Hengrui Medicine 1 new drug revelutamide tablets have been approved for marketing, with 11 innovative drugs on the market ###
Recently, National Medical Products Administration approved Hengrui Medicine’s independently developed class 1 new drug revelutamide The film (trade name: Aerion) was launched. Since then, the number of innovative drugs launched by Hengrui Medicine in China has increased to 11.
Reverutamide is the first new androgen receptor (AR) inhibitor independently developed in China. This conditional approval is for the indication of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumor burden. This marketing application was included in the priority review and approval process by the State Food and Drug Administration in October 2021 as a breakthrough therapy variety. This official approval will bring new treatment options to Chinese patients with prostate cancer .
Prostate cancer has a high incidence in the world
Domestic metastatic prostate cancer has a large clinical demand
Prostate cancer is currently the second most common malignant tumor in men in the world and the fifth most common cause of death. According to the GLOBOCAN 2020 report, there will be approximately 1.41 million new cases of prostate cancer worldwide in 2020 (accounting for 14.1% of all new malignant tumor cases in men, second only to 14.3% of lung cancer) and approximately 380,000 deaths (accounting for 14.1% of all new malignant tumor cases in men). 6.8% of deaths from malignant tumors) [1]. The incidence of prostate cancer in China is significantly lower than that in Western countries, but it has shown a significant upward trend in recent years and has become the most common malignant tumor of the male genitourinary system. In 2015, there were about 60,000 new cases of prostate cancer and about 27,000 deaths in China [2]; and according to World Health Organization research data, there will be about 115,000 new cases of prostate cancer in China in 2020, and about 27,000 deaths. 51,000 cases[3].
In addition, the proportion of metastatic patients among newly diagnosed prostate cancer patients in my country is much higher than that in Western countries, which is one of the main reasons why the overall survival rate of prostate cancer patients in my country is significantly lower than that in Western countries [4]. Previous epidemiological studies have shown that about 40% to 70% of newly diagnosed prostate cancer patients in my country are already in the metastatic disease stage [5, 6, 7], while in Western countries this proportion is less than 10% [8, 9] . Therefore, Chinese patients have an even more urgent clinical need for new drugs to treat metastatic prostate cancer.
The growth of prostate cancer cells is characteristically androgen-dependent, so newly diagnosed metastatic prostate cancer is basically mHSPC. After patients with mHSPC receive androgen deprivation therapy (ADT) alone, the disease will progress to metastatic castration-resistant prostate cancer on average 18 to 24 months [10]. At this time, the malignancy of the tumor has increased, ADT treatment alone is no longer effective, and the patient's median overall survival (OS) is less than 3 years [11, 12]. In comparison, new AR inhibitors or CYP-17 inhibitors (ie, abiraterone acetate , which inhibits androgen synthesis) combined with ADT to treat mHSPC can effectively reduce the risk of disease progression or death and prolong OS [13-15]. Currently, authoritative guidelines at home and abroad, including the Chinese Society of Clinical Oncology (CSCO) Prostate Cancer Diagnosis and Treatment Guidelines (2022 Edition) and the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines: Prostate Cancer (2022 Edition), are The level of evidence for new AR inhibitors combined with ADT therapy was upgraded to Level I, and its clinical application in mHSPC was recommended.
Currently, there are two new AR inhibitors approved for mHSPC indications in the world, but only one was approved in China in 2020, so the treatment options for domestic patients are still very limited. In addition, the onset characteristics (tumor burden, underlying diseases, etc.) and current status of diagnosis and treatment of prostate cancer in China are somewhat different from those in foreign countries. Finding treatment options that are closer to the current status of diagnosis and treatment of Chinese patients has always been a concern and urgent issue for Chinese clinicians. .
