Xiling Lab Passing CFDI Verification, and Hinova Company Selected as Top 100 Innovative Seed Enterprises

Date:2021-12-28 Views:1720



       Recently, Chengdu Xiling Lab Pharmaceutical Co., Ltd. (hereinafter referred to as "Xiling Lab"), an enterprise in the park, successfully passed the development site verification organized by CFDI (Center for Food and Drug Inspection of NMPA) on two projects of iopromide (XL-445) and iodixanol (XL-619).


       This is the first development site audit conducted by CFDI on Xiling Lab, covering quality system management, prescription & process, sample trial production, packaging materials and containers for raw and subsidiary materials and direct-contact drugs, quality control, technology transfer, controls and reference preparations (including impurity control), stability research, data reliability, etc. During this period, the expert group put forward constructive suggestions on stability data evaluation, instrument calibration supervision. After verification, the expert group agreed that Xiling Lab meets the requirements of CFDI in terms of management system, quality standards and technical capacity, and can operate effectively.



       In China, it is a reliable expression of technical ability and quality management ability that an R&D center has passes the development site verification. The passing of the development site can be seen as Xiling Lab's R&D center already having the drug R&D system, quality management system and data management system that meet the requirements of CFDI, and also as the objective embodiment of the overall development quality management level of Xiling Lab's R&D Center, which will help to improve the social trust in the R&D center and enhance the market trust.


     "We are very happy to be inspected by the NMPA for the first time. This time, both XL-445 and XL-619 successfully passed the development site verification of CFDI, which is one of the important industrialization milestones since the establishment of Xiling Lab, meaning that we have a mature and reliable R&D team and laying a solid foundation for realizing the vision of "providing patients with safe, effective and accessible high-quality drugs!"


       —Dr. Huang Jinkun, General Manager of Xiling Lab.



       Recently, the list of "2021 Top 100 Chinese Pharmaceutical Innovative Enterprises" and "2021 Top 100 Chinese Pharmaceutical Innovative Seed Enterprises" was released at the "2021 China Healthcare Summit of Entrepreneurs, Scientists and Investors (hereinafter referred to as "CHSESI").



       Hinova was selected into the "2021 Top 100 Chinese Pharmaceutical Innovative Seed Enterprises".


       The conference was hosted by China Pharmaceutical Enterprises Association, China Medicinal Biotech Association, General Office of Central Committee of Chinese Peasants and Workers Democratic Party and Hangzhou Investment Promotion Bureau.


       "2021 Top 100 Chinese Pharmaceutical Innovative Seed Enterprises" is a list of high potential "seed" companies that represent innovative strength, which are selected from the three dimensions of innovation foundation, innovation process and innovation achievements based on hard data and the current situation of pharmaceutical innovation through model building, data collection and collation, with enterprises as the main body, four indexes, namely, the number of authorized patents, the total number of patents cited, the number of clinical trials and the number of innovative drugs approved and marketed, as the evaluation basis.


↓↓ Complete List ↓↓


         About Hinova

       Hinova is a global innovative drug enterprise focusing on cancer and metabolic diseases. With the mission of "creating good drugs to benefit the world", Hinova focuses on providing patients with safe, effective and affordable drugs. It is committed to R&D and production of innovative drugs that meet major clinical needs and have global interests.


       Since its establishment, with the strength of innovative technology, the company has set up four core technology platforms, namely, PROTAC targeted protein degradation technology platform, deuterated drug R&D platform, targeted drug discovery and validation platform and lead compound optimization and screening platform. Now it undertakes two major national "major new drug creation" science and technology projects and several provincial and municipal scientific research projects, with 10 products in development. The company's management team has rich experience in drug R&D, and most of its core members are from the world's top 500 well-known pharmaceutical enterprises.

       Hinova is carrying out two phase III clinical trials for the treatment of castration-resistant prostate cancer in China and around the world and phase II / III clinical trials for the treatment of COVID-19 in Brazil with HC-1119 in the existing product pipeline; the phase II clinical trials of HP501 for the treatment of hyperuricemia/gout has been completed; the phase I clinical trial of HP558, which has potential therapeutic effect on gastrointestinal tumors, has been completed in Europe, and the application for phase II clinical trial has been approved by NMPA; and HP518, an oral PROTAC drug that acts on AR has obtained ethical approval in Australia. At present, Hinova has received investment from many well-known institutions, with a total amount of about RMB 1.4 billion.


Source: Chengdu Xiling Lab and Hinova


  • Phase One

    Tel:028-85975146

    Add:No. 88, Keyuan South Road, High-tech Zone, Chengdu

  • Phase Two

    Tel:028-85326166

    Add:No. 2222, Xinchuan Road, High-tech Zone, Chengdu

  • Phase Three

    Tel:028-58976074

    Add:No. 2222, Xinchuan Road, High-tech Zone, Chengdu

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