Zydus Lifesciences Ltd

Zydus Lifesciences announced that the pivotal Dahlia pharmacokinetic study (PK study) has successfully met its primary study objective. The randomized, double-blind, multi-centre clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 (pembrolizumab) with the oncology blockbuster drug Keytruda'. Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda' (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets. The positive clinical data for the FYB206 marks a key milestone in our collaboration with Formycon and reflects our shared commitment to expand access to affordable, life-saving oncology treatments. stated Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited. FYB206 represents the absolute cornerstone of our strategic entry into the complex North American immuno-oncology market. At the beginning of 2025, Formycon and the US Food and Drug Administration (FDA) had agreed on a streamlined clinical strategy that aims to sufficiently demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda', based on comprehensive analytical data and data from the Dahlia PK study. Having achieved the primary study objective, Formycon is now focusing on completing all development activities to finalize the documents for regulatory approval. The company is working closely with the regulatory authorities to make FYB206 available as soon as possible after the exclusivity of the reference drug expires. With the clinical data package effectively complete, this achievement clears the pathway for a near-term Biologics License Application (BLA) filing with the USFDA. This positions Zydus as a potential first wave filer and a new entrant in the North American immuno-oncology biosimilar market.Powered by Capital Market - Live

The inspection was carried out at the company's Unit 9 facility at Zydus Biotech Park in Changodar, Ahmedabad, from 16 February to 19 February, 2026, the drug maker said in a regulatory filing. The company added that the inspection concluded without any observations, indicating compliance with the regulator's standards. Zydus Lifesciences operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products. The company's consolidated net profit rose 7.7% to Rs 1,102.64 crore on 32.3% increase in revenue from operations to Rs 6,780.40 crore in Q3 FY26 over Q3 FY25. Shares of Zydus Lifesciences rose 0.08% to Rs 903 on the BSE. Powered by Capital Market - Live

The company has also entered into an agreement with Regeneron Pharmaceuticals, Inc. and Bayer. Anyra is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME), diabetic retinopathy (DR), and visual impairment due to myopic choroidal neovascularisation (mCNV). With this launch, Zydus reinforces its commitment to advancing ophthalmic care and expanding access to high-quality, affordable biologics for patients across India. Presently, more than 100 million people in India are living with diabetes, making it one of the largest diabetic populations globally. Diabetic Retinopathy (DR) affects an estimated 7'8 million individuals, with many progressing to vision-threatening stages such as DME. Wet AMD impacts approximately 1.5' 2 million elderly patients, while retinal vein occlusions affect over 2 million individuals. Collectively, these conditions represent a large patient pool requiring timely anti-VEGF therapy to prevent irreversible vision loss. As chronic retinal diseases require repeated intravitreal injections over extended periods, affordability and continuity of treatment are of concern. Enhanced access to such therapies improves treatment adherence, reduces preventable blindness, and lowers long-term disease burden. Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences, said, 'At Zydus, we are committed to making advanced biologics accessible to patients who need them most. ANYRA' is a transformative step for affordable retinal care in India. By delivering a high-quality, indigenously developed Aflibercept 2 mg, we are expanding patient access to critical therapies with advanced biologics. Our focus remains on enabling patient-centric outcomes by leveraging science, health and innovation.' Separately, the company received final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets for oral suspension, 32 mg (USRLD: Tracleer Tablets for Oral Suspension, 32 mg). The drug is indicated for the treatment of pulmonary arterial hypertension (PAH), specifically to improve exercise ability and reduce clinical worsening in children (aged 3 years and older) with idiopathic or congenital PAH. It is a dual endothelin receptor antagonist that lowers high blood pressure in the lungs, typically administered based on body weight. The product will be manufactured at the group's formulation facility at SEZ, Ahmedabad. According to IQVIA MAT December 2025 data, Bosentan 32 mg tablets recorded annual sales of $9.3 million in the United States. The group now holds 432 approvals and has filed 505 ANDAs since the commencement of its filing process in FY2003'04. Zydus Lifesciences operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products. The company's consolidated net profit rose 7.7% to Rs 1,102.64 crore on 32.3% increase in revenue from operations to Rs 6,780.40 crore in Q3 FY26 over Q3 FY25. Shares of Zydus Lifesciences rose 0.48% to Rs 914.45 on the BSE. Powered by Capital Market - Live

Zydus Lifesciences announced the launch of Anyra', India's first indigenously developed biosimilar of Aflibercept 2 mg. Zydus has also signed an agreement with Regeneron Pharmaceuticals, Inc. and Bayer. Anyra' is indicated for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD), visual impairment due to macular edema secondary to Retinal Vein Occlusion (Branch RVO or Central RVO), visual impairment due to Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and visual impairment due to Myopic Choroidal Neovascularization (mCNV). With this launch, Zydus reinforces its commitment to advancing ophthalmic care and expanding access to high-quality, affordable biologics for patients across India. Speaking on the launch, Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences, said, 'At Zydus, we are committed to making advanced biologics accessible to patients who need them most. ANYRA' is a transformative step for affordable retinal care in India. By delivering a high-quality, indigenously developed Aflibercept 2 mg, we are expanding patient access to critical therapies with advanced biologics. Our focus remains on enabling patient-centric outcomes by leveraging science, health and innovation.'Powered by Capital Market - Live

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets, oral suspension, 32 mg (USRLD: Tracleer' Tablets for Oral Suspension, 32 mg). Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension (PAH), specifically to improve exercise ability and reduce clinical worsening in children (aged 3 years and older) with idiopathic or congenital PAH. It is a dual endothelin receptor antagonist that lowers high blood pressure in the lungs, typically administered based on body weight. Bosentan 32 mg tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad. Bosentan 32 mg tablets had annual sales of USD 9.3 mn in the United States (IQVIA MAT December 2025). Powered by Capital Market - Live

