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Innovation Excellence is unleashed when ideas are spurred by action, making the impossible happen.

As a research-based pharmaceutical company, Zydus' Innovation programme is spearheaded by 1400 researchers across 19 sites, working on differentiated medicines for the future. From NCEs to vaccines, biosimilars and niche technologies, the group is exploring different ideas, concepts and continuously innovating.

Major Areas of Research:

NCE Research NCE RESEARCH
  • Cardio-Metabolic diseases
  • Inflammation & pain
  • Oncology
Biologics BIOLOGICS
  • Biosimilar Therapeutic proteins
  • Biosimilar Monoclonal antibodies
  • Biobetters and Novel biologics
Vaccines VACCINES
  • Infectious diseases
Research Spectrum

NEW CHEMICAL ENTITIES

The Zydus Research Centre (ZRC) is the dedicated research arm of the Zydus Group. With its team of over 400 research professionals, ZRC spearheads the group’s quest of creating healthier and happier communities globally. Spread over an area of over 4,75,000 sq ft, ZRC is working on cutting edge technologies in different scientific disciplines to discover novel therapeutic agents. The centre has capabilities to conduct drug discovery & development from concept to IND enabling preclinical and clinical studies.

In 2013, the group was the first to identify, develop and launch LipaglynTM (Saroglitazar) the novel drug to treat diabetic dyslipidemia – a global, unmet healthcare need. Lipaglyn is the first NCE from an Indian research pipeline to move from the lab to the market. It offers dual benefits of lipid and glycemic control in one single molecule. It is an innovation that has helped over 700000 people suffering from diabetic dyslipidemia in India lead healthier lives.

Lipaglyn™ (Saroglitazar Mg) currently approved in India is a prescription medicine for the treatment of Hypertriglyceridemia and Diabetic Dyslipidemia in Patients with Type 2 Diabetes not controlled by statins. The recommended dose of Lipaglyn™ is 4 mg once-a-day.

Zydus Lipaglyn

Saroglitazar Mg is an investigational new drug in the United States and is currently being evaluated in Phase II clinical trials for the treatment of Severe Hypertriglyceridemia (TG > 500) and Non-Alcoholic SteatoHepatitis (NASH).

Hypertriglyceridemia Diabetic Dyslipidemia NASH Lipodystrophy Type 2 Diabetes

* Lipaglyn is a prescription drug authorised for sale in India only and can be taken only under the advice and guidance of a registered medical practitioner.

NON-ALCOHOLIC STEATOHEPATITIS (NASH)

Zydus has initiated a 52 week Phase III clinical trial of Lipaglyn™ in patients with biopsy proven NASH. Saroglitazar has demonstrated good efficacy in animal models of NASH, along with associated biomarkers. It has reduced hepatic steatosis, ballooning, inflammation and fibrosis in liver. Recently completed phase 2 studies of Saroglitazar in patients with biopsy proven NASH patients has shown improvement in liver enzymes along with favourable effects on lipid and glycemic indices.

PUBLICATIONS:

POSTERS AND PRESENTATIONS :

Indication
indication
Current Status
phase III
Unmet Need
Anemia is a condition of having lower red blood cells or lower hemoglobin levels than is normal. Anemia is a serious medical condition linked to increased morbidity and mortality, and is commonly observed in patients with chronic kidney disease (CKD). Currently available agents for the treatment of anemia include injectable EPO stimulating agents (ESA’s) and intravenous iron supplements. The estimated global market for treatments for anemia related to CKD is $ 10 billion.
Publications & Posters
Outcomes of Desidustat Treatment in People with Anemia and Chronic Kidney Disease: A Phase 2 Study

Phase I Clinical Study of ZYAN1, A Novel Prolyl-Hydroxylase (PHD) Inhibitor to Evaluate the Safety, Tolerability, and Pharmacokinetics Following Oral Administration in Healthy Volunteers

Pharmacological Characterization of ZYAN1, a Novel Prolyl Hydroxylase Inhibitor for the Treatment of Anemia.

Influence of acute and chronic kidney failure in rats on the disposition and pharmacokinetics of ZYAN1, a novel prolyl hydroxylase inhibitor, for the treatment of chronic kidney disease-induced anemia.

A sensitive assay for ZYAN1 in human whole blood and urine utilizing positive LC-MS/MS electrospray ionization.

