In July 2023, the Anhui Provincial Economy and Information Department and Anqing Municipal Bureau of Economy and Information announced the "2023 List of Intelligent Factories and Digital Workshops in Anhui Province" and the "2023 List of Intelligent Factories and Digital Workshops in the Municipality", respectively. Anqing Municipal Bureau of Economy and Information awarded the honors on the spot in November.
Passed FDA Inspection: a FDA cGMP field inspection was conducted on Anhui Poly Pharm. Co., Ltd (hereinafter referred to as "Anhui Poly"), a wholly owned subsidiary of Hainan Poly Pharm. Co., Ltd (stock code: 300630), from August 21, 2023 to August 25, 2023.
Following the approval of Dobutamine Hydrochloride Injection with dual specifications (20ml:250mg and 40ml:500mg), Poly Pharm.. has recently received the registration approval for consistency evaluation of Dobutamine Hydrochloride Injection (1.6ml:20mg) issued by the National Medical products Administration (NMPA). The approval of multiple specifications of the product can meet different clinical needs for medication, which is conducive to enhancing the market competitiveness of the drug, and will have a positive impact on the company's operating results.
Boron Neutron Capture Therapy (BNCT), as a kind of binary targeted therapy, the biggest difference lies in the use of boron drugs that can target tumors, relying on the difference in boron drug absorption between tumors and normal tissues to achieve precise targeting and killing at the cellular level. Therefore, boron drugs play an important role in BNCT therapy, and the most critical component of boron drugs is the boron 10 isotope it carries. Natural boron contains both boron 10 and boron 11 isotopes in the ratio of 2:8, of which only boron 10 is able to capture thermal neutrons, while boron 11 does not have this effect, so the boron in boron drugs actually refers to boron 10 isotope. However, the abundance (isotope content) is rarely examined in traditional drug development, and therefore the current regulations do not specify how much boron should be present in boron drugs, such as boron 10 phalanx (BPA, the only boron drug approved for marketing), and there are fewer publicly available data on the impact of choosing boron drugs with different abundance levels. In order to provide the best quality boron drug for patients, our researchers, based on a lot of research and experiments, have determined that the development of boron drugs, such as boron 10 farnesyl, should preferably be 99% or more in abundance, which has better clinical significance.
Anhui Poly recently received the NMPA issued the approval of the marketing application of chemical APIs, the involved product is magnesium hydroxide API.