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Group Real-Time Dynamics And Cutting-Edge Information In The Field Of One Health
Jiankangyuan's 6 billion anti-infective drug is the first to pass the review, and the orphan drug wins the first follow-up, which is good news for patients.
Published Time：
2020-11-13
Meropenem was originally developed jointly by Sumitomo Pharmaceuticals Co., Ltd. of Japan and a British pharmaceutical company. As a leading product among carbapenem antibiotics, the medical community generally believes that meropenem is one of the few broad-spectrum antibiotics that can treat various infectious diseases. Because of this, the drug is of extraordinary significance to the large population of patients in China suffering from pneumonia, urinary tract infections, gynecological infections, skin and soft tissue infections, meningitis, and sepsis.
On October 24, Joincare Pharmaceutical Group Industry Co., Ltd. (hereinafter referred to as "Health Yuan") issued two consecutive announcements stating that its wholly-owned subsidiary, Shenzhen Haibin Pharmaceutical, has obtained approval for its consistent evaluation through a supplementary application for its Meropenem for Injection, making it the first domestic company to pass the evaluation for this product. Data from MiNet shows that in 2019, the terminal sales of Meropenem injection in China's public medical institutions exceeded 6 billion yuan; in the first half of 2020, sales exceeded 2.5 billion yuan. Among them, Sumitomo of Japan had the largest market share, nearly 40%; Shenzhen Haibin Pharmaceutical accounted for over 20%. In addition, its holding subsidiary, Lizhu Pharmaceutical Group, under its wholly-owned subsidiary Lizhu Pharmaceutical Factory, independently developed and obtained approval for the listing of Dantrolene Sodium for Injection, securing the first domestic imitation.
Masterfully Crafted! First to Pass Evaluation for 6 Billion Anti-Infection Injection
Basic Information on the Drug
Data shows that this product is suitable for adults and children with infections caused by single or multiple bacteria sensitive to meropenem: pneumonia (including hospital-acquired pneumonia), urinary tract infections, gynecological infections (such as endometritis and pelvic inflammatory disease), skin and soft tissue infections, meningitis, and sepsis. For empirical treatment of adult patients with neutropenia and fever, this product can be used alone or in combination with antiviral or antifungal drugs. This product can be used alone or in combination with other antimicrobial agents to treat multiple infections. Currently, there is no experience using this product for infants with neutropenia or primary or secondary immunodeficiency.
Recent Sales of Meropenem Injection in China's Public Medical Institutions (Unit: 100 million yuan)
Source: Competitive Landscape of China's Public Medical Institutions
Data from MiNet shows that in 2019, the terminal sales of Meropenem injection in China's public medical institutions (including urban public hospitals, county-level public hospitals, urban community centers, and township health centers) exceeded 6 billion yuan; in the first half of 2020, sales exceeded 2.5 billion yuan. Among them, Sumitomo of Japan had the largest market share, nearly 40%; Shenzhen Haibin Pharmaceutical accounted for over 20%, followed by Shiyao Ouyi Pharmaceutical and Hanhui Pharmaceutical.
To date, a total of 11 companies in China hold registration certificates for Meropenem for Injection. In terms of consistent evaluation, Shenzhen Haibin Pharmaceutical is the first domestic company to pass the consistent evaluation for Meropenem for Injection. As of the announcement date, the cumulative direct R&D investment for this product's consistent evaluation is approximately 15.2105 million yuan. In addition, five other companies, including Chongqing Shenghua Xi Pharmaceutical and Shenzhen Huayao Southern Pharmaceutical, have supplementary applications under review and approval (at the CDE).
Rising to the Challenge! First Domestic Imitation of Dantrolene Sodium for Injection, a Rare Disease Drug
Basic Information on the Drug
Dantrolene Sodium for Injection, after 10 years of research and development, is a generic drug independently developed by Lizhu Pharmaceutical Factory. Its indications are for the prevention and treatment of malignant hyperthermia. Malignant hyperthermia is a rare disease, a familial muscle disease mainly triggered by volatile inhaled anesthetics and depolarizing muscle relaxants - succinylcholine, resulting in abnormally high skeletal muscle metabolism. Without specific treatment drugs, general clinical cooling measures are difficult to control the increase in body temperature, which can ultimately lead to patient death. This product is the first domestic imitation, and as of the announcement date, the cumulative direct R&D investment for Dantrolene Sodium for Injection is approximately 17.2234 million yuan.
Data shows that the original research product of Dantrolene Sodium for Injection is Dantrium® by Par Sterile Products LLC of the United States. This drug was first approved for marketing in the United States in 1979, used in all age groups to control the explosive metabolic hyperactivity manifested as malignant hyperthermia crisis, accompanied by appropriate supportive therapy. As of the announcement date, only Lizhu Pharmaceutical Factory has obtained the registration certificate for Dantrolene Sodium for Injection in China, and no other manufacturers have applied.
This time, Health Yuan's first-to-market evaluation of a 6 billion anti-infection drug and its first domestic imitation of a rare disease drug mark the transition of Chinese pharmaceutical companies, represented by Health Yuan, from the "construction period" of products to the "peak harvest period." Health Yuan has always adhered to the spirit of craftsmanship, constantly striving for excellence, and producing high-quality medicines that are needed and affordable for the Chinese people.
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