Pharmacological inhibition of prolyl hydroxylase protects against inflammation-induced anemia via efficient erythropoiesis and hepcidin downregulation.

Prolyl Hydroxylase Inhibitors: A Breakthrough in the Therapy of Anemia Associated with Chronic Diseases.

BIOLOGICS

TwinrabTM

Rabies and its Prevalence

  • Rabies is an acute viral encephalomyelitis of humans and other warm-blooded vertebrates1
  • It is caused by a member of the genus Lyssavirus of the Rhabdoviridae family1
  • Rabies is almost always fatal, as it has one of the highest case fatality rates of any infectious disease2
  • In more than 99% of all cases of human rabies, the virus is transmitted from dogs2
  • Globally around 59,000 human rabies deaths occur every year of which about one-third – 20,000, occurs in India alone3
  • Globally, around 6 million people undergo post exposure treatment (PET) of rabies every year4
  • In India, around 17.4 million animal bites occur every year, among which only 5 million rabies undergo post exposure prophylaxis (PEP) are provided3

Post-exposure Prophylaxis

All the cases of rabies exposure should be treated immediately for the prevention of of clinical symptoms and death.

Post-exposure prophylaxis consists of:

  • Wound treatment
  • Administration of rabies vaccines based on WHO recommendations
  • Administration of rabies immunoglobulin (if indicated)

Zydus Twinrab

Passive Immunisation6

  • Passive immunization should be administered just before or shortly after administration of the first dose of vaccine given in the post-exposure prophylaxis regimen
  • If it is not immediately available, passive immunization can be administered up until the seventh day after initiation of the primary series of post-exposure prophylaxis (with cell-culture or embryonated-egg rabies vaccine)
  • Passive immunization should be administered just before or shortly after administration of the first dose of vaccine given in the post-exposure prophylaxis regimen
  • If it is not immediately available, passive immunization can be administered up until the seventh day after initiation of the primary series of post-exposure prophylaxis (with cell-culture or embryonated-egg rabies vaccine)

Unmet Need – Requirement of Anti-Rabies Monoclonal Antibodies

Although two types of RIGs (HRIGs and ERIGs) are available, they have the following drawbacks:

1. HRIG:1

  • Risk of infections
  • Very expensive and available in limited quantities
  • High Volume of Administration

2. ERIG:1

  • Risk of zoonotic infections
  • Production largely discontinued due to animal protection groups
  • High Volume of Administration7

Other limitations of HRIG and ERIG7

  • 1. High cost – <2% utilization world-wide
  • 2. Cold storage
  • 3. Potential shortages
  • 4. Potential blood borne pathogens – Virus inactivation steps required

TwinrabTM - World‘s First Anti-Rabies Monoclonal Antibody Cocktail

TwinrabTM is a cocktail of two anti-rabies monoclonal antibodies, indicated for the post-exposure prophylaxis (PEP) of contact with a rabid or suspected rabid animal.

Twinrab™ is an equipotent mixture of two monoclonal antibodies i.e. docaravimab (MAb 62-71-3) and miromavimab (MAb M777-16-3) binding to two distinct sites on the Rabies virus.

The hybridomas were sourced from the following WHO collaborating centres through NIBSC, United Kingdom:

  • Docaravimab (MAb 62-71-3) – Centres for Disease Control and Prevention (CDC), Atlanta, USA
  • Miromavimab (MAb M777-16-3) – Animal Diseases Research Institute (ADRI), Nepean, Canada

The individual monoclonal antibodies present in the Twinrab™ cocktail mixture were found to neutralize in vitro, various rabies and rabies related viruses such as (CVS 11, SAD B19, PV, Kelev, European Fox, Dog Turkey, Dog Ethiopia, Dog India, Dog Mexico, Wolf Sarajevo, Bobcat-USA, EBLV 1, EBLV 2, East European fox, Polar fox, Dog Azerbaijan, Dog Nepal).

In various in vivo studies, the antibody cocktail was found to neutralize rabies virus isolates (CVS11, Mexican (2004), Thai (2006), Indian (2008) canine variants and Texas Fox 393 rabies virus). In still another in vivo study, the cocktail was also found to neutralize rabies virus isolates from Dog, Canine, Human, and Bovine sources isolated from southern parts of India.

