"Shilpa House", # 12-6-214/A-1, Hyderabad Road, Raichur - 584 135, Karnataka, India
Tel: +91-8532-238704, Fax: +91-8532-238876 Email:info@vbshilpa.com, Web: www.vbshilpa.com CIN: L85110KA1987PLC008739
Date: 25 April 2022 | |
To | To |
Corporate Relationship Department | National Stock Exchange of India Limited |
BSE Limited, | Exchange Plaza, 5th Floor, |
1st Floor, Rotunda Building, | Plot No.C/1, G Block |
P.J. Towers, Dalal Street, | Bandra Kurla Complex, Bandra (E) |
Mumbai - 400 001 | Mumbai - 400 051. |
Sub: Shilpa Medicare Limited (SML) receives NoC from RCGM, Dept. of Biotechnology for its Biosimilar Aflibercept
Ref: Intimation U/R 30 of the SEBI (Listing Obligation and Disclosure Requirements) Regulations 2015
Scrip Code:530549/ Stock Symbol: SHILPAMED
Dear Sir/Ma'am,
This is to inform you that the Company, via its wholly owned subsidiary, Shilpa Biologicals Private Limited (SBPL), has received a NoC from RCGM, Dept of Biotechnology to approach the DCGI to conduct Clinical studies for its Biosimilar Aflibercept - a first from an Indian company. The product is a biosimilar version of EYLEA® of Regeneron for which currently there is no other biosimilar version on the Indian market.
The Company intends to now approach the DCGI to conduct local and global Human Clinical studies to cater to the burgeoning Wet Age-Related Macular Degeneration (wAMD), Diabetic Retinopathy, Diabetic Macular Edema (DME) and Macular Edema following Retinal Vein Occlusion markets in India and across the globe. India has amongst the highest incidences of the above indications and the market is under-catered to by current therapies.
The Drug had global sales or appx $9.38 billion in 2021 and is amongst the top ten drugs today, growing at 19% pa. The biosimilar product at SBPL is part funded through the BIRAC grants and developed at its integrated Dharwad facility. The Company intends to ensure global accessibility to the product via differentiated pricing and formulations/delivery mechanisms.
"Shilpa House", # 12-6-214/A-1, Hyderabad Road, Raichur - 584 135, Karnataka, India
Tel: +91-8532-238704, Fax: +91-8532-238876 Email:info@vbshilpa.com, Web: www.vbshilpa.com CIN: L85110KA1987PLC008739
Biosimilar Aflibercept is the second biosimilar product from SML that has entered the clinical trial phase after Biosimilar Adalimumab.
SML views Biologics as a strategic growth area and has made significant investments in setting up a High end, Flexible Biologics facility in SBPL, Dharwad to cater to the requirements of the fast-growing biologics field, that include the DNA vaccine, adenoviral, subunit vaccines, Monoclonal antibodies & fusion proteins.
The Exchange is requested to take the same on record and disseminate the information to stakeholders of the Company.
Thanking you,
Yours Sincerely,
For Shilpa Medicare Limited
Vishnukant Bhutada
Managing Director
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Shilpa Medicare Ltd. published this content on 25 April 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 April 2022 07:48:02 UTC.