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Sihuan Pharmaceutical's Gabapentin Capsules was Granted Drug Production Approval, the Third Company Obtained Approval in China

HONG KONG, Oct. 22, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (the "Company'' or ''Sihuan Pharmaceutical'', together with its subsidiaries, the ''Group''; HKEX stock code: 0460) is pleased to announce that the National Medical Products Administration has granted drug production approval for the Group's gabapentin capsules (the ''Product''). Sihuan Pharmaceutical is the third company that obtained production approval for the Product in China.

The Product is a Category B drug under the Drugs Catalogue for the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance, is used to treat Postherpetic Neuralgia and Epilepsy. It can also be used for the adjuvant treatment of partial seizures in children aged between 3 to 12 years old.

Gabapentin capsules demonstrate fast absorption through oral administration, good drug tolerance, minimal toxicity and side effects and excellent therapeutic effect. When consumed, it is not subject to metabolism, plasma protein binding and liver enzyme induction. The Product is able to penetrate the blood-brain barrier of a human brain with low possibility of interacting with other anti-epileptic drugs, and it can be used alone to treat general epilepsy or as a superimposed medication for refractory epilepsy. Compared with similar products being applied currently, the Product is particularly effective as a superimposed medication for refractory epilepsy. With its unique advantages in neuropathic pain, gabapentin capsules have become a first-line drug for the treatment of neuropathic pain.

Epilepsy is a common chronic neurological disease second only to stroke. It can occur in people of all age, region and race, with children and the elderly demographic groups with peak incidences. There are no less than nine million people suffer from epilepsy in China. As the patient population gradually increases, the market size of anti-epileptic drugs will also expand rapidly. In 2018, the market size of terminal chemical anti-epileptic drugs in China's public medical institutions was RMB4.9 billion. In 2019, gabapentin ranked seventh in overall ranking of terminal chemical anti-epileptic drugs used in China's public medical institutions with sales amounted to RMB203.0 million, accounting for approximately 4.14% of the market share. The low rate of medical treatment for patients among the epilepsy in China offers a huge potential for future growth in the anti-epilepsy drug market.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group commented, "As a medication used to treat neurological diseases, our gabapentin capsules will create synergy with other drugs of the Group in the relevant treatment fields, including oxcarbazepine tablet already on the market; midazolam oromucosal solution, rivastigmine hydrogen tartrate capsule, levetiracetam tablets which were recently granted approval and will soon be launched, as well as eslicarbazepine tablets and lacosamide tablet which are undergoing the approval application process. Sihuan Pharmaceutical continues to strengthen its leading market position by providing patients with a wider range and better quality treatment options."

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical Holdings Group Ltd. (the "Company'' or ''Sihuan Pharmaceutical"), together with its subsidiaries (the "Group") is a pharmaceutical group with integrated research and development ("R&D"), production and marketing and sales capabilities. It is one of the largest suppliers of cardio-cerebral vascular ("CCV") prescription drugs in China. Sihuan Pharmaceutical has an excellent and professional marketing model, a nationwide distribution network, a diversified product portfolio with great market potential, as well as strong R&D capability. The Group continues to increase investment in R&D every year. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has a R&D platform with over 1,000 researchers conducting more than 110 pharmaceutical research projects. More than 300 patents on innovative drugs have been granted and over 80 of them are overseas patent. The Group's current pipeline projects cover key therapeutic areas including diabetes, oncology, anti-infectives and non-alcoholic steatohepatitis, etc.

For more information about SihuanPharmaceutical, please visit the company website

SOURCE Sihuan Pharmaceutical Holdings Group Ltd.

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Last Updated: 22-Oct-2020