2022-07-14
Recently, Beimei pharmaceutical co., Ltd (hereinafter referred to as the “Beimei”) and Aosaikang Pharmaceutical Co., Ltd (hereinafter referred to as the “Aosaikang”) have made a cooperative promotion authorization agreement on Esomeprazole magnesium delayed release oral suspension (hereinafter referred to as the "Product") in the specified regions and provinces across the country (hereinafter referred to as "the Agreement").
According to the Agreement, Aosaikang obtained the cooperative promotion rights of the Product in specified regions and provinces in China. The cooperative Product was licensed-in by Beimei in 2020. Beimei has its domestic registration and commercialization rights, as the first company to apply this product for launch in China in April 2021. The collaborative Product is developed and manufactured by Cipla, India. In addition, it was approved for marketing by the US FDA in March 2020, which is the first generic Esomeprazole magnesium delayed release oral suspension approved in the US, with three strengths of 10mg, 20mg and 40mg.
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Basic information of cooperative product
► Esomeprazole magnesium delayed release oral suspension is mainly used for the treatment of erosive esophagitis (EE), gastroesophageal reflux disease (GERD), risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer, eradication of Helicobacter pylori in combination with appropriate antimicrobial agents and pathological hypersecretory conditions including Zollinger-Ellison Syndrome in adults, etc.
► Compared with ordinary dosage forms, enteric delayed release dry suspension is convenient for pediatric patients and patients with dysphagia. At present, no enteric delayed release dry suspension has been approved for marketing in China. Esomeprazole magnesium delayed release oral suspension is the only PPI drug in enteric delayed release dry suspension dosage form that approved for clinical use in pediatric patients. Esomeprazole magnesium delayed release oral suspension is in the national “Second Pediatric Drug List Encouraged For Research And Development To Apply”, and is one of the pediatric drugs in urgent clinical need that have not been registered and launched in the mainland China.
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The market situation of drugs in the same kind
► Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. Compared with other PPI, esomeprazole can inhibit gastric acid more quickly, relieve symptoms more quickly, and exert effects for a longer time. Esomeprazole is a weakly alkaline drug that is unstable to acids, so that its enteric-soluable form can protect the drug from damage by gastric acid, allowing it to be better absorbed from the small intestine into the bloodstream and improving its bioavailability.
► According to IQVIA, the sales of traditional PPI bidding prices reached 20.11 billion Yuan RMB in 2021, of which the oral PPI market exceeded 10 billion Yuan RMB. The sales of Esomeprazole magnesium delayed release oral suspension exceeded 1 billion Yuan RMB in the U.S. in 2021. The cooperative Product has been approved for launch in the U.S. in 2020, and the sales has exceeded 30 million USD (over 200 million Yuan RMB) in 2021.
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Jiangsu Aosaikang Pharmaceutical Co., Ltd.
Jiangsu Aosaikang Pharmaceutical Co., Ltd. (ASK Pharm) is a wholly-owned subsidiary of Beijing Aosaikang Pharmaceutical Co., Ltd. (Stock code: 002755.SZ), a company listed on the main board of the Shenzhen Stock Exchange, with two technological research and development platforms, namely chemical and biological drugs. It is a comprehensive high-tech enterprise integrating R&D, production and sales. ASK Pharm’s products cover the fields of digestion, anti-tumor, chronic ailment, anti-drug-resistant infection and other treatment, and have a very high brand influence in the market segment. For many consecutive years, he was awarded the honorary title of "Best Industrial Enterprise of China Pharmaceutical R&D Product Line" and "National Innovative Pharmaceutical Enterprise."
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Shenzhen Beimei Pharmaceutical Co., Ltd.
Beimei pharmaceutical focuses on the field of pediatric prescription medicines, headquartered in Shenzhen, China, incorporating R&D, global licensing, manufacture, marketing and distribution, and has more than 30 pediatric products in its portfolio and pipeline, covering the respiratory system, anti-infection (antibacterial), nervous system, digestive system, endocrinology, ENT and other fields. Beimei Pharmaceutical has established long-term partnerships with companies such as Hetero, Cipla, EMP, Deva, Dr Reddy, LTS, MedPharma, Synthon, NTC, etc., and completed over 100 million RMB series A and series B/B+ financing, which will further support Beimei to be a pioneer in Chinese pediatric field to meet the clinically unmet demand and provide Chinese pediatric patients with products that are with high-quality, good tasting and can be accurately administrated.