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Bioeq AG (Bioeq), a Swiss biopharmaceutical company, and Zydus Lifesciences (Zydus), an innovation-led life-sciences company with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Bioeq, for the licensing, supply and commercialization of Bioeqs Vascular Endothelial Growth Factor (VEGF) inhibitor NUFYMCO®, an interchangeable biosimilar of Lucentis® (Ranibizumab) for the U.S. market. The Biologics License Application (BLA) for NUFYMCO® has been approved by U.S. Food and Drug Administration (USFDA) on December 18, 2025. This transaction marks an expansion of Zydus' U.S. biosimilar business, following its recent partnership with Formycon AG for a biosimilar of Keytruda® (Pembrolizumab).
Under the terms of this agreement, Bioeq will be responsible for the development, manufacturing, registration and supply of the finished product, while Zydus will be responsible for the commercialisation of NUFYMCO® in the U.S. market.
Zydus Lifesciences has signed an agreement with Myriad Genetics, a leader in molecular diagnostic testing and precision medicine company. Pursuant to the Agreement, Zydus will be introducing MyRisk® Hereditary Cancer Test, MyChoice® HRD Plus, Homologous Recombination Deficiency (HRD) Test and Prolaris® Prostate Cancer Prognostic Test to patients, clinicians, and healthcare systems across India.
With the increasing incidence of cancers globally, the MyRisk® Test can help people safeguard their health and take precautionary steps and lifestyle changes that can minimise the risk of cancer. In patients suffering from prostate and ovarian cancers, the Prolaris® Test and MyChoice® HRD Plus Test, respectively, can help patients understand the disease progression and inform the right treatment path.
As part of this agreement, Zydus will exclusively market, create awareness, access and engage clinicians on three of Myriad Genetics' broadly validated diagnostic platforms, MyRisk® Hereditary Cancer Test, MyChoice® HRD Plus Test for ovarian cancer, and Prolaris® a gene expression Prostate Cancer Prognostic Test.
These tests have been widely adopted in the North America, Europe, and major global cancer centres, and will now empower Indian oncologists with cutting-edge genomic decision-support tools.
Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences (Zydus Group), today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for copper histidinate (CUTX-101), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class I response and as a result, the Company has received January 14, 2026 as the new PDUFA date.
“We appreciate the Agency's partnership and commitment to expeditiously reviewing our NDA resubmission,” said Matt Heck, CEO, Sentynl. “The acceptance of the application brings us one step closer to a milestone for patients and families who are living with Menkes disease.'
Sentynl resubmitted its revised NDA on 14 November 2025 after receiving a complete response letter (CRL) from the FDA on 30 September 2025, which cited observations regarding the manufacturing site's cGMP compliance. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101's efficacy and safety data, which demonstrate improvement in overall survival for Menkes disease subjects who received early treatment with the therapy.
Zydus Lifesciences has launched ‘Zyrifa', a Denosumab biosimilar. Denosumab is a monoclonal antibody with several indications related to bone health, primarily in the treatment of osteoporosis and the prevention of skeletal complications in cancer patients. This will provide access and treat patients with bone metastases due to breast, prostate, lung, myeloma, kidney, thyroid, head & neck, and other solid tumours. Metastases, is when the cancer spreads to the bones and other organs in the body indicating an advanced stage of cancer. ‘Zyrifa' is priced at MRP of Rs 12,495.
Speaking on this launch, Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences, said “With Denosumab 120 mg SC, we aim to bring access, affordability of medication in cancer patients needing critical care. This will help patients to retain mobility, and support them in their fight against cancer”
Zydus Lifesciences Limited has been launching a wide range of biosimilars to treat various cancers ranging from breast cancer to prostate cancer, various other solid tumours and blood cancer. The company has also partnered with diagnostic companies.
Bone metastases are a serious complication across multiple cancers, significantly affecting patient quality of life. Patients may experience pain, fractures, spinal cord compression, reduced mobility and loss of independence, often diminishing dignity and increasing mortality risk. The condition most commonly affects the axial skeleton—the spine, pelvis and ribs—leading to severe complications.
