An open label, balanced, randomized, two-formulation, two-period, two-sequence, single oral dose, crossover, bioequivalence study of test formulation (REBLESS-20) of Mankind Pharma Limited, India with reference formulation (Xarelto 20 mg) of Bayer Thai Co., Ltd. in healthy Thai volunteers under fed condition

开始日期2025-06-11

申办/合作机构

Mankind Pharma Ltd.

CTRI/2025/04/084617

/ Not yet recruitingN/A

An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioequivalence Study Comparing Resmetirom 100 mg Tablets Manufactured by Mankind Pharma Limited India With Rezdiffra Resmetirom 100 mg Tablets Distributed by Madrigal Pharmaceuticals United States of America In Healthy Human Subjects Under Fasting Condition - NIL

开始日期2025-04-21

申办/合作机构

Mankind Pharma Ltd.

TCTR20240924005

/ Completed临床1期

A Bioequivalence study of a randomized, open-label, single-dose, two-way crossover design with two-period, two-treatment and two-sequence of Test formulation (EMPAKIND 25) of Mankind Pharma Limited, India and reference formulation (Jardiance) of Boehringer Ingelheim (Thai) Ltd. in healthy Thai volunteers under fasting condition

开始日期2024-10-30

申办/合作机构

Mankind Pharma Ltd.

100 项与 Mankind Pharma Ltd. 相关的临床结果

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项与 Mankind Pharma Ltd. 相关的文献（医药）

2025-06-01·Bioorganic Chemistry

Identification and evaluation of cyclic urea based 4H-triazolo pyridine substituted derivatives as novel ASK1 inhibitors

Article

作者: Kumar, Anil ; Kumar, Rakesh ; Rai, Santosh Kumar ; Sharma, Kalicharan ; Patil, Rakesh Ishwar ; Panwar, Amit ; Khan, Imran

Apoptosis signal-regulating kinase 1 (ASK1) is a member of MAPK signaling pathway and implicated in numerous human diseases including hepatic injury. In the current study we have designed and synthesized 4H-triazolo pyridine substituted derivatives as novel ASK1 inhibitors. Evaluation of multiple synthesized compounds in in-vitro cell-free assay for best compounds (29, IC₅₀ = 4.1 nM; 33, IC₅₀ = 3.6 nM; 35, IC₅₀ = 1.8 nM) and cell based assay (29, IC₅₀ = 139.5 nM; 33, IC₅₀ = 69.2 nM; 35, IC₅₀ = 15.1 nM) led us to identify potent ASK1 inhibitors 29, 33 and 35. Therapeutic potential of these selected compounds (29, 33 and 35) was tested in preclinical mouse model of acetaminophen (APAP)-induced hepatic injury. All compounds exhibited significant protection against hepatotoxicity as evident from reduction in plasma ALT levels. Further, all these compounds displayed a notable metabolic stability in mouse hepatocytes and exhibited excellent safety profile as no significant CYP450 or hERG channel inhibition was found. Overall, these results indicated that our compounds are potent ASK1 inhibitors and have therapeutic potential to protect the liver against critical damage.

2025-02-17·Cureus

Efficacy and Safety of Albendazole Versus Albendazole and Ivermectin in Reduction of Soil-Transmitted Helminth Infections in School-Age Children: A Double-Blind, Randomized, Controlled Trial

Article

作者: Nandy, Mausumi ; Gitika ; Singal, Rajat ; Yadav, Ravinder ; Mitra, Monjori ; Datta, Kalpana ; Awasthi, Shally

BACKGROUNDSoil-transmitted helminth (STH) infections are endemic in India despite considerable improvements in hygiene conditions and regular deworming. This multicentric, double-blind, randomized controlled trial (Efficacy and Safety of Albendazole Versus AlbenDazole and IVERmectin in Reduction of Soil-Transmitted HelMINth Infections in School-Age Children (DVERMIN)) was conducted to evaluate the efficacy and safety of albendazole versus albendazole + ivermectin in the treatment of STH infections and to evaluate the prevalence of stool-positivity for STH in school-going children from 12 schools of Lucknow and Kolkata.METHODSThis was a randomized controlled trial conducted from March 2022 to February 2023. The included children aged 6-15 years were administered single-dose oral suspension of albendazole (400 mg) or albendazole (400 mg) + ivermectin (3/6/12 mg based on body weight). The primary endpoint was the microbiological cure rate (proportion of infected children having egg-free stool samples post single-dose treatment) on Day 7. The secondary endpoints were egg reduction rate and clinical cure rate (proportion of children with symptom resolution) on Day 7, and the proportion of children in the regions of study conduct with stool positivity for STH at baseline. Safety was assessed based on adverse events (AEs).RESULTSAmong the 1233 eligible children, stool samples from 1067 were evaluable at baseline. A total of 416 (38.99%) of these 1067 samples were egg-positive. Ascaris lumbricoides was the most prevalent STH (99.52% samples). Of the 416 samples, 304 were evaluable for post-dose analysis (albendazole, 146; albendazole + ivermectin, 158). In these samples, the microbiological cure rate achieved with albendazole (61.64%) was comparable to that achieved with albendazole + ivermectin (62.03%; p=0.95). The egg reduction rate obtained with albendazole was 90.61% compared to 93.22% achieved with albendazole + ivermectin. The rate of complete clinical cure on Day 7 was 66.95% with albendazole and 71.31% with albendazole + ivermectin (p=0.47). A moderate AE unrelated to antihelminthic medication was observed with albendazole; no AE was observed with albendazole + ivermectin.CONCLUSIONSOverall, both treatments were found to be effective and safe in school-age children. The rates of microbiological cure, egg reduction, and clinical cure were not significantly different between the groups; however, a clinical advantage was demonstrated in the albendazole + ivermectin group with respect to egg reduction and clinical cure.