The drug-free, handheld device features a patented 3-resistance system to aid mucus clearance and improve breathing in patients with COPD, asthma, and bronchiectasis. PEPAIR is being launched in partnership with AeroDel Technology Innovations, a domestic medical device firm specializing in inhalation and pulmonary rehabilitation solutions. The device addresses chronic mucous hypersecretion, which affects over 90 lakh patients in India, by promoting airway clearance, reducing cough, and supporting optimal respiratory therapy. Speaking on the launch, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, said, 'PEPAIR' introduces a patient-centric, drug-free solution to make airway clearance accessible and affordable for millions of patients with chronic respiratory conditions in India.' Respiratory diseases in India are rising due to air pollution, urbanization, climate-driven allergens, and delayed diagnosis of chronic lung conditions. OPEP therapy, recommended in clinical guidelines, has seen limited adoption due to cost constraints'an access gap PEPAIR' aims to fill. Zydus is a leading player in respiratory care in India, with a strong portfolio of oral bronchodilators and inhalation therapies, including Deriphyllin', Forglyn', Forglyn' Plus, Odihale'G, and Umiflo' Plus. The company continues to expand its innovation in ICS+LABA, LABA+LAMA, and single-inhaler triple therapies. Zydus Lifesciences operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products. The company's consolidated net profit rose 7.7% to Rs 1,102.64 crore on 32.3% increase in revenue from operations to Rs 6,780.40 crore in Q3 FY26 over Q3 FY25. Shares of Zydus Lifesciences shed 0.23% to Rs 907.90 on the BSE. Powered by Capital Market - Live

Zydus Lifesciences launched PEPAIR', India's first affordable Oscillating Positive Expiratory Pressure (OPEP) device featuring a 3-resistance system designed to help clear congestion and support effective mucous clearance and improve breathing in patients with COPD, Asthma, and Bronchiectasis. PEPAIR' is an innovative, drug-free, handheld device with patented design. More than 90 lakh patients suffer from these chronic respiratory conditions in India. Chronic mucous hypersecretion is a common problem amongst these patients that requires an airway clearance solution for everyday care. PEPAIR' is being launched in agreement with AeroDel Technology Innovations, an Indian medical device company focused on simplifying inhalation through drug-delivery, pulmonary rehabilitation. In a patient-centric approach, Zydus offers PEPAIR™'at an affordable cost of Rs. 990 per unit. Speaking on the launch, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, said, 'At Zydus, patient-centric innovation is about advancing healthcare in ways that make everyday care more accessible for patients. With PEPAIR', India's first affordable OPEP device, we are introducing a drug free, handheld solution designed to support better breathing for patients with COPD, asthma and bronchiectasis. We look forward to expanding our efforts in advancing respiratory health through this launch'Powered by Capital Market - Live

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Ammonium Lactate Cream, 12% (USRLD: Lac-Hydrin Cream', 12%). Ammonium lactate cream, 12% is a topical prescription medication indicated for the treatment of dry, scaly skin (xerosis) and an inherited dry skin condition called ichthyosis vulgaris. It is used to moisturise the skin by increasing hydration and, as an alpha-hydroxy acid, helps relieve itching, soften skin, and decrease skin scaling. Ammonium lactate cream will be manufactured at the group's topical manufacturing site at Changodar, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. Ammonium lactate cream had annual sales of USD 15 mn in the United States (IQVIA MAT December 2025). The group now has 430 approvals and has so far filed 505* ANDAs since the commencement of the filing process in FY 2003-04. Powered by Capital Market - Live

The company, along with its wholly owned subsidiary Zydus Pharmaceuticals USA, has entered into a settlement that concludes all ongoing patent litigations with Astellas concerning Myrbetriq and Mirabegron. Under the terms of the agreement, Zydus will pay Astellas an aggregate amount of $120 million. In addition, the company will pay a prepaid per-unit licensing fee on sales of its generic Mirabegron in the US from the date of the settlement until September 2027. Other terms of the agreement remain confidential. The settlement enables Zydus to continue marketing its generic Mirabegron product in the US market. In April 2025, Zydus had informed exchanges that the United States District Court for the District of Delaware had ruled in favour of Astellas on the validity of US Patent No. 10,842,780 related to a sustained-release formulation of mirabegron marketed as Myrbetriq. The court order had upheld the patent's validity, while issues relating to alleged infringement and damages were scheduled to be litigated at a consolidated jury trial in 2026. Zydus Lifesciences is a global life sciences company with operations across pharmaceuticals, consumer wellness, and medical technology. On a consolidated basis, its net profit rose 1.82% to Rs 1042.10 crore while net sales rose 32.34% to Rs 6780.40 crore in Q3 December 2025 over Q3 December 2024. Powered by Capital Market - Live

Zydus Lifesciences announced that the company and Zydus Pharmaceuticals USA, Inc., USA, a wholly owned subsidiary, (together referred to as Zydus), have entered into a Settlement Agreement with Astellas in relation to Astellas' Myrbetriq' (generic name: Mirabegron). Under the terms of the Settlement Agreement: 1. Zydus shall pay Astellas an aggregate amount of USD 120 million. 2. Zydus shall additionally pay a prepaid per unit licensing fee on units of Zydus' generic Mirabegron sold in the US from the date of Settlement Agreement till September 2027. This Settlement Agreement concludes all litigations between Astellas and the two companies relating to Myrbetriq' and Mirabegron and enables Zydus to continue marketing its generic Mirabegron in the US. Powered by Capital Market - Live