China independently developed a new AR inhibitor
Reverutamide brings new options to Chinese patients
Reverutamide is a new AR inhibitor with independent intellectual property rights developed by Hengrui Medicine. In 2018, it won the national "Thirteenth Five-Year Plan" Support for major new drug creation and science and technology projects. As a new type of AR inhibitor, revelutamide has made important innovations in the molecular structure of the drug, which enables the drug to have high AR inhibitory activity while significantly reducing blood-brain barrier permeability compared with similar products on the market and lowering the central nervous system. toxicity, and have more optimized pharmacokinetics characteristics [16].
The approval of revelutamide was mainly based on a multi-center, randomized, controlled phase III clinical study (CHART). This study aims to evaluate the effectiveness and safety of revelutamide combined with ADT compared with standard treatment combined with ADT in the treatment of mHSPC patients with high tumor burden. A total of 654 patients were enrolled, with domestic patients accounting for 90.4%, which is closer to the current status of diagnosis and treatment of Chinese patients. . The results of the
CHART study show that revelutamide can significantly prolong the primary endpoints of OS and radiographic progression-free survival (rPFS, based on independent review), death and disease compared with standard treatment in subjects with mHSPC with high tumor burden. The risk of progression was reduced by 42.0% and 53.9% respectively; on secondary and exploratory endpoints, including investigator-assessed rPFS, time to prostate-specific antigen (PSA) progression, time to next bone-related event, and time to next anti-prostate cancer Patients in the revelutamide group also showed significant benefits in terms of starting time, objective response rate, PSA response rate, PSA undetectable rate and quality of life [17].
The above research results have been presented as an oral report at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in June 2022, demonstrating the important progress of China's innovative drugs for urinary tumors on the international stage. Based on this research result, revelutamide has received Level I recommendation (Class 1A evidence) from the Chinese Society of Clinical Oncology (CSCO) Prostate Cancer Diagnosis and Treatment Guidelines (2022 Edition), and is expected to provide a new treatment option for Chinese prostate cancer patients.
Hengrui Medicine continues to output innovative results
Strives to benefit more patients
Compared with European and American countries, the clinical application of new AR inhibitors in my country is relatively lagging behind. As the first independently developed new AR inhibitor in China, the launch of revelutamide will effectively promote the application accessibility of new AR inhibitors, allowing more prostate cancer patients to benefit from standard treatment.
In addition to the CHART study on which this approval was based, there is another phase III study of revelutamide, namely the international multi-center, randomized, controlled III of revelutamide in the perioperative period for the treatment of high-risk prostate cancer. Phase 1 clinical study has also started enrollment in September 2021.
With the approval of revelutamide, the number of innovative drugs launched by Hengrui Medicine in China has increased to 11. As a representative enterprise in China's innovative pharmaceutical industry, Hengrui Pharmaceuticals has long adhered to the innovation-driven development strategy, worked hard and accumulated rich experience, and has accumulated strong innovation strength and fruitful innovation results. Currently, in addition to the 11 innovative drugs that have been launched on the market, the company has more than 60 innovative drugs under clinical development, and more than 250 clinical trials have been conducted at home and abroad, forming a rich and echeloned product pipeline. At the same time, the company has also established scientific and technological platforms such as a national enterprise technology center and postdoctoral research workstation, a national molecular targeted drug engineering research center, and a special incubator base for "National Major New Drug Creation", and has built a number of new technology platforms with independent intellectual property rights. , including proteolysis targeting chimeras (PROTAC), molecular glues, antibody drug conjugates (ADC), bi/multispecific antibodies, gene therapy, mRNA, bioinformatics, translational medicine , etc., for continuous output High-quality R&D results lay a solid foundation.
In the future development, Hengrui Medicine will always adhere to the mission of "technology-based, creating a healthy life for mankind", unswervingly implement the two-wheel drive strategy of technological innovation and internationalization, and strive to develop more new and good drugs to serve health China, benefiting a large number of patients.
Reference:
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[14]. Armstrong AJ, Szmulewitz RZ, Petrylak DP, et al: ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer . J Clin Oncol 37:2974-2986, 2019
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