2025-01-01·Poultry Science

Effects of organic acid blends on the growth performance, intestinal morphology, microbiota, and serum lipid parameters of broiler chickens

Article

作者: Datar, Yashwant ; Kadam, M M ; Korde, J P ; Bahiram, K.B. ; Kadam, M.M. ; Rajora, Pushpendra ; Korde, J.P. ; Bhat, Rekha ; Gupta, Mahesh ; Kurkure, N V ; Kurkure, N.V. ; Bahiram, K B ; Waghmare, Swapnali ; Kaore, Megha

Organic acids have emerged as promising alternatives to antibiotic growth promoters in poultry production. The present study was conducted to determine the effects of organic acids blends v.i.z. Acidapure liquid and Acidapure powder supplementation on the growth performance, gut health, gut microbiota, and serum lipid profile of broiler chickens. A total of 120-day-old chicks with similar live body weights were randomly divided into four groups. Each group was further divided into 3 replicates, and each further divided into three replicates of ten bird. The birds in Group 1 (T1) were fed a basal diet supplemented with plain drinking water, those in Group 2 (T2) received basal feed supplemented with Acidapure powder (1 kg/MT feed) and plain drinking water, those in Group 3 (T3) received basal feed supplemented with Acidapure liquid in the drinking water (0.2 ml/l water), and those in Group 4 (T4) received basal feed supplemented with Acidapure powder (1 kg/MT feed) and Acidapure liquid in the drinking water (0.2 ml/l water). Acidapure powder and Acidapure liquid were added to the feed and water of the broilers from 0-42 days of life. The results showed that compared with the control (T1), supplementation with Acidapure powder and liquid in broiler chickens for 42 days increased (P < 0.05) ABW and ADG and reduced FCR in the treatment groups (T2, T3 and T4). At d 21 and 42, all forms of Acidapure supplement increased the VH and CD in the jejunum and ileum and reduced the pH of the ileum. Compared with the control (T1), the combination of Acidapure powder and liquid (T4) increased the gene expression of the tight junction proteins Claudin-1 and Zona Occludense 1 (ZO-1). Compared with the control, Acidapure supplementation reduced the cecal coliform count and total viable count (TVC) and decreased the serum cholesterol and triglyceride levels. In conclusion, Acidapure, as a blend of organic acids, effectively enhances the growth performance and gut health of broilers, making it a viable and safe alternative to traditional antimicrobial growth promoters.

项与 Mankind Pharma Ltd. 相关的新闻（医药）

2025-02-14

·PRNewswire

Biologics Conference 2025 Concludes Successfully, Setting New Benchmarks in Biopharmaceutical Innovation and Collaboration

MUMBAI, India, Feb. 14, 2025 /PRNewswire/ -- The Institute of Chemical Technology, Mumbai, in collaboration with the Mumbai Biocluster, successfully hosted the 5th Annual Summit of Biologics Conference and Workshops focused on Biopharmaceutical Product Development on January 30-31, 2025, at the Novotel Dona Sylvia Resort, Goa. This landmark event has evolved into a premier platform bringing together key stakeholders for scientific exchange, business networking, and industry advancement. From right to left: Dr. Sanjay Singh, CEO of Gennova Pharmaceuticals, Mr. Satish Hiremath, Managing Director - Koncepo Scientech International, Dr. Subodh Deshmukh, CEO - Aragen Bioscience Inc., Dr. Rahul Singhvi, Co-founder - National Resilience, Dr. Prem Pavoor, Managing Partner - Eight Roads, Mr. Sanjeev Navangul, Managing Director and CEO - Bharat Serum and Vaccines, Dr. Cyrus Karkaria, President - Lupin, Mr. Atin Tomar, CEO - Yapan Bio, Dr. Himanshu Gadgil, CEO - Enzene, Dr. Prabuddha Kundu, Co-founder and Managing Director - Premas Biotech, Dr. Anurag Rathore, Professor - IIT-Delhi, Dr. Rajesh Gokhale, Secretary - DBT-GOI, Dr. Manoj R. Panicker, General Manager (South Asia) - Cytiva, Dr. Gautham Nadig, Co-founder and Executive Director - Mynvax Pvt Ltd, Mr. Dhananjay Nawandar, Co-founder - VJ Bioscience, Mr. Nitin Deshmukh, Senior Advisor - Kotak Equity, Prof. A. B. Pandit, Vice Chancellor - ICT, Mumbai, Mr. Krishna Chandran, Technical Director (Bioprocess Solutions) - Sartorius Stedim, Dr. Sridevi K., CEO - Shilpa Biologicals, Conference Convener Dr. Ratnesh Jain, Managing Director - Mumbai Biocluster.

