On January 15, Huadong Medicine Co.Ltd(000963) (000963. SZ) announced that Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., a wholly-owned subsidiary, had signed an exclusive product marketing agreement with Beijing sanoki Pharmaceutical Technology Co., Ltd. and Hainan sanoki Pharmaceutical Technology Co., Ltd., a wholly-owned subsidiary of Beijing shengnuoji Pharmaceutical Technology Co., Ltd, The exclusive marketing right of “First-in-class”, “icariin soft capsule”, is obtained from 27 provinces in Chinese mainland.
Icaritin soft capsule was approved to market conditionally on January 10 this year. It is used for unresectable hepatocellular carcinoma (HCC) that is not suitable for or patients refuse to accept standard treatment and have not received systemic treatment in the past. The peripheral blood composite markers of patients 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。 This is also another new example based on the modernization of traditional Chinese medicine and natural plant medicine after artemisinin and arsenic trioxide.
guided by clinical value Huadong Medicine Co.Ltd(000963) won the exclusive interest of the first innovative drug in 2022
In recent years, China’s drug regulatory reform has been deepened, and the drug review and approval adhere to the “four strictest” principles to ensure the safety, effectiveness and controllable quality of listed products. The guiding principles for clinical research and development of antitumor drugs guided by clinical value issued by CDE puts forward higher requirements for the research and development of antitumor drugs, reflecting the new regulatory concept of scientific evaluation of clinical benefits.
As the first domestic innovative drug approved by CDE for listing in 2022, icariin soft capsule not only provides a new choice for the treatment of advanced hepatocellular carcinoma in China and benefits patients in urgent need of better therapeutic drugs, but also affirms the innovative model and achievements of traditional medicine, and the market space growth potential of clinical application is expected.
According to GLOBOCAN 2020 data, in 2020, the number of new liver cancer cases (410000) and deaths (390000) in China accounted for 45.6% and 47.1% of the world respectively, ranking first in the world. In contrast, the overall 5-year survival rate of liver cancer in China is only 12.1%, and the 5-year survival rate of advanced liver cancer is less than 5%. The curative effect and survival prognosis need to be improved. The safety and differential treatment advantages of icariin soft capsule in clinical trials are expected to bring more treatment options to Chinese patients with advanced hepatocellular carcinoma.
Huadong Medicine Co.Ltd(000963) said it would make full use of its own commercialization ability to build a sales network of icariin soft capsules, accelerate the spread of drugs and meet the needs of patients. And Huadong Medicine Co.Ltd(000963) will also improve the construction of its own marketing network in this promotion, further improve its commercialization ability, and lay a solid foundation for the subsequent implementation of its own R & D achievements. In addition, under 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.
Some investors believe that Huadong Medicine Co.Ltd(000963) obtaining the promotion rights of icariin soft capsule this time is not only the embodiment of the company’s commercial resources and strength accumulation over the years, but also an important layout in the company’s innovation and transformation path. The company focuses on the three key areas of anti-tumor, endocrine and autoimmunity, and layout the differentiated market guided by the unmet clinical needs. As the first anti-tumor innovative drug approved in 2022, icariin soft capsule is expected to further fill the treatment gap of patients with advanced liver cancer in China and improve Huadong Medicine Co.Ltd(000963) the “territory” of commercialization in the field of anti-tumor innovative drugs.
The tumor field is the strategic field of Huadong Medicine Co.Ltd(000963) key layout, Huadong Medicine Co.Ltd(000963) 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.
Lu 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. “
the differentiated clinical value of icariin highlights the innovation and modernization of traditional Chinese medicine the results are expected
As an original natural oral small molecule immunomodulator with independent intellectual property rights in China, icariin soft capsule is a class of original new drugs in the world. It has received the support of 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.
Its core component is icaritin, an effective monomer compound extracted and purified from traditional Chinese medicine Epimedium. Icaritin can act on immune related signal pathways and exert unique anti-tumor effects through anti-inflammatory, regulating immune function and improving tumor microenvironment, From the perspective of modern medicine, the classical tumor immunotherapy theory of “Fuzheng treatment principle” is verified. 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.
It is reported that icariin soft capsule, as a milestone product of innovative traditional Chinese medicine, has experienced more than ten years of scientific and rigorous clinical trials and data demonstration. In the ten years from 2010 to 2020, icariin has successively completed five clinical studies, including clinical phase I dose exploration (2010-2012), clinical phase IIa dose and indication expansion (2012-2014) Clinical phase II efficacy and safety study of single arm advanced hepatocellular carcinoma (2013-2015) and phase III clinical validation (2017-2020) include icariin versus cinobufagin in the first-line treatment of advanced hepatocellular carcinoma.
