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.

Commenting on the partnership, 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.

The novel 505(b)(2) product targets a significant commercial opportunity in the U.S. market, with an estimated total addressable market (TAM) of 6.2 million units, according to IQVIA data MAT September 2025.

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·         Aim to engage more than 7000 women in Bengaluru alone

·         From 3 km community runs to 100 km ultras, Pinkathon 2025–26 will begin its Bengaluru chapter on January 25 at Sree Kanteerava Stadium, Bengaluru

Bengaluru, November 18^th, 2025 : Zydus Lifesciences Ltd., a global innovation-led healthcare company, and Pinkathon, India’s biggest women’s run, today announced the 7^th edition of the Bengaluru Pinkathon scheduled for January 25^th, 2026, at the iconic Sree Kanteerava Stadium, Bengaluru as a part of their ongoing nationwide campaign to raise awareness on breast cancer and women’s health. The Bengaluru run aims to bring together 7000 women from all walks of life to spread the message of early detection and regular self-breast exams.

As part of its collaboration with Pinkathon, Zydus aims to reach women across six major cities in India, Mumbai, Bengaluru, Delhi, Hyderabad, Kolkata, and Chennai, through the 2025–26 Pinkathon season. The Bengaluru event reinforces Zydus’ continued commitment to empowering women to take charge of their health and well-being.

The official announcement was made by Dr. C. N. Patil, HOD and Lead Consultant – Medical Oncology & Haemato Oncology, Aster CMI, Bengaluru and Milind Soman, Founder of Pinkathon, along with Ankita Konwar, Founder of Invincible Women. The leaders reiterated their shared mission to drive awareness around the importance of preventive healthcare, especially in the fight against breast cancer.

Speaking on the campaign, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., said, “With the Easiest Exam campaign, we seek to empower women with the knowledge that a simple 3-minute self-examination each month can make a life-saving difference. Joining hands with Pinkathon, we aim to reach many more women, raise awareness, and inspire collective action in the fight against breast cancer. We believe that raising awareness on women’s health and Breast cancer remains equally vital, as early detection has the power to save countless lives.”

Unveiling the 7th Bengaluru Pinkathon at the city press conference, Milind Soman, Founder of Pinkathon, said, “Pinkathon has always been more than a run – it’s a movement that inspires women to prioritise their physical and emotional well-being. Every edition reminds us of the power of community when women come together for their health. With the support of Zydus this year, we are strengthening our mission of spreading awareness about breast cancer and ensuring that every woman understands the importance of early detection.” Over the next six months, Zydus Pinkathon will travel to Delhi, Hyderabad, Kolkata, and Chennai, engaging more than 30,000 women nationwide.

Ankita Konwar, Founder, Invincible Women, said, “For me, Pinkathon is a safe, joyful space where women of all ages, backgrounds, and abilities show up for themselves. Every woman who steps out to participate makes a statement — that her health matters. This collaboration with Zydus enables us to amplify conversations around self-examination and proactive health choices, and I’m excited to see Bengaluru turn up in full strength.”

Breast cancer continues to be one of the most prevalent forms of cancer affecting women worldwide, with rising cases in India. Over 2 lakh women are diagnosed with breast cancer each year, and tragically, every 8 minutes a woman loses her life due to late diagnosis. The Easiest Exam campaign by Zydus encourages women to take charge of their health through a simple 3-minute monthly self-breast examination.

Speaking on the occasion, Dr. C. N. Patil, HOD and Lead Consultant – Medical Oncology & Haemato-Oncology at Aster CMI Hospital, said: “Breast cancer remains one of the most common cancers among women, but early detection can significantly improve outcomes. Initiatives like Pinkathon are essential in encouraging women to take proactive steps such as a simple monthly 3-minute self-check that can prove life-saving.”

The second edition of the Easiest Exam campaign has been launched this October during Breast Cancer Awareness Month, focusing on the message, “Do haath, teen minute aur ek easy exam” a simple yet powerful habit that can help save lives. The initiative includes awareness drives, podcasts, stories of breast cancer warriors, and expert conversations with oncologists to break myths and stigma surrounding breast cancer.

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Bengaluru, 23 September 2025 : Zydus Lifesciences Ltd., a global innovation-led healthcare company, and Pinkathon, India’s biggest women’s run, today announced their nationwide collaboration to drive awareness on breast cancer and women’s health. The initiative is part of Zydus’ “Easiest Exam” campaign, now in its second edition, which emphasizes how a simple 3-minute self-breast exam every month can help save lives through early detection. As part of this effort, Zydus Pinkathon will travel across six major cities in 2025–26, engaging more than 30,000 women nationwide. The journey will begin with the 10th edition of the Mumbai Pinkathon on 21st December 2025 at MMRDA Grounds, BKC, followed by Bengaluru, Delhi, Hyderabad, Kolkata, and Chennai.

