable medicines for patients around
the world. With 11 world-class manufacturing facilities across four continents, supported by six cutting-edge R&D
centres, and a commercial footprint in 80+ countries, we deliver a diversified portfolio across branded, innovative,
generics, and consumer health products, with a focus on respiratory, dermatology, and oncology. Scrip 100
positions Glenmark among the Top 100 biopharmaceutical companies globally by pharmaceutical sales for 2024.
For more information, visit www.glenmarkpharma.com.
For more information, please contact:
Akhila Natarajan | mediarelations@glenmarkpharma.com | +91 22 4018 9999
Adfactors PR | Jigyasha Sharma | glenmark.ihcp@adfactorspr.com | + 91 98
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