Recently, the transformation of scientific and technological achievements in the biomedical industry in Qiantang (New) District ushered in the "first order of the new year" - KL003 cell injection independently developed by Kanglin Biotechnology (Hangzhou)**hereinafter referred to as "Kanglin Biotechnology") located in Hangzhou Medical Port has successfully obtained the implied permission for clinical trials from the National Medical Products Administration (NMPA) of China.
Kanglin Biotech is a company that develops genetically innovative drugs, and its KL003 cell injection is a genetically modified autologous hematopoietic stem cell product, which is clinically used for thalassemia or transfusion-dependent type in children. At present, KL003 cell injection has completed the construction and verification of the commercial cell production workshop. With the self-developed high-efficiency suspension lentiviral vector expression process, the production cost of KL003 will be greatly reduced, and it is expected to be as low as a few tenths of that of the world's leading pharmaceutical companies.
To make an enterprise bigger and stronger, in addition to its own skills, the help of the best is also indispensable. Wu Haoquan, founder of Kanglin Biology, said, "Clinical resources are very scarce resources for our current new drug development, and under the recommendation of Hangzhou Medical Port, we hit it off with the First Hospital of Zhejiang University, and we are expected to carry out in-depth cooperation in the clinical research of functional drugs such as hemophilia and thalassemia in the later stage, which solves one of our major problems." ”
From the laboratory to clinical trials, innovative drugs are inseparable from the escort of all parties. As one of the "five leading" industries in Qiantang, in order to promote the industrialization of scientific and technological achievements and promote the high-quality development of the biomedical industry, Qiantang has carried out a special micro-reform of "one of the things" in the R&D and innovation of the biomedical industry.
Focusing on the four key issues of pharmaceutical enterprise professionals, adaptation venues, public service platforms, and import of special biological products, Qiantang integrates first-class, market, and social resources to form a "first-class" service chain, providing biopharmaceutical enterprises with 21 basic government services such as drug purchase license and purchase review, and superimposing 18 high-relevance value-added services such as talent recruitment, clinical trial docking, and registration and approval.
At the same time, Qiantang has also built a service complex for the transformation of scientific and technological achievements, established a full life cycle management system for doctors to enter the enterprise, set up a business ** and a service window, and iterated the content of "one type of thing" according to the suggestions of the enterprise.