The official event was unveiled by Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., Meha Patel, Vice-Chairperson, Zydus Foundation, actor and renowned fitness icon Milind Soman, Founder of Pinkathon and Ankita Konwar, Founder of Invincible Women. They expressed their enthusiasm for the event, highlighting its mission to encourage women to prioritize their health. They particularly highlighted the importance of regular self-breast exam and Zydus Pinkathon’s vital role in raising awareness about early detection in breast cancer.

Speaking on the occasion, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, said, “With the Easiest Exam campaign, we seek to empower women with the knowledge that a simple 3-minute self-examination each month can make a life-saving difference. Joining hands with Pinkathon, we aim to reach many more women, raise awareness, and inspire collective action in the fight against breast cancer. We believe that raising awareness on women’s health and Breast cancer remains equally vital, as early detection has the power to save countless lives.”

Milind Soman, founder and the driving force behind Pinkathon, said, “At Pinkathon, our mission has always been to encourage every woman to take charge of her health and fitness, while building a community that celebrates strength and inclusivity. With Zydus coming on board as the Title Partner for Pinkathon we are taking this mission on a larger scale and urging women from all walks of life to participate and make health their priority. Together with Zydus, we are creating a powerful platform that will not only raise awareness but also drive meaningful action for women’s health across India.”

Ms Meha Patel, Vice Chairperson, Zydus Foundation said, “A woman is at the very core of the entire family’s happiness and wellbeing. Therefore, It is very important to spread the message that women need to prioritise their health. As it is rightly emphasised today, ‘Swasth Nari, Sashakt Parivaar’. The awareness on self-breast exam to help detect breast cancer early can be a life-saving step for millions of women as we need to arrest the alarming rise of breast cancer cases in India.”

The 2025–26 season of Zydus Pinkathon will offer race categories across fitness levels—3 km, 5 km, 10 km, and ultra-distances of 50 km, 75 km, 100 km, and the 100 km relay under the Invincible Women initiative.

The Easiest Exam Campaign

Breast cancer continues to be one of the most prevalent forms of cancer affecting women worldwide, and the rising cases in India is deeply concerning. In India, over 2 lakh women are diagnosed with breast cancer every year. Unfortunately, of these, every 8 minutes a woman dies because of last stage diagnosis. If detected early, it is treatable. Zydus’ campaign, The Easiest Exam, urges women to take a simple yet powerful step towards their health – a simple 3-minute self-breast exam that should be performed regularly.

The second edition of the Easiest Exam campaign is scheduled to launch in October, a month globally recognised as Breast Cancer Awareness Month. The second edition of the Easiest Exam emphasises on how ‘Do haath, teen minute aur ek easy exam’ can change a women’s life. The initiative will encompass awareness campaigns, podcasts, engagement with breast cancer warriors and on-ground events. Through thoughtful dialogues with some of India’s foremost oncologists the series will dispel prevailing myths and misconceptions associated with breast cancer. The objective is to address the stigma around breast cancer and dispel myths. The campaign will further highlight the journeys of breast cancer warriors—stories of strength, resilience, and hope.

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Bengaluru, India, 23^rd August, 2025 : Zydus Lifesciences Limited (including its subsidiaries/affiliates hereafter referred to as “Zydus”) an innovation-led global lifesciences company held a health symposium at Bengaluru to create a convergence of leading healthcare professionals who spoke on the transition to a new influenza vaccination guideline, as recommended by the World Health Organisation (WHO) for Northern hemisphere 2025-26.

Global influenza remains a significant public health concern, causing an estimated 400,000 respiratory and 300,000 deaths across the world annually¹. In US and Europe almost 50% of the population is vaccinated for seasonal flu annually¹. India which successfully leads the universal immunisation programme (UIP), has been able to counter several debilitating childhood vaccine preventable diseases. However, in India the flu vaccination is an unmet need and has less than 1.5 % of the population getting vaccinated.

Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited said, “Good health starts with prevention, and vaccines play a key role in protecting people and improving health. Influenza continues to pose a recurring challenge, leading to seasonal outbreaks and placing a considerable burden on healthcare systems. Vaccination plays a vital role in reducing the spread of infection, lowering the severity of disease, and preventing complications, especially among high-risk and vulnerable groups. At Zydus, we are committed to advancing preventive healthcare by promoting timely vaccination and raising awareness about its importance in controlling influenza and safeguarding public health.”

