Kashiv BioSciences, LLC (“Kashiv” or the “Company”) today announced that it has entered into a licensing and supply agreement with CRISTÁLIA, one of the leading pharmaceutical companies in Brazil, for the commercialization of ADL-018 / bOmalizumab, a proposed biosimilar to Xolair^®, in Latin America (LATAM). In 2024, IQVIA recorded approximately $5.0 billion in global sales, with approximately $140 million contributed by the LATAM region.

Under the terms of the agreement, Kashiv BioSciences is responsible for the development of the product within the agreed territories. CRISTÁLIA will be responsible for the licensing, distribution, and commercialization of ADL-018 in the LATAM region.

Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences said, “CRISTÁLIA is an ideal partner to commercialize ADL-018 across Latin America, supporting Kashiv’s mission to expand its biosimilar portfolio and increase global access. We look forward to CRISTÁLIA bringing our omalizumab biosimilar to patients in this important region.”

“We are thrilled to have entered a partnership with Kashiv for the licensing of Omalizumab biosimilars in the LATAM region,” Dr. Ogari Castro Pacheco, Chairman of CRISTÁLIA stated, “CRISTÁLIA is confident that this molecule will be a key asset to our biosimilars portfolio and as part of our company strategy to expand patient access to high quality, affordable treatments in the future.”

About ADL-018:

ADL-018 is a proposed Xolair^® biosimilar. Omalizumab is a humanized monoclonal antibody that targets free immunoglobulinE (IgE). Xolair® is indicated for the treatment of Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU), severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy. ADL-018 is an investigational product and has not received regulatory approval in any country. Biosimilarity has not been established by regulatory authorities and is not claimed.

Xolair® is a registered trademark of Genentech, Inc. and Novartis AG.

About Kashiv BioSciences

Kashiv BioSciences, LLC is a vertically integrated biopharmaceutical company with numerous commercial and advanced clinical-stage assets and is among the few U.S.-based companies to both manufacture and receive marketing authorization for multiple biosimilars. Kashiv BioSciences, LLC in the USA, and its subsidiaries in India (together “Kashiv BioSciences”) operate together with a robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

For more information, please visit https://www.kashivbiosciences.com/

About CRISTÁLIA

CRISTÁLIA is a private owned Brazilian biopharma company, with 53 years of operation and a broad footprint across the main Latin America markets. CRISTÁLIA is dedicated to the discovery, development, manufacturing, and commercialization of life-saving treatments to patients with severe, life-threatening diseases or injuries.

In addition to the biopharmaceutical business, CRISTÁLIA also ranks between the biggest API manufacturers in Latin America, with state-of-the-art facilities dedicated to the manufacturing of synthetic, oncologic and biotech active ingredients.

CRISTÁLIA is headquartered in Campinas (Brazil).

For more information, please visit Cristália - Indústria Farmacêutica

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Dr. Sandeep Athalye, Chief Executive Officer at Kashiv BioSciences said, “CRISTÁLIA is an ideal partner to commercialize ADL-018 across Latin America, supporting Kashiv’s mission to expand its biosimilar portfolio and increase global access."