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Hehuang Pharmaceutical's "Second Challenge" with Furoquantinib by the US FDA!

Recently, Hehuang Pharmaceuticals and Takeda announced that the US Food and Drug Administration ("FDA") has accepted the application for the launch of a new drug, fluquintinib, for the treatment of adult patients with metastatic colorectal cancer after treatment, and will prioritize its review. Furoquantinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptor ("VEGFR") -1, -2, and -3. If approved, furoquantinib will become the first and only highly selective inhibitor approved in the United States for the treatment of metastatic colorectal cancer, targeting all three VEGF receptors. The target review date for the Prescription Drug User Payment Act (PDUFA) proposed by the FDA regarding the new drug's marketing application is November 30, 2023. It is worth mentioning that by the end of last year, Hehuang Pharmaceutical had already started rolling out its application for the launch of a new drug called furoquantinib for the treatment of refractory metastatic colorectal cancer to the US FDA, and it is expected to officially complete its submission in the first half of 2023. This is the second FDA breakthrough with Huangyao Furoquantinib, which is worth looking forward to.

Recently, Cyda has announced the official launch of ADAVELT Active (pyridineamide), a sterilizer derived from a natural and new mechanism, which can protect crops from various diseases that may affect the production of crops. At present, products containing ADAVELT Active activated ingredients have been approved in Australia, Canada and South Korea. In the next few years, Kylvywa plans to seek appropriate crop registration under the approval of regulatory agencies and actively supply ADAVELT Active series products.

Recently, Hengrui Pharmaceutical subsidiary Shanghai Shengdi Pharmaceutical Co., Ltd. received the "Pharmaceutical Registration Certificate" issued by the State Drug Administration (NMPA) to approve the company's independent PD-L1 inhibitor Adeberley Midgrot (iResearch Profit) combined with first-line therapy for patients with Platinum and Ryposidin for patients with ES-SCLC (ES-SCLC). Adebergazab became my country's first independent R & D PD-L1 inhibitor to be approved by small cell lung cancer indications, bringing new treatment options to patients. At this point, Hengrui Pharmaceutical has been approved to be listed 12 innovative medicines.

February 22 2023, Shanghai—Abbisko Therapeutics Co., Ltd. (“Abbisko” hereafter) today announced that ABSK121, a next-generation small molecule FGFR inhibitor overcoming FGFR resistance mutations, has obtained clinical trial approval from the National Medical Products Administration (“NMPA”) of the People’s Republic of China, and will soon launch the Phase I clinical trial for the treatment of patients with advanced solid tumors in China. This marks another major developmental milestone for this program, which was also granted IND approval from US FDA recently. ABSK121 is a small molecule FGFR inhibitor that was discovered and developed by Abbisko to address both primary FGFR2 and FGFR3 oncogenic alterations and those predicted to drive acquired resistance to current FGFR-targeted therapies, including gatekeeper, molecular brake, and activation loop mutations observed in cholangio, bladder and many other types of cancers. In preclinical studies, ABSK121 demonstrated superior potency and broadest coverage across a wide range of clinically relevant mutations that drive primary disease and acquired resistance.

2023 The first fluorine-containing drug was approved. 2023.01.27 Eli Lilly's Loxo Oncology announced accelerated FDA approval of its BTK inhibitor Jaypirca (pirtobrutinib), For adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least 2-line system therapy after prior treatment including a BTK inhibitor。 Jaypirca is the first and currently only non-covalent reversible BTK inhibitor approved by the FDA.

Recently, Kyrva launched a new product Novixid herbicides (1.3%chloropyraidine +2.1%faw -sulfonamine) in a event at the event of Tyronnana, India. The event emphasizes the importance of weed management to improving crop output and farmers' profitability. Novixid is displayed as future technology. This product can effectively control ALS (acetyl lactase), ACCASE (acetyl olidase A carboxylase), HPPD (hydroxylphenyl acetonase), and weeds that have resistant to HPPD inhibitors. It also has good toxicology and ecological toxicology characteristics, which is good for soil health and environment. This makes Novixid as a unique product that effectively plays a role in various conditions and irrigation environments.

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