As per WHO’s 2025-26 recommendations of NH strains, the persistent absence of naturally occurring B/Yamagata lineage viruses since March 2020 indicates a very low risk of infection². Consequently, the inclusion of a B/Yamagata antigen in quadrivalent influenza vaccines is no longer considered necessary. Aligning with this, the CDC has excluded the B/Yamagata component from all U.S. influenza vaccines starting with the 2024–25 season³. This decision reflects global surveillance data and aims to streamline vaccine composition for improved efficacy and production efficiency.

National Centre for Disease Control (NCDC), India has also recommended to follow the WHO guidelines to adopt the latest strain of the vaccine, to prevent influenza and influenza-like illnesses which is emerging as a serious health concern⁴. The disease disproportionately affects vulnerable populations such as infants, the elderly, and individuals with chronic conditions.

Seasonal influenza infections happen in India throughout the year, with twin peaks during the monsoon and winter seasons⁵. Every year influenza causes substantial disease and deaths, but estimating the number of deaths due to influenza is challenging as routine testing and robust surveillance for influenza is not carried out and it is rarely certified as a cause of death⁵. Significantly, out of 1.27 lakh deaths attributed to influenza per year, almost 65% of the deaths occurred among older persons above 65 yr and 15-20 per cent were among children under five⁵. This necessitates annual vaccinations of the nationally defined target groups with vaccine composition depending on the current circulating strains.

Zydus, which is one of the largest manufacturers of flu vaccines in India has been advocating preventive health and timely vaccination to prevent influenza, influenza like illnesses and other related complications in high-risk group in vulnerable population. Influenza is a highly contagious respiratory illness caused by influenza viruses which spreads from person to person, mainly through airborne respiratory droplets generated from coughing and sneezing or direct contact with an infected surface or individual.

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Prucalopride is prescribed for chronic idiopathic constipation (CIC), a condition where the cause of constipation is unknown. It helps stimulate peristalsis, natural muscle contractions in the colon, to promote more regular bowel movements. Prucalopride tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad. Prucalopride tablets had annual sales of USD 186.8 mn in the United States (IQVIA MAT June 2025).

The group now has 422 approvals and has so far filed 483* ANDAs since the commencement of the filing process in FY 2003-04.

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Bengaluru, August 7, 2025 : Zydus Lifesciences Limited (including its subsidiaries/ affiliates, hereafter referred to as “Zydus”) has received NOC (Notice of Compliance) from Health Canada for ZDS-Varenicline tablets 0.5 &1 mg. This is the group’s first NOC approval in Canada.

Varenicline is used as an aid in smoking cessation. It is a partial nicotinic acetylcholine receptor agonist, designed to partially activate this system while displacing nicotine at its sites of action in the brain.

ZDS-Varenicline tablets will be produced at Zydus Lifescience Ltd, SEZ, Ahmedabad. Varenicline tablets had annual sales of 15 mn Canadian dollar in Canada (IQVIA MAT December 2024).

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Bengaluru, June 3, 2025 : Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) today announced that it has entered into a definitive agreement with Agenus Inc. (NASDAQ: AGEN) to acquire India and Sri Lanka commercial rights for its investigational Botensilimab (BOT) and Balstilimab (BAL), combination therapy. Agenus Inc. is a clinical-stage immuno-oncology company committed to developing immune therapies that effectively combat cancer.

Agenus’ lead programme comprising Botensilimab (BOT) and Balstilimab (BAL), is a next-generation immunotherapy platform designed to strengthen and sustain the immune system’s response against tumour cells. Currently in advanced clinical trials, BOT/BAL have demonstrated significant clinical activity across nine cancer types in more than 1,200 patients, including both late-stage and neoadjuvant settings.

As a part of the agreement, Zydus will be responsible for clinical development and regulatory approvals of licensed products in these territories and will pay 5% royalty on net sales upon successful approval & commercialization.

“Our licensing partnership with Agenus aligns with Zydus’ overarching biologics vision and our aim to advance novel solutions for high-unmet need areas,” said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences. “Agenus’ robust pipeline and research in immuno-oncology along with Zydus’ reach as the largest Indian oncology player, is a significant step forward in our collective fight against cancer. We are confident that this collaboration will bring transformative therapies to patients who need them most, in India and Sri Lanka markets.”

Zydus with its strong clinical development and regulatory capabilities will not only expand the reach of BOT/BAL therapy within its initial indications but also drive its expansion into other high unmet need indications and earlier lines of treatment, as well as neoadjuvant setting.

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Bengaluru – 5 March, 2025 : Zydus, a leading, discovery-based, global lifesciences company, announces the launch of ANVIMO (Letermovir), a breakthrough in the prevention of Cytomegalovirus (CMV) infection for haematopoietic stem cell transplant (HSCT) and kidney transplant patients. ANVIMO will be available in dosages of 240 mg and 480 mg.