For a long time, due to the high heterogeneity of Chinese patients with liver cancer, most of them are accompanied by hepatitis B virus (HBV) infection and abnormal immune function, and the background of basic liver disease is complex and serious. About 70% of patients are in the middle and advanced stage at the initial diagnosis. So far, there is no clear driver gene as a marker of advanced hepatocellular carcinoma for clinical precise treatment.
Therefore, in terms of scheme design, it supports the approved phase III clinical of icariin soft capsule. It adopts the composite biomarker and adaptive enrichment design. A total of 283 patients with advanced hepatocellular carcinoma without first-line systematic treatment were randomly assigned to icariin soft capsule treatment group (n = 141) or cinobufagin control group (n = 142).
In January 2021 last year, the interim analysis of the national multi center registered phase III clinical trial of icariin versus cinobufagin in the first-line treatment of patients with advanced hepatocellular carcinoma reached the preset main research endpoint. In May of the same year, the product marketing application was accepted by nmpa and planned to be included in the priority review for the treatment of unresectable hepatocellular carcinoma that had not received systemic treatment in the past.
As an original new drug independently developed by Chinese national pharmaceutical enterprises, the successful R & D of icariin soft capsule has set a modern model for the positive innovation, inheritance and development of traditional Chinese medicine. It not only provides a new choice for the treatment of advanced hepatocellular carcinoma in China, benefits patients in urgent need of better therapeutic drugs, but also affirms the innovative model and achievements of traditional medicine.
new drugs under the new deal the hot track of traditional Chinese medicine brings innovation dividends
Recently, the traditional Chinese medicine industry has accumulated a lot and continued to be hot. The state has successively issued a number of favorable policies to vigorously support the development of the traditional Chinese medicine industry. On December 30, 2021, the national medical insurance bureau and the administration of traditional Chinese Medicine issued the guiding opinions on medical insurance supporting the inheritance, innovation and development of traditional Chinese medicine, aiming to give full play to the advantages of the medical security system and support the inheritance, innovation and development of traditional Chinese medicine. In addition to the supporting policies on the cognition of medical insurance support, the adjustment of medical institutions into medical insurance, and the price management of traditional Chinese medicine services, the Opinions also launched corresponding policies on the payment scope, payment policy and fund supervision of medical insurance.
Then, in early 2022, the State Food and Drug Administration issued the guiding principles of communication and exchange technology based on the “Three Combinations” registration and evaluation evidence system (Exposure Draft), which proposed the key nodes of communication and exchange in clinical aspects of different registration classifications for new Chinese medicine developed under the traditional Chinese Medicine registration and evaluation evidence system combining traditional Chinese medicine theory, human experience and clinical trials Meeting material requirements and concerns, including human experience data.
Under the policy, the clinical research and development process of innovative traditional Chinese medicine has accelerated. Huaan Securities Co.Ltd(600909) the research report shows that a total of 905 clinical studies related to traditional Chinese medicine were carried out in China from 2014 to 2021, of which a large number of clinical studies were established from 2014 to 2015, which laid a solid foundation for the follow-up clinical development of traditional Chinese medicine. In recent three years, with the wave of innovative drugs, the phase III clinical proportion of traditional Chinese medicine has gradually increased, the non-standard phased research has gradually decreased, the transformation trend of early scientific research is good, and the evidence of evidence-based medicine is constantly enriched.
With the approval of innovative drugs of traditional Chinese medicine accelerating year by year, the track of traditional Chinese medicine gradually shows innovation dividends. From 2016 to 2021, a total of 20 new traditional Chinese medicine drugs were approved, including 12 in 2021, exceeding the total of 2017-2020. According to the field, there are many therapeutic drugs related to endocrine system and metabolic diseases, circulatory system diseases, skeletal muscle system diseases and respiratory system diseases. In 2021, a total of 12 new traditional Chinese medicine drugs were approved by nmpa. From 2017 to 2020, the number of new traditional Chinese medicine drugs approved each year was 1, 2, 2 and 3 respectively. Last year became the year with the largest number of new traditional Chinese medicine drugs approved in recent five years.
As a domestic traditional Chinese medicine innovation drug, icariin soft capsule has become the first innovative drug approved by the State Food and Drug Administration in 2022, which is of great representative significance. In the future, it will also inject a dose of cardiotonic injection into the follow-up development of drugs, patient groups and even traditional Chinese Medicine Innovation drugs. Huadong Medicine Co.Ltd(000963) will continue to increase its layout in the field of cancer in the future, focus on 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.
