On January 15, Huadong Medicine Co.Ltd(000963) announced that its wholly-owned subsidiary, Sino US East China, signed an exclusive product marketing agreement (hereinafter referred to as the "cooperation agreement") with Beijing fenokee and Hainan fenokee, the wholly-owned subsidiaries of shengnuoji, and obtained the exclusive marketing right of "icariin soft capsule", a national class I innovative drug for small molecule immunomodulation, in 27 provinces of China.
Icariin soft capsule is an innovative small molecule immunomodulator for the treatment of advanced hepatocellular carcinoma. Its core component is icariin extracted and purified from traditional Chinese medicine Epimedium. On January 10, 2022, the State Drug Administration officially approved the marketing application of the drug conditionally for unresectable hepatocellular carcinoma that is not suitable or the patient refuses to accept standard treatment and has not received systemic treatment in the past. The patient's peripheral blood composite markers meet at least two of the following test indexes: AFP ≥ 400 ng / ml; TNF- α< 2.5 pg/mL； IFN- γ ≥7.0 pg/mL。 At present, icariin soft capsule has obtained 26 patent protection, such as use patent, crystal form patent and dosage form patent.
It is reported that shengnuoji has successfully synthesized icariin monomer compounds and is developing new preparations of icariin, so as to expand the application scope of icariin, improve drug efficacy and expand the global market. The preliminary results show that the new dosage form of icariin has better pharmacokinetic characteristics and stability, and shows a wide development potential of indications and convenience. Based on the safety advantages and unique immune regulation mechanism demonstrated in the preliminary clinical trials, shengnuoji also plans to promote the development of its clinical product pipeline for combined immunotherapy, mainly including: icariin soft capsule and its new preparation combined with oncolytic virus, anti-PD-1 antibody / anti-PD-L1 antibody, anti-CD137 antibody, radionuclide and other treatment methods. Under the condition of meeting the relevant conditions of the cooperation agreement, China, the United States and East China have the priority to sign the contract for the market promotion of new dosage forms and preparations of icariin developed by shengnuoji or products with clinical substitution effect with icariin soft capsules.
Huadong Medicine Co.Ltd(000963) it is believed that icariin soft capsule can act on immune related signal pathways and exert unique antitumor effects through anti-inflammatory, regulating immune function and improving tumor microenvironment. In addition, the design of its peripheral blood marker enriched population has opened a new model for exploring the precise treatment of Chinese patients with advanced liver cancer. The approval of the drug is based on the excellent data of phase III clinical study. A randomized controlled trial (RCT) meeting the Xi'An International Medical Investment Company Limited(000516) standard is adopted. Statistical analysis shows that icariin soft capsule can bring significant survival benefits to the target population and show better safety. The product has good market development prospects. In the future, with the expansion of more tumor species and the exploration of more joint strategies, icariin soft capsule has great market development potential.
Huadong Medicine Co.Ltd(000963) said that the tumor field is the strategic field of the company's key layout. The company has many years of experience in the development and industrialization of tumor drugs, and has a variety of listed anti-tumor products. Imgn853, developed in cooperation with immunogen in the field of antibody coupled drugs (ADC), is the first in the world to target folate receptors α (FR α) ADC of positive ovarian cancer is a drug under development for the treatment of fr α The key registered clinical trial of platinum resistant ovarian cancer with high expression in the United States has reached the main research end point. Its international multicenter phase III clinical study and China Phase I clinical study have completed the first subject enrollment in China and are progressing smoothly as planned; The mehuatinib developed in East China, the United States and China for the treatment of advanced non-small cell lung cancer is carrying out phase III clinical trial. At present, all subjects have been enrolled. It is expected to carry out market application after the phase III clinical study is completed in 2022.
Lv Liang, chairman of Huadong Medicine Co.Ltd(000963) said: "The company has a complete pharmaceutical care system and extensive market resources in the pharmaceutical industry. As the first innovative anti-tumor small molecule immunomodulator of traditional Chinese medicine in China, icariin soft capsule provides patients with a new treatment option. This time, the company cooperated with shengnuoji on the market promotion of icariin soft capsule to jointly create a win-win cooperation model of complementary advantages and coordinated development, which will It will have a positive impact on the development of both sides. In the future, the company will continue to increase its layout in the field of cancer, give priority to clinical needs and patients, cooperate with excellent enterprises at home and abroad, actively promote the R & D and industrialization process of new drugs under research and introduction, and finally realize Huadong Medicine Co.Ltd(000963) international layout and leading market competitiveness in the field of cancer. "