CMV infection remains one of the most serious complications in transplant patients, often leading to graft failure, decreased survival and prolonged hospital stays. Traditional CMV treatments, such as ganciclovir and valganciclovir, have notable limitations, including toxicity and bone marrow suppression. Letermovir provides a safer, well-tolerated, and effective alternative, offering superior safety and reduced side effects while improving transplant outcomes.

Transplantation is a life-saving but financially burdensome procedure in India. The high cost of post-transplant care, particularly CMV prophylaxis, adds to the burden. Until now, innovator Letermovir 240 mg was imported at ₹5+ lakh per month, severely limiting access. With the launch of ANVIMO, Zydus has significantly reduced the cost by 91% of the innovator price, making treatment of CMV prophylaxis significantly more affordable for Indian patients. ANVIMO has established bioequivalence with the reference drug, ensuring quality at a fraction of the cost.

Speaking on the launch, Dr. Sharvil Patel, MD of Zydus Lifesciences, said, “The introduction of ANVIMO marks a new era in bone marrow transplant and kidney transplant care in India. By making this critical therapy affordable and accessible, we are reinforcing our commitment to delivering world-class healthcare solutions. Our mission is to ensure that transplant patients get access to affordable, life-saving treatment.”

With ANVIMO, Zydus Lifesciences is transforming CMV prophylaxis in India, ensuring that more transplant patients receive timely, effective, and affordable care, ultimately improving survival rates and quality of life.

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Bengaluru, February 14, 2025 : Zydus Lifesciences Ltd., a global innovation driven healthcare company announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE has entered into an exclusive licensing, supply and commercialization agreement with Zhuhai Beihai Biotech Co., Ltd for BEIZRAY (Albumin Solubilized Docetaxel Injection), a 505(B)(2) product for the US market.

Under the terms of this agreement, Beihai Biotech will be responsible for the manufacturing and supply of the product. Zydus will be responsible for commercialization of the product in the US.  Beihai Biotech shall receive upfront payments, sales targets-based milestone payments and a share of BEIZRAY’s net profits earned in the US as per the terms of the agreement.

BEIZRAY, is the first clinically validated, improved formulation of Docetaxel without synthetic excipients like Polysorbate-80 or Sulfobutyl Ether Cyclodextrin. It is solubilized in human-derived Albumin leading to a reduction in adverse events associated with synthetic excipients. The NDA for BEIZRAY got approved in the USA on 23^rd of October 2024. BEIZRAY is indicated for the treatment of Breast Cancer, Non-small Cell Lung Cancer, Prostate Cancer, Gastric Adenocarcinoma, and Head and Neck Cancer.

Speaking on the development, President and Chief Executive Officer of Zydus Pharmaceuticals (USA) Inc., Punit Patel said, “We are pleased to partner with Beihai Biotech for the commercialization of this complex drug product in the US market. The partnership will provide impetus to our strategic focus on high unmet need therapy area, as well as our stated purpose of delivering much-needed medicines to more patients in the country. We are certain that by pooling our resources and knowledge, we will be able to empower more patients and help them lead a better quality of life.”

Dr. Qun Sun, Founder and Chairman of Zhuhai Beihai Biotech Co. Ltd, commented “The launch of BEIZRAY, the first improved Docetaxel formulation with significant clinical advantages, in the USA provides patients with an important treatment alternative for these extremely challenging conditions. We are excited about Zydus’ top position in this field and anticipate further collaborations in the future. Beihai Biotech is committed to deliver innovative and high-quality medicine for all patients through this collaboration”

The Docetaxel Injection market provides access to an annual volume uptake of approximately 531,000 units in the USA market as per the IQVIA MAT December 2024.

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Under the terms of this agreement, Synthon will be responsible for the development, manufacturing and supply of the finished product. Zydus will be responsible for the NDA submission and commercialization of the product in the US. This 505(B)(2) Oncology product will likely be filed in 2026 and will be offering additional strengths that is intended to provide reduced pill burden, flexibility for dose adjustment and enhanced patient compliance.

Speaking on the development, Managing Director of Zydus Lifesciences Ltd., Dr. Sharvil Patel said, “We are pleased to partner with Synthon for the commercialization of this complex drug product in the US market. The partnership will bring access to a high unmet need therapy area. We are certain that by pooling our resources and knowledge, we will meet critical needs of patients and stakeholders.”

Anish Mehta, CEO of Synthon BV, stated, “This 505(B)(2) product is another example of Synthon’s superior complex product development capabilities and represents a strategic move toward more complex and clinically differentiated products. We are excited to strengthen our partnership with Zydus, who will bring this critical medicine to market to provide patients with important treatment alternatives for this extremely challenging condition.”

The addressable market size of Reference Product is approximately US$1.5 billion as per IQVIA MAT Dec 2024.

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