TwinrabTM – Bridging the unmet needs

  • Twinrab™ is a novel drug for rabies post-exposure prophylaxis (PEP), approved by DCGI
  • Twinrab™ received orphan drug designation from US FDA in May 2019
  • Twinrab™ is World's First Novel Cocktail of 2 mAbs binding to two distinct epitopes, Docaravimab: Site I or III and Miromavimab: Site II
  • Cell lines in Twinrab™ have been sourced from WHO collaborating centres
  • Twinrab™ ensures more protective titre at the site of bite
  • Twinrab™ neutralizes a wide variety of viruses
  • There is no risk of zoonotic infection
  • There is no skin sensitivity test required
  • Twinrab™ has reduced amount of proteins and high purity that ensures less adverse events

Therapeutic indication

TwinrabTM is indicated for post exposure prophylaxis in individuals with suspected rabies exposure. Twinrab™ must always be used in combination with Rabies vaccine as part of post exposure prophylaxis in line with the recommendation of World Health Organization (WHO).

Dose and Mode of Administration

The recommended dose of TwinrabTM is 40 IU per kg of body weight. TwinrabTM is administered through infiltration around the wounds / scratches and by intramuscular injection.The entire Twinrab™ dose, or as much as anatomically possible (avoiding possible compartment syndrome), should be infiltrated carefully into or as close as possible to the wound(s) or exposure sites.

References:

VACCINES

The Vaccine Technology Centre (VTC) is the vaccine research centre of the Zydus Group. VTC has two state-of-the-art R & D Centers, one located in Catania, Italy and the other in Ahmedabad, in the western part of India. The Vaccine Technology Centre (VTC) has been developing vaccines for the basic vaccine programmes such as Diphtheria, Pertussis, Tetanus, Haemophilus Influenzae type B, Hepatitis B, Measles, Mumps, Rubella, Varicella, Influenza and Typhoid fever. In addition, VTC is developing new vaccines such as Human Papilloma Virus, Leishmaniasis, Malaria, Haemorrhagic Congo Fever, Ebola and Japanese Encephalitis.

Zydus has indigenously developed, manufactured and launched India's first Tetravalent Inactivated Influenza vaccine, VaxiFlu – 4. The vaccine provides protection from the four influenza viruses- H1N1, H3N2, Type B (Brisbane) and Type B (Phuket). . Zydus’ rabies vaccine manufacturing facility has received WHO pre-qualification, and is one of the largest rabies manufacturing facilities in India.

SCIENTIFIC ACTIVITIES

Scientific Activities

A global knowledge sharing forum on innovation - The Ramanbhai Foundation International Research Symposium

The Ramanbhai Foundation International Symposium is a biannual series of symposia devoted to the discussion of new trends in the pharmaceutical industry with a view to promoting scientific excellence in drug discovery and development.

Ramanbhai Foundation is named after a pathfinder, Late Mr. Ramanbhai B. Patel, who had dedicated his life to the quest of knowledge, as an academician, entrepreneur and a research scientist. He believed that new paths would surely open up if one has the creative will to discover it.

For more than a decade, the Ramanbhai Foundation (RBF) international symposium has been bringing together experts from both the academia and industry across the world to share their insights on the latest developments in pharmaceutical research. Internationally acclaimed researchers converge to address the various aspects related to New Drug Discovery - with a focus on diabetes, cardiometabolic diseases, NASH, inflammation and infectious diseases. The keynote addresses over the past few years have been delivered by the Nobel Laureates and Research Scientists of international acclaim. The symposium provides an insight into various aspects of drug discovery had an eminent panel of speakers and nearly 500 delegates from India and abroad participated in the symposium.

To know more about the RBF Symposium and/or to participate, please visit www.rbfsymposium.net

Collaborate

COLLABORATE

Zydus is constantly exploring opportunities in pharma research under these specific categories:

  • Collaborative research and development
  • In-licensing of technologies/NMEs
  • Out-licensing/co-development of Zydus’ drug candidates

If you wish to partner with us, you may reach out to -
Business Development
Zydus Research Centre
Sarkhej-Bavla N.H. No. 8A
Moraiya, Ahmedabad – 382210
Gujarat, India.

Phone: +91-2717-665555
Fax: +91-2717-665353