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The hope of "life", the future of "growth" - Lizhu's restructured HCG approved for market launch
Release time:
2021-04-16
On the evening of April 15, 2021, Zhuhai Lizhu Biopharmaceutical Co., Ltd. received the "Drug Registration Certificate" issued by the National Medical Products Administration. The injectable recombinant human chorionic gonadotropin (recombinant HCG) successfully passed the "Drug Administration Law of the People's Republic of China" and relevant regulations, and was granted a drug registration certificate for production and market sales.
The approval of this product is a blessing for patients and also good news for the research and innovation in the domestic assisted reproductive field.
According to relevant statistics, in recent years, the incidence of infertility in China has been increasing year by year. As of 2019, the infertility rate was about 16.40%. With the continuous decrease of the demographic dividend in our country, effective treatment of infertility has become an urgent demand of the times. The continuous expansion of market demand and the continuous maturity and progress of assisted reproductive technology will lead to a constant rise in the demand for the assisted reproductive market.
Lizhu has been in a leading position in the assisted reproductive field for many years. The recombinant HCG approved for market is the first product in China and the second in the world. It is also the first biopharmaceutical product approved for market since the establishment of Lizhu Biopharmaceutical Co., Ltd. in 2010. It breaks the long-standing technological monopoly of foreign countries, its technological content is at the leading level in the industry, and it contributes to alleviating the current shortage of domestic urine-derived HCG, supporting the national advocacy for independent research and innovation.
The product has been solidly developed at every stage: during the production approval process, the project team prepared all materials and data thoroughly and conducted research and production according to ICH guidelines. The CDE holds face-to-face Pre-NDA meetings to discuss the reported products, and any issues that require additional research must be addressed before formal production approval. However, the research materials and reports from this project team received unanimous recognition from experts—this product's research and production can truly be executed according to ICHQ8 principles, which is rare in the country. They immediately received a written response that formal production approval could be submitted, saving at least 3-6 months of time.
Lizhu Biopharmaceutical Co., Ltd. has established a typical demonstration base for antibody drug industrialization in Guangdong Province, with a building area of nearly 20,000 square meters. It has established an integrated technical platform covering antibody humanization, cell line screening, large-scale cell culture, purification, formulation, analysis and testing, and quality control, meeting the conditions for research and development and industrialization of antibody drugs. Currently, several research projects are at different clinical stages, and in the coming years, products will be continuously launched, practicing Lizhu's mission of "Patient Quality of Life First" through research and innovation.
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