2024-12-27

·氨基观察

第一三共TROP2 ADC全球首批；信达生物PD-1出海印度

氨基观察-创新药组原创出品作者 | 黄凯第一三共ADC布局又有新收获。 12月27日，第一三共宣布， TROP2 ADC德达博妥单抗在日本获批上市，用于既往接受过化疗治疗的不可切除或转移性HR阳性、HER2低表达或阴性乳腺癌成人患者。这也是德达博妥单抗的全球首批。信达生物PD-1出海印度。 12月26日，印度第四大制药企业Mankind Pharma 宣布，和信达生物建立合作伙伴关系，在印度市场获得信达生物PD-1药物信迪利单抗的独家授权和商业化权益。那么，信迪利单抗将会在印度表现如何呢？在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 市场速递 1）JAK抑制剂巴瑞替尼化合物和晶型专利均已被宣告全部无效日前，国家知识产权局针对礼来的一篇化合物晶型专利201610136379.8发出无效宣告请求审查决定书，宣告JAK抑制剂巴瑞替尼专利权全部无效。无效宣告请求人为南京力博维制药有限公司。 2）信达生物PD-1出海印度 12月26日，印度第四大制药企业Mankind Pharma 宣布，和信达生物建立合作伙伴关系，在印度市场获得信达生物PD-1药物信迪利单抗的独家授权和商业化权益。 / 02 / 资本信息 1）浩博医药宣布完成7300万美元B轮融资 12月27日，浩博医药宣布完成7300万美元B轮融资。本轮融资将主要用于推进核心小核酸创新药物AHB-137的中国和国际临床试验, 以及早期商业化的准备工作。此外，资金还将支持公司新研发管线的拓展及团队的持续发展和建设。 2）亚盛医药完成纳斯达克IPO备案日前，证监会对亚盛医药赴美IPO的上市备案予以确认。亚盛医药拟发行不超过33,739,347股普通股，并在美国纳斯达克证券交易所上市。 / 03 / 医药动态 1）天坛生物终止静注COVID-19人免疫球蛋白研发 12月27日，天坛生物公告，公司决定终止静注COVID-19人免疫球蛋白（pH4的Ⅱ期临床试验研究及后续研发。该药物研发投入共计1.21亿元，包括研究开发费和设备购置费。 2）正大天晴贝莫苏拜单抗联合疗法一线肺鳞癌Ⅲ期临床成功 12 月 27 日，正大天晴宣布，贝莫苏拜单抗联合化疗后序贯联合盐酸安罗替尼胶囊一线治疗晚期鳞状非小细胞肺癌的Ⅲ期临床研究（TQB2450-Ⅲ-12）取得阳性结果。 3）康哲美丽磷酸泊沃昔替尼未获批准 12月27日，据NMPA官网，康哲美丽磷酸泊沃昔替尼收到通知件，意味着未获批准。 / 04 / 器械跟踪 1）和华瑞博医疗关节置换手术导航定位系统获注册批件 12月27日，据NMPA官网，和华瑞博医疗关节置换手术导航定位系统获注册批件。 2）柯惠医疗外周自膨式支架系统获注册批件 12月27日，据NMPA官网，柯惠医疗外周自膨式支架系统获注册批件。 3）波科国际心脏消融系统获注册批件 12月27日，据NMPA官网，波科国际心脏消融系统获注册批件。 / 05 / 海外药闻 1）第一三共TROP2 ADC在日本获批上市 12月27日，第一三共宣布， TROP2 ADC德达博妥单抗在日本获批上市，用于既往接受过化疗治疗的不可切除或转移性HR阳性、HER2低表达或阴性乳腺癌成人患者。 2）强生引进临床前STAT6抑制剂 12与26日，强生宣布，引进日本药企Kaken Pharmaceutical的临床前阶段STAT6抑制剂KP-723的日本外全球权益，首付款为3000万美元，里程碑款为12.175亿美元，以及个位数至低双位数比例的销售分成。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

临床3期抗体药物偶联物IPO申请上市临床2期

2024-12-27

·Pharmaceutical Technology

Mankind Pharma and Innovent partner for Sintilimab commercialisation in India

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.

引进/卖出免疫疗法并购临床3期上市批准

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药物(靶点)	适应症	全球最高研发状态

尿激酶生物类似药(Bharat Serums & Vaccines Ltd.) ( PLG )	肺栓塞更多	批准上市
链激酶生物类似药(Bharat Serums & Vaccines Ltd.) ( PLG )	肺栓塞更多	批准上市
促卵泡激素生物类似药(Bharat Serums & Vaccines Ltd.) ( FSHR )	不孕更多	批准上市
Trinbelimab ( Rh factor )	-	临床前
MKP-10241 ( GPR119 )	2型糖尿病更多	无进展