Sorafenib: The World's First Approved Multi-target Anti-cancer Drug

1. Huateng Pharma https://en.huatengsci.com Sorafenib: The World's First Approved Multi-target Anti-cancer Drug Sorafenib is a kinase inhibitor drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (hepatocellular carcinoma), FLT3-ITD positive AML and radioactive iodine resistant advanced thyroid carcinoma. In December 2005, it was approved by the FDA as a first-line drug for the treatment of advanced kidney cancer. This is the only targeted drug approved by the FDA for the treatment of kidney cancer in the past 10 years, and it is a major progress in the treatment of kidney cancer. Since then, clinical trials have examined the efficacy of Sorafenib on more than 20 malignant tumors, confirming that Sorafenib was effective against CRAF, BRAF, V600EBRAF, C-Kit, FLT-3, as well as against CRAF, VEGFR-2, VEGFR-3, PDGFR- and other targets in tumor vascular target sites. Based on this, sorafenib became the world's first approved multi-target anti-cancer drug. Indications 1. Treat inoperable or distantly metastatic liver tumor cells 2. Treat inoperable kidney tumor cells 3. Treat local recurrence or metastatic, progressively differentiated thyroid

2. Huateng Pharma patients who are no longer effective for radioiodine therapy https://en.huatengsci.com Dosage Recommended dose: The recommended dose of sorafenib is 0.4 g (2x0.2 g) each time, twice a day, on an empty stomach or with a low-fat or medium-fat diet. Method of administration: Orally, swallow with a glass of warm water. Adverse reactions Common adverse events caused by sorafenib include skin rash, diarrhea, elevated blood pressure, and redness, pain, swelling, or blisters on the palms or soles of the feet. In clinical trials, the most common treatment-related adverse events were diarrhea, rash, fatigue, hand and foot skin reactions, hair loss, nausea, vomiting, itching, high blood pressure, and loss of appetite. In patients treated with sorafenib, the number of grade 3 and grade 4 adverse events accounted for 31% and 7% of the total number of adverse events, respectively, while the number of patients in the placebo control group was 22% and 6%, respectively. Drug Resistance treatment If the first-line treatment drug is resistant, the second-line medication plan must be considered. Currently, the United States has approved 3 second-line targeted drugs for liver cancer and 2 immunotherapy drugs. 1. In April 2017, the FDA approved regorafenib (Stivarga) for the second-line treatment of sorafenib drug resistant liver cancer, which has been marketed in China and covered by medical insurance. 2. In September 2017, the FDA approved nivolumab (Opdivo) for the second-line treatment of sorafenib drug-resistant liver cancer, which has been marketed in China. 3. In November 2018, the FDA approved pembrolizumab (Keytruda) for the second-line treatment of sorafenib drug-resistant liver cancer, which has been marketed in China. 4. In January 2019, the FDA approved cabozantinib (Cabometyx) for the second-line treatment of sorafenib drug-resistant liver cancer, which has not been marketed in China. 5. On May 10, 2019, the FDA approved ramucirumab (Cyramza) as a single-drug treatment for hepatocellular carcinoma (HCC) with alpha-fetoprotein (AFP) ≥400ng/ML who had previously been treated with sorafenib. Ramucirumab has not been marketed in China.

3. Huateng Pharma Huateng Pharma is a leading manufacturer of pharmaceutical API and intermediates. We provide many kinds of anti-cancer drugs intermediates such as Larotrectinib intermediates, Enzalutamide intermediates, Raltitrexed inter mediates, Alectinib intermediates, Granisetron intermediates and so on. https://en.huatengsci.com