August 2, 2023, Shenzhen Beimei Pharmaceutical Co., Ltd. (hereinafter referred to as "Beimei Pharmaceuticals") in collaboration with Hetero Labs Limited is pleased to announce that our imported drug formulation "Lacosamide Oral Solution (Trade Name: 乐美定®)" has successfully received approval from the NMPA, the National Medical Products Administration, for the adjunctive treatment of partial-onset seizures in patients aged 4 years and older.

Lacosamide is a third-generation antiepileptic drug and is recommended as a first-line treatment for focal onset seizures. It possesses a unique mechanism of action—selectively targeting the slow inactivation sodium channels, resulting in a stronger and more prolonged closure of these channels. This provides an effective antiepileptic effect, bringing a new treatment option for patients with partial onset seizures.

Lacosamide is the second largest species in the global antiepileptic drug market. In China, the lacosamide formulation market is increasing exponentially year by year, with sample hospital sales exceeding 53.3 million RMB in 2021 and 114 million RMB in 2022. The domestic market of Lacosamide has huge upside.

As an original import with international high quality certified by the FDA, 乐美定® comes equipped with a measuring cup and dosing device, providing more precise dosing especially for pediatric patients, thus enhancing medication safety. Additionally, its strawberry flavor is designed to improve the compliance of pediatric patients.

This product is the first antiepileptic drug approved for Beimei Pharmaceuticals and serves as a significant addition to the company's CNS product line, especially following the approval of our self-developed atomoxetine oral solution. With numerous pediatric neurologic disorders that can severely impact both physical and mental health, the CNS field remains one of Beimei’s primary focus pipelines. We have already laid out a number of products in the CNS field, which will be filed and approved one after another, offering more treatment choices for suffering children.

About Hetero

Founded in 1993, Hetero is India's largest private pharmaceutical company, a leading generic drug manufacturer in India, and one of the world's largest producers of antiretroviral drugs for HIV/AIDS treatment. Committed to the development, production, and marketing of high-quality chemical and biological drugs across various therapeutic areas.

After 30 years of excellence, Hetero has become one of the world's largest producers of ARV APIs & FDFs, with more than 300 APIs and more than 200 FDFs. The company has a network of operations in more than 140 countries and employs more than 22,000 people worldwide. It is globally renowned for its strengths in the development, manufacturing and commercialization of a wide range of products.

About Shenzhen Beimei Pharmaceutical Co., Ltd.

Headquartered in Shenzhen, China, Beimei Pharmaceuticals specializes in pediatric chemical drugs, integrating R&D, global licensing, manufacture, and marketing. With a portfolio covering more than 30 pediatric products, including three innovative drugs with global rights and proprietary intellectual property, we addresses a broad range of areas, such as respiratory, anti-infective (antibacterial), neurology, digestive, endocrine, and otolaryngology.

Beimei has established long-term partnerships with leading pharmaceutical companies including Hetero, Cipla, EMP, Deva, Dr. Reddy's, LTS, MedPharma, Synthon, and NTC. In 2021, Beimei successfully raised over 100 million RMB in Series A and Series B/B+ funding rounds, further accelerating our missions to offer precise dosing, palatable, and high-quality standard products for pediatric patients in China, aiming to pioneer and innovate in the pediatric medication in China.

For further information, please visit http://www.beimeiyaoye.com.