Population-scale studies indicate that bone involvement affects 50–70% of patients with advanced breast or prostate cancer, while 15–40% of those with lung, kidney, thyroid and melanoma also develop skeletal metastases over time.
Zydus Lifesciences has been launching a wide range of biosimilars to treat various cancers ranging from breast cancer to prostate cancer, various other solid tumours and blood cancer. The company has also partnered with diagnostic companies.
Dr Sharvil P. Patel, Managing Director, Zydus Lifesciences, said, “With Denosumab 120 mg SC, we aim to bring access, affordability of medication in cancer patients needing critical care. This will help patients to retain mobility and support them in their fight against cancer.”
The Zydus Group, with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives.
Zydus Lifesciences reported a 38.12% jump in consolidated net profit to Rs 1,258.60 crore in Q2 FY26, compared with Rs 911.2 crore posted in Q2 FY25. Revenue from operations increased 18.07% year on year (YoY) to Rs 6,037.9 crore in Q2 FY26.
The approved ANDA is a generic version of the US reference listed drug Glyxambi Tablets.
Empagliflozin and Linagliptin Tablets, in a combination, are indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and linagliptin is appropriate.
Empagliflozin and Linagliptin Tablets will be produced at the group’s formulation manufacturing facility at SEZ, Ahmedabad.
Empagliflozin and Linagliptin Tablets had annual sales of USD 215.8 mn in the United States (IQVIA MAT Sept-2025).
The group now has 428 approvals and has so far filed 487 ANDAs since the commencement of the filing process in FY 2003-04.
The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life-sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs over 27000 people worldwide and is driven by its mission to unlock new possibilities in lifesciences through quality healthcare solutions that impact lives.
The scrip rose 0.54% to currently trade at Rs 942.35 on the BSE.
The listing of Excelsoft Technologies is scheduled for today. The issue was subscribed 43.19 times. The issue opened on 19 November 2025 and it closed on 21 November 2025. The price band of the IPO was fixed between Rs 114 and 120 per share.
NCC has received a letter of acceptance from Public Works (Health & Education) Department, Assam for expansion and modernization of Gauhati Medical College & Hospital, Guwahati, Assam. The said contract valued at Rs 2,062.71 crore.
Nelco has received additional authorization for Unified License (Virtual Network Operator) license from Department of Telecommunications, Ministry of Communications, Government of India. It will allow Nelco to sell VSAT services of other UL- GMPCS licensees.
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Verapamil Hydrochloride extended-release tablets USP, 120 mg, 180 mg and 240 mg.
Jayant Infratech has received letter of acceptance from Konkan Railway Corporation for an engineering, procurement, and construction (EPC) contract. The total value of the contract is Rs 161,68,31,043.98 (inclusive of all duties and taxes).
Refex Industries has incorporated a wholly owned subsidiary, Venwind Refex Projects (VRPL) to engage in generating, transmitting, distributing, and trading power from all energy sources and in developing and operating related facilities.
United Breweries announced the launch of beer, Heineken Silver in New Delhi. The beer is now available in New Delhi and priced at Rs 155 for a 330ml bottle, Rs 180 for a 500ml can, and Rs 305 for a 650ml bottle.
Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA submission and commercialization of the product in the US.
The product, developed under the 505(b)(2) pathway, is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals.
The novel product targets a significant commercial opportunity in the US market, with an estimated total addressable market (TAM) of 6.2 million units, according to IQVIA MAT September 2025 data.
Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, said, “We are delighted to collaborate with RK Pharma to bring this innovative product to patients in the US. This partnership reinforces our commitment to delivering high-quality, affordable medicines and improving patient care.”
Dr. Ravishanker Kovi, Founder and Executive Chairman of RK Pharma, stated, “This novel 505(b)(2) product of supportive oncology treatment highlights RK Pharma’s testament to advanced capabilities in formulation and manufacturing, particularly in specialized areas like sterile injectables and complex generics. Our collaboration with Zydus, a company with robust regulatory expertise and a powerful commercial footprint, ensures that this important therapeutic option reaches patients efficiently, reinforcing our shared mission to improve access to high-quality healthcare in the USA.”