Bharat Serums & Vaccines Ltd.

Under the agreement, Mankind Pharma will have the exclusive rights to register, import, market, sell, and distribute Sintilimab in India. Credit: Piotr Swat/Shutterstock. Mankind Pharma has entered into a partnership with Innovent Biologics for exclusively licensing and commercialising Sintilimab, an immunotherapy for cancer treatment in India. This strategic move is aimed at addressing significant challenges in cancer care and enhance patient access to new therapeutic options. Sintilimab, known as TYVYT (sintilimab injectable) in China, was developed through a collaboration between Eli Lilly and Innovent. Currently, the asset is not approved in India, IIFL Capital reported. Earlier next year, Mankind Pharma plans to seek regulatory approval in India and complete all regulatory processes, including the conduct of a Phase III study in the country. The study will commence once the company receives regulatory approval to conduct such studies. Under the agreement, Mankind Pharma will have the exclusive rights to register, import, market, sell, and distribute Sintilimab in India. Innovent will oversee the manufacturing and supply of the product to ensure steady availability and adherence to quality standards. Innovent Biologics chief business officer Samuel Zhang said: “The company is committed to advancing patient care in India by making cutting-edge treatments more accessible and affordable.” In July 2024, Mankind Pharma entered into a definitive agreement to acquire 100% of Bharat Serums and Vaccines (BSV) from private equity investor Advent International for an enterprise value of approximately Rs136.3bn ($1.59bn). Bharat Serums, a biopharmaceutical company founded in 1971, has a research and development centre in the Indian city of Mumbai with over 100 scientists. It operates in more than 70 countries, with subsidiaries in Germany, the Philippines, and the US.

Globally, only half of the Women get treatment for the Rh disease and may be linked to the deaths of more than 1,00,000 foetuses and newborns worldwide* NAIROBI, Kenya, Dec. 11, 2024 /PRNewswire/ -- The Rh factor (Rhesus factor) is a red blood cell surface antigen also known as Rh disease, is a condition that occurs when a woman with Rh-negative blood type is exposed to Rh-positive blood cells, leading to the development of Rh antibodies. Rh incompatibility can occur in 2 ways. The most common type occurs when a Rh-negative pregnant mother is exposed to Rh-positive fetal red blood cells secondary to fetomaternal haemorrhage during pregnancy from spontaneous or induced abortion, trauma, invasive obstetric procedures, or normal delivery. Continue Reading Experts raising awareness on HDFN A treatment developed over 50 years ago to prevent Rh disease—an often-fatal condition in foetuses and newborns—only reaches half of the women in the world who need it, according to a study led by researchers at Vagelos College of Physicians and Surgeons (VP&S) at Columbia University Irving Medical Centre*. Leading doctors appreciated the impact and effectiveness of this treatment but are concerned about its access and reach. "This treatment is the standard of care for preventing Rh disease, but we recognize that there remain significant obstacles to expanding access to this lifesaving therapy around the world," says Spitalnik, who has been working with an international team of physicians to increase access to therapy with Rh(D) immunoglobulin around the world. * Improved access which currently is a challenge, could change the outcomes dramatically, saving lives. Hence there is an utmost need to highlight the role of antenatal care and its crucial role in prevention of Rh diseases across African region. So, what is the problem and Role of Antenatal care and Collaborative strategies from KOGS and govt institution/insurance organisation for supporting Rh disease prevention in Kenya? "According to our research in Kenya, the prevalence of Rhesus negativity among pregnant women is significantly higher than previously believed and varies by county. The range is between 6-10%, inconsistent with prior reports that claimed an average of 4%. This suggests that the need for treatment is likely to increase and the government must put policies in place to meet this demand" said Dr. Moses Obimbo, a Professor at the University of Nairobi and KOGS Hon Secretary. According to KOGS, Rhesus isoimmunization : an underappreciated reproductive risk, article published in JOGECA 2023, there has been a contentious suggestion for the universal prophylactic use of anti-D immunoglobulin in all pregnancies, including those following termination or ectopic pregnancies. Despite being preventable, Rhesus disease was identified as one of the roadblocks to achieving maternal universal health coverage. The team recommended all stakeholders to facilitate access to anti-D immunoglobulin and screening tools for widespread screening and treatment.