Yunnan Hande Bio-Tech Co.,Ltd.is a Paclitaxel API Factory.At present,a production line that has been put into operation produces 500kg of Natural Paclitaxel APIs every year,making it the largest paclitaxel API manufacturer in Yunnan.In addition to domestic orders,Hande Bio-Tech has 16 stable foreign customers and 42 foreign customers who provide samples for testing and testing.
Leading the Paclitaxel API Industry
On the wall of the administrative office area of Hande Bio-Tech,there are six invention patents and many honorary medals.
“100%assurance of the quality of Paclitaxel API per gram is the key for the company to win the market and customers.”Zixin Zou,head of the preliminary processing and production department of Hande Bio-Tech,said.
In the testing center,several technicians are busy.They are debugging the testing equipment,preparing the Paclitaxel API extraction stock solution,and determining the water content…To produce a qualified paclitaxel API,many procedures need to be followed,and each step has strict quality management system index control.
How to increase the content of Paclitaxel(Taxol)from the initial 0.3‰to 99%is a professional skill.This testing center is constructed in strict accordance with national standards,covering all testing items such as liquid phase,gas phase,metal element,infrared,microorganism,moisture determination,stability inspection,etc.The testing center adopts fully imported testing equipment and IT system with data integrity;The totally closed separation and purification production line and the sterile clean workshop for the purification of finished products are full of modern science and technology.
In 1996,taking aim at the Paclitaxel API industry,Hande Bio-Tech established a Paclitaxel API production plant in Kunming Jinding Science and Technology Park to carry out the R&D and production of natural plant extracted Paclitaxel API,becoming the first enterprise engaged in this industry in Yunnan.In 1999,Hande Bio-Tech products entered the European and American markets.From 30kg,50kg,70kg in the past year to 500kg in the present,this production line has passed the on-site inspection certified by the United States,Europe and China,as well as the irregular on-site audit and visit of customers,and has become an independent manufacturer of paclitaxel,an internationally recognized anticancer API extracted from plants.
Paclitaxel(Taxol)is an anticancer API extracted from the bark of short leaf yew or artificially planted yew branches and leaves.It has unique curative effects on ovarian cancer,breast cancer,lung cancer,colorectal cancer,melanoma,head and neck cancer,lymphoma,brain tumor,etc.Chemical APIs have a long period of validation,filing and approval.After years of international market operation and certification by regulatory agencies around the world,Hande Bio-Tech has an advantageous background and experience among competitors in the domestic phytochemical API industry.
For 26 years,the‘low-key’Hande Bio-Tech Company has always said that it is a”small pharmaceutical factory”,but it leads the Paclitaxel API industry in Yunnan.
The API of Cepharanthine is being developed
In 2018,Hande Bio-Tech established a new production base in Anning and pressed the start key of a new chapter in the development of Yunnan Paclitaxel API industry.
After relocation,the production workshop area has increased from 1500 square meters to 4500 square meters.Next,after the semi-synthetic Paclitaxel API production line with an annual output of 800 kg is completed,the annual output value will reach 300 million yuan.
At present,54 domestic customers,16 foreign customers and 42 foreign customers who provide samples for testing and trialing have achieved stable supply of Paclitaxel APIs produced by Hande Bio-Tech.At present,Hande Bio-Tech is developing the API of Cepharanthine,and the exclusive human drug ecdysterone project with French customers is also in progress.
This year,Kunming has optimized and adjusted the biopharmaceutical industrial chain as one of the eight industrial chains focused on building.Chemical raw materials and generic drugs are key areas of the biomedical industry chain.Zixin Zou said that when the time is ripe,Hande Bio-Tech will deepen the development of more high-end characteristic APIs of anti-tumor series,and expand and strengthen the biomedical industry chain of the API industry.
Now,Hande Bio-Tech has become an internationally famous brand recognized by Yunnan Province as a high-tech enterprise,a small and medium-sized technology-based enterprise,an enterprise technology center,and China Quality Certification and Supervision Center.In 2019,it was included in the key project library of the”Three year Multiplying Enterprise Listing Plan of Yunnan Province”by the Local Financial Supervision and Administration Bureau of Yunnan Province.
Hande Bio-Tech plans to build the second phase development project,and is committed to becoming the largest first-class production base of Paclitaxel API in China.It will spare no effort to promote the development of biological medicine and mass health industry in the province,and improve the health and well-being of the people.
(Written by Heqing Huang,reporter of Kunming Daily)
Post time: Oct-31-2022