Aurobindo Pharma Ltd

CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys' (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers. Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells. Aurobindo Pharma's Vice Chairman and Managing Director Mr. Nithyananda Reddy said, The CHMP's positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts in building biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies. Powered by Capital Market - Live

The drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets by Bristol-Myers Squibb Company (BMS). Dasatinib is approved for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults and children, including newly diagnosed cases. It is also indicated for Ph+ CML with resistance or intolerance to prior therapies like imatinib and for Ph+ acute lymphoblastic leukemia (ALL) with treatment resistance or intolerance. The approved product has an estimated market size of US$ 1.8 billion for the twelve months ending February 2025, according to IQVIA MAT. This marks the 181st ANDA approval (including 9 tentative approvals) from Eugia Pharma Specialties Group (EPSG) facilities, which manufacture both oncology oral and sterile specialty products. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries. The company's consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024.Powered by Capital Market - Live

The said drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), XARELTO, 2.5 mg of Janssen Pharmaceuticals Inc. Rivaroxaban Tablet USP is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE, for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery. Rivaroxaban Tablets USP, 2.5mg, has an estimated US market size of $447 million for the twelve months ending February 2025, according to IQVIA. The company now has a total of 540 ANDA approvals (521 Final approvals and 19 tentative approvals) from USFDA. The company has also received tentative approval from USFDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tablets USP, in the US, is $8.5 billion for the twelve months ending February 2025, according to IQVIA. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company's consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024.Powered by Capital Market - Live

The said drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), XARELTO, 2.5 mg of Janssen Pharmaceuticals Inc. Rivaroxaban Tablet USP is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE, for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery. Rivaroxaban Tablets USP, 2.5mg, has an estimated US market size of $447 million for the twelve months ending February 2025, according to IQVIA. The company now has a total of 540 ANDA approvals (521 Final approvals and 19 tentative approvals) from USFDA. The company has also received tentative approval from USFDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tablets USP, in the US, is $8.5 billion for the twelve months ending February 2025, according to IQVIA. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company's consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024. The scrip added 2.47% to end at Rs 1,082.55 on Friday, 11 April 2025. The stock market will remain closed today on account of Dr. Babasaheb Ambedkar Jayanti.Powered by Capital Market - Live

Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) has conducted an inspection at Raleigh Plant, North Carolina, USA, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company, established for manufacturing Inhalers and Derma products, from 24 March 2025 to 10 April 2025. The inspection was completed on 10 April 2025 and at the conclusion, the USFDA issued a Form 483 with 11 observations. These observations are procedural in nature.Powered by Capital Market - Live

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, announced that its denosumab biosimilar, BP16, has successfully met the primary endpoints in a comprehensive pharmacokinetic (PK) and pharmacodynamic (PD) study. This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia', obtained from both the EU and US markets. Dr. Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, stated, 'The results from our study confirmed that BP16 exhibits a PK profile nearly identical to the reference products, achieving key bioequivalence parameters'maximum serum concentration and area under the curve'within the established bioequivalence range of 80 -125 percent. Additionally, BP16 demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product. The study, which included 204 subjects from Australia and New Zealand, successfully met all the predefined endpoints.' Denosumab works by specifically targeting the RANK ligand (RANKL), a critical protein in the lifecycle of osteoclasts, the cells that break down bone. Denosumab's ability to inhibit RANKL makes it highly effective in treating conditions linked to bone loss, such as osteoporosis in postmenopausal women, bone metastases from cancers, and cancer treatment-related bone health issues. 'With the positive Phase 1 study results, we are optimistic about our ongoing Phase 3 study. This study is progressing across multiple sites in the EU, focusing on women with postmenopausal osteoporosis, and we anticipate its completion by May/June 2025, said Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics. We aim to submit a Marketing Authorization application to CHMP/EMA in the third quarter of this fiscal year.' Powered by Capital Market - Live

The committee for medicinal products (CHMP) of the European Medicines Agency had adopted a positive opinion, recommending the approval of Dyrupeg. Dyrupeg is a biosimilar medicine containing the active substance pegfilgrastim, intended to reduce the duration of neutropenia and prevent febrile neutropenia in adult cancer patients treated with cytotoxic chemotherapy. Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services. Aurobindo Pharma reported a 10.04% decline in consolidated net profit to Rs 845.57 crore in Q3 FY25, compared to Rs 939.97 crore posted in Q3 FY24. Revenue from operations increased 8.53% year on year (YoY) to Rs 7,978.52 crore in the quarter ended 31 December 2024. Shares of Aurobindo Pharma fell 1.40% to currently trade at Rs 1,089.35 on the BSE.Powered by Capital Market - Live

K P R Mill Ltd, Gland Pharma Ltd, Cipla Ltd, Lupin Ltd are among the other stocks to see a surge in volumes on BSE today, 03 April 2025.Aurobindo Pharma Ltd registered volume of 1.89 lakh shares by 10:47 IST on BSE, a 8.81 fold spurt over two-week average daily volume of 21456 shares. The stock rose 2.07% to Rs.1,182.60. Volumes stood at 16577 shares in the last session.K P R Mill Ltd clocked volume of 47258 shares by 10:47 IST on BSE, a 5.95 times surge over two-week average daily volume of 7947 shares. The stock gained 7.03% to Rs.1,028.10. Volumes stood at 30349 shares in the last session.Gland Pharma Ltd saw volume of 59207 shares by 10:47 IST on BSE, a 5.93 fold spurt over two-week average daily volume of 9986 shares. The stock increased 3.40% to Rs.1,587.35. Volumes stood at 3058 shares in the last session.Cipla Ltd recorded volume of 90152 shares by 10:47 IST on BSE, a 3.96 times surge over two-week average daily volume of 22780 shares. The stock gained 2.91% to Rs.1,495.00. Volumes stood at 15171 shares in the last session.Lupin Ltd clocked volume of 64384 shares by 10:47 IST on BSE, a 3.67 times surge over two-week average daily volume of 17527 shares. The stock gained 3.61% to Rs.2,082.00. Volumes stood at 22646 shares in the last session.Powered by Capital Market - Live

Curateq Biologics, a wholly owned subsidiary of Aurobindo Pharma, has allotted 4,125,055 Compulsory Convertible Preference Shares (CCPSs) of Rs.10/- each to Dr. Satakarni Makkapati on 20 March  2025. Each CCPS is convertible into a maximum of one equity share of Rs.10/- each and on conversion into Equity Shares Dr. Satakarni Makkapati will be holding 2% of Equity Share capital of Curateq and Curateq will then cease to be a wholly owned subsidiary of the Company and continue as a subsidiary of the Company. Dr. Satakarni Makkapati is Chief Executive Officer of Curateq and a Director of Aurobindo Pharma. Powered by Capital Market - Live

Aurobindo Pharma announced that the U.S. Food and Drug Administration (US FDA) had conducted an inspection at the Unit-V, an API manufacturing facility, of Apitoria Pharma, a wholly owned subsidiary of the Company, situated at Pashamylaram Village, Patancheru Mandal, Sanga Reddy District, Telangana from 09 December to 17 December 2024. The Unit has now received Establishment Inspection Report classifying the facility as Voluntary Action Indicated (VAI). Powered by Capital Market - Live