^ Such measures would go a long way in prevention of Rh disease. The first step in creating awareness though is also the simple knowledge of one's own blood groups and Rh testing. Knowing your Rh status reduces these risks dramatically Rh sensitization is evaluated by a blood test known as indirect Coombs' test. This test can assess presence of cell-destroying antibodies and alert the doctor to take appropriate treatment. Effects of Rh incompatibility can be prevented by getting an injection of RhIg (Rh immunoglobulin,) during the first course of pregnancy, abortion, miscarriage, while having any bleeding during pregnancy or within 72 hours of delivery. Importance of Blood group testing in pregnant women "Uganda has made significant strides in the reduction of maternal mortality from haemorrhage and hypertensive disorders of pregnancy. However, we should not forget the morbidity and suffering caused by Rhesus incompatibilities during all trimesters of pregnancy and after childbirth. Make Blood group/Rhesus testing an indicator of quality of care at all levels offering care to women" said Dr. Othiniel Musana, Member Senior Leader Team National Safe Motherhood Expert Committee (NASMEC), President of Association of Obstetricians and Gynaecologists of Uganda (AOGU) 2021-2023. How is Rh incompatibility managed? If a Rh-negative woman is pregnant and has given birth to a Rh-positive child in the past, the doctor can test for Rh positive antibodies in her blood, and even take a sample of amniotic fluid to check for bilirubin levels in the fetus (amniocentesis). It is possible to take a sample of fetal blood from the umbilical cord as well. Once diagnosed, depending on the severity of the disease, the fetus may either require single or multiple intrauterine blood transfusions or it may have to be delivered early to manage complications. Haemolytic disease of the newborn is a devastating disease for babies and their families and is a huge challenge to handle. But it does not have to be. Being forewarned is being forearmed and awareness of this condition can go a long way in saving lives Collaborative strategies from AGOTA with govt institution/insurance organisation for supporting Rh disease prevention. "The association of Gynaecologists and Obstetricians of Tanzania (AGOTA) has worked very closely with the Government and other health concerned stakeholders like BSV in preparing guidelines, mentoring and evaluating of all issues pertaining to maternal newborn and child health including Rh incompatibility. The awareness of antenatal care in Tanzania is of paramount with the aim of solving the existing challenges of provision of antenatal care services focusing on improving maternal and perinatal outcome. The Government of Tanzania priority is to insure universal, quality, comprehensive and equitable health services to all of its citizens, with much emphasis on improving health status of women and children" said Dr. Matilda Ngarina - AGOTA President. *Source : ^ Obimbo, M., & Omanwa, K. (2023). Rhesus isoimmunization: An underappreciated reproductive risk. Journal of Obstetrics and Gynaecology of Eastern and Central Africa, 35(2), 74. 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The acquisition is anticipated to bolster Mankind Pharma’s position in the Indian women’s health and fertility drug market. Credit: fizkes / Shutterstock. Mankind Pharma has announced a definitive agreement for the acquisition of a 100% stake in Bharat Serums and Vaccines (BSV) from private equity investor Advent International in a Rs136.3bn ($1.6bn) deal. The move bolsters Mankind Pharma’s position in the Indian women’s health and fertility drug market. The deal will also aid Mankind Pharma in providing access to high-barrier products in critical care leveraging complex research and development (R&D) tech platforms. BSV, with more than five decades of expertise in biopharmaceuticals, has an established presence with its in-house developed recombinant and niche biologic products. The company’s branded product portfolio spans women’s health, fertility and critical care, with several leading brands in their respective therapy areas. See Also: FDA committee proposes overhaul of perioperative lung cancer trials Mankind Pharma vice-chairman and managing director Rajeev Juneja stated: “BSV’s acquisition represents a pivotal milestone in Mankind’s journey, establishing us as a market leader in the Indian women’s health and fertility segment. We believe the women’s health and fertility segment has massive opportunity along with strong growth visibility globally, led by structural tailwinds. “BSV’s established speciality R&D tech platforms with a complex portfolio across women’s health, fertility, critical care and [the] immunoglobulin segment perfectly aligns Mankind Pharma’s strategic vision to expand its footprint in high entry barrier portfolio. We are also delighted to welcome BSV’s 2,500+ members to our Mankind family.” The acquisition includes BSV’s comprehensive portfolio in women’s health, covering the reproductive lifecycle from fertility to post-pregnancy. Its significant portfolio in the fertility segment will aid in scaling in both Indian and international markets, especially with the increasing penetration of in vitro fertilisation (IVF) treatments. Mankind Pharma CEO and whole-time director Sheetal Arora stated: “Mankind’s strategic acquisition of BSV with branded speciality pharma portfolio across India and emerging markets presents immense growth potential and will add to the existing growth velocity of Mankind.”