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    NMPA Grants Priority Review to NDA for Glycerol Phenylbutyrate oral liquid

    August 23, 2022

    [Beijing, China, August 23, 2022] Mr. Jack Wang, founder, chairman and CEO of Hong Kong Winhealth Pharma Group ("Winhealth Pharma") announced today that the National Medical Products Administration (NMPA) has accepted and granted Priority Review for the New Drug Application (NDA) of “glycerol phenylbutyrate oral liquid” (a new drug product for rare disease) which is pre-marketing clinical study waiver in China. This is of great significance for rapid access to new drugs in patients with urea cycle disorders (UCDs) in China. As an innovative biopharmaceutical company, Winhealth Pharma has always adhered to its original intention of "Patient Comes First". The acceptance of NDA regarding glycerol phenylbutyrate oral liquid reflects our commitment and practice in providing innovative therapies for patients with rare diseases and other unmet medical needs

    The proposed indication for glycerol phenylbutyrate oral liquid in China is the chronic management of patients with UCDs that cannot be managed with protein restriction and/or amino acid supplementation alone. Urea cycle disorders (UCDs) are rare inherited metabolic disorders characterized by hyperammonemia that arise in either the neonatal period or later. The clinical manifestations include changes in the level of consciousness similar to encephalitis or drug intoxication, acute encephalopathy, epilepsy, lethargy, and mental disorders. Hyperammonemia may lead to severe neurocognitive impairment, coma, and even death.

    In December 2020, Winhealth Pharma signed an agreement with Immedica Pharma AB, under which Winhealth Pharma was granted exclusive commercialization rights for glycerol phenylbutyrate oral liquid in Greater China, South Korea, Singapore, Vietnam, Indonesia, Malaysia, the Philippines and Thailand.

    About Winhealth Pharma

    Hong Kong Winhealth Pharma Group ("Winhealth Pharma") is a China-based, global innovative biomedical company founded in 2006, providing novel breakthrough therapies to patients with rare diseases and other unmet medical needs. The Group has established long-term strategic partnership with dozens of world-leading biotechnology companies. It has built a unique, balanced and diversified portfolio with numerous orphan drugs and specialty products at commercial and late clinical stages, and will continuously look to bring in more innovative therapies from the globe.

    About Immedica AB

    Immedica is a fast-growing private niche pharma group with headquarter in Stockholm, Sweden and commercial coverage across Europe and the Middle East. Immedica has significant know-how and experience in commercialization of niche/specialty care products across Europe and the Middle East, and the company’s management team has an outstanding track record of operating niche pharma products internationally. Immedica has capabilities to provide optimal access of specialty care medicines to patients with significant medical needs, including key areas such as regulatory affairs, pharmacovigilance, medical affairs, pricing & reimbursement, quality, and product distribution. More information is available at www.immedica.com.

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