On January 15, Huadong Medicine Co.Ltd(000963) (000963) announced that the wholly-owned subsidiary Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (hereinafter referred to as “Zhongmei Huadong”) and the wholly-owned subsidiary of Beijing shengnuoji Pharmaceutical Technology Co., Ltd. (hereinafter referred to as “Beijing shengnuoji”) Hainan nokotchi Medical Technology Co., Ltd. (Hainan “nokchi”) signed exclusive marketing agreement (referred to as “cooperation agreement”), and obtained the exclusive marketing right of “small molecule immune regulation” First-in-class, a “national EPI” soft capsule of 27 countries in Chinese mainland.
cooperative products have been supported by major scientific and technological projects for many times
Icariin soft capsule is an innovative small molecule immunomodulator for the treatment of advanced hepatocellular carcinoma. Icariin molecules bind IKK directly α， It also inhibits TNF- α For ikk-nf- κ The activation of B signaling pathway can inhibit the expression of PD-L1, reduce the MDSC of inhibitory immune cells and activate IFN- γ Positive CD8 + T cells play an immunomodulatory and antitumor role.
As an original natural oral small molecule immunomodulator with independent intellectual property rights in China, icariin soft capsule is an original new drug of the first in class in the world. Its core component is icariin, an effective monomer compound extracted and purified from the traditional Chinese herbal medicine Epimedium (icaritin, named “acoradine” by shengnuoji). The clinical phase III test results show that, Compared with cinobufagin in the first-line treatment of advanced hepatocellular carcinoma, icariin soft capsule can significantly prolong the overall survival benefit of subjects, and the median overall survival benefit (MOS) of enriched population is 13.54 months vs. 6.87 months (HR = 0.43, P = 0.0092); Significantly improve the quality of life and prolong the median to deterioration time (TTD); The safety performance is good, and the overall incidence of adverse reactions has obvious advantages compared with the existing first-line treatment.
Icariin soft capsule has been supported by five major scientific and technological projects of “major new drug creation” such as the eleventh five year plan, the Twelfth Five Year Plan and the thirteenth five year plan, and was included in the priority review procedure in May 2021. At present, icariin soft capsule has obtained 26 patent protection, such as use patent, crystal form patent and dosage form patent.
At present, 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) further expansion of tumor innovative drug pipeline
Huadong Medicine Co.Ltd(000963) believes that icariin soft capsule can act on immune related signal pathways and play a unique anti-tumor effect through anti-inflammatory, regulating immune function and improving tumor microenvironment. In addition, the design of enriched population of peripheral blood markers has opened a new model for exploring the precise treatment of patients with advanced liver cancer in China. 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.
It is reported that the tumor field is the strategic field of Huadong Medicine Co.Ltd(000963) 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. “
