Zydus Lifesciences Limited (formerly Cadila Healthcare Limited)
Indian multinational pharmaceutical company headquartered in Ahmedabad, engaged in manufacturing generic drugs, vaccines, diagnostics and other healthcare products; renamed from Cadila Healthcare Limited in 2022. Ranked 100th in the Fortune India 500 list in 2020.
相关临床试验
68
26 进行中
药物批准
689
批准总数
监管机构
6
监管机构数
成立时间
1952
进行中（未招募）
9
13.2%
已完成
30
44.1%
尚未招募
17
25.0%
招募中
9
13.2%
暂停
1
1.5%
终止
2
2.9%
- Lupin has secured approval to manufacture and market its pegfilgrastim biosimilar in India, with production planned at its Nagpur facility in Maharashtra. - Pegfilgrastim is an onco-supportive therapy that helps the body produce neutrophils after chemotherapy to reduce the risk of serious infections and fever. - Lupin's Armlupeg is already approved in the US, where commercial rights are out-licensed to Valorum Biologics, while Biocon and Amneal also market US pegfilgrastim biosimilars.
- Zydus Lifesciences received final USFDA approval for its Ascorbic Acid Injection USP in strengths of 25,000 mg/50 mL and 5,000 mg/10 mL (500 mg/mL). - The injection is indicated for short-term treatment of scurvy in adult and pediatric patients aged 5 months and older when oral administration is not feasible. - The USFDA granted 180 days of Competitive Generic Therapy (CGT) exclusivity, commencing from the first day of commercial marketing. - The product, a generic equivalent of McGuff Pharmaceuticals' Ascor (annual US sales of about $11.6 million), will be manufactured at Zydus' Jarod facility in Gujarat.
- Sentynl Therapeutics and Mereo BioPharma have entered into an option and license agreement granting Sentynl U.S. commercial rights to alvelestat, a potential first-in-class oral neutrophil elastase inhibitor for AATD-LD. - Mereo will receive an upfront option fee and, upon option exercise, up to $40 million in upfront and R&D payments until NDA filing, plus double-digit tiered royalties on U.S. net sales. - Alvelestat is being readied for a global Phase 3 study, backed by positive efficacy data from two Phase 2 studies, with initiation potentially in early 2027. - AATD-LD is a rare genetic respiratory disease affecting an estimated 50,000–80,000 individuals in the United States, with no approved oral therapy currently available.
- Zydus Lifesciences received final USFDA approval for its ANDA for Indocyanine Green for Injection, USP, 25 mg/vial, a generic equivalent of Diagnostic Green's IC-Green. - The USFDA designated the application as a Competitive Generic Therapy (CGT), making it potentially eligible for 180-day marketing exclusivity upon first commercial launch. - The reference product recorded annual U.S. sales of approximately $125.8 million with 61% year-on-year growth, according to IQVIA MAT June 2026 data. - The product is an optical imaging agent used for fluorescence imaging across vascular, oncologic, transplant, and reconstructive surgeries in adults and certain pediatric patients.
- Zydus Lifesciences has received regulatory approval to conduct a Phase III clinical trial of oral desidustat in 164 patients with sickle cell disease, in collaboration with the Indian Council of Medical Research (ICMR). - The 203-day study follows a successful Phase II trial in which the 150 mg dose demonstrated promising hemoglobin improvement with minimal adverse events. - Desidustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI), stimulates endogenous erythropoietin production and iron utilization, offering a novel oral mechanism for treating anemia in sickle cell disease. - The drug is already approved in India and China for renal anemia and holds US FDA Orphan Drug Designation for sickle cell disease, positioning it for potential global development.
- The global NASH treatment market is projected to grow from USD 8.75 billion in 2025 to USD 46.87 billion by 2032, expanding at a CAGR of 27.1%. - Madrigal's Rezdiffra, approved in March 2024, created the first dedicated liver-directed prescription pathway for noncirrhotic NASH with moderate-to-advanced fibrosis. - Novo Nordisk's Wegovy gained FDA approval in August 2025 for MASH with F2–F3 fibrosis, connecting liver treatment to established obesity and diabetes care networks. - Late-stage pipeline candidates from Eli Lilly, Akero Therapeutics, 89bio, Inventiva, and Boehringer Ingelheim could create a multi-mechanism, segmented treatment market.
- The global biosimilar market expanded fifteen-fold from US$2.2 billion in 2016 to roughly US$32.7 billion in 2024, with Korea and India serving as its manufacturing engine room. - Despite record revenues at Celltrion, Samsung Bioepis, and Biocon, APAC manufacturers face a structural "value trap" where US pharmacy benefit managers capture the economic upside through private-label biosimilars. - The FDA is dismantling interchangeability requirements, proposing to eliminate comparative clinical efficacy studies, which simultaneously lowers development costs and erodes product differentiation. - Some 118 biologics worth US$232 billion in US sales lose exclusivity through 2034, yet only 10% have a biosimilar in active development, revealing a "biosimilar void" driven by poor return economics.
- Zydus Lifesciences signed an MoU with Apollo Hospitals to offer the Shield Multi-Cancer Detection blood test across India, leveraging its exclusive agreement with Guardant Health. - The methylation-based blood test screens for 10 cancer types—including breast, colorectal, liver, and lung—in individuals aged 45 and older at average risk. - The Shield MCD test has received FDA Breakthrough Device Designation, recognizing its potential to improve cancer screening over existing options. - India recorded over 1.41 million new cancer cases and more than 900,000 deaths in 2022, yet screening rates remain low with wide regional disparities.
- India's Union Health Ministry has proposed replacing the import license requirement (Form 11) with a simpler acknowledgement-based system for drugs imported in small quantities for analytical and non-clinical testing. - The simplified procedure will not apply to biologics, beta-lactam drugs, sex hormones, cytotoxic drugs, and narcotic substances, which will continue to require prior licensing. - The draft amendment follows a similar January 2026 relaxation for domestic test licenses and reduces the processing timeline for new drug manufacturing applications from 90 to 45 days. - The initiative aims to reduce regulatory burden, accelerate drug development, and support startups and industries in quickly initiating testing or analysis.
- The US FDA granted Priority Review to Zydus Therapeutics' New Drug Application for saroglitazar to treat primary biliary cholangitis, with a target action date of November 27, 2026. - The EPICS-III Phase 3 trial demonstrated that 56.7% of patients achieved biochemical response with saroglitazar versus 9.8% with placebo, representing a 48% treatment difference. - Saroglitazar significantly reduced alkaline phosphatase levels by 33.5% compared to a 6.5% increase in the placebo group, addressing a key surrogate marker for long-term outcomes. - If approved, Zydus plans to launch saroglitazar in the United States by March 2027 for patients with inadequate response to current standard therapy.
