In terms of innovative drugs, Hengrui has formed a virtuous circle of marketing, clinical batches and development batches. New drug creation in the fields of targeted therapy, immunotherapy, and ultra-long-acting insulin has achieved international leadership.Erecoxib
Erecoxib is a Class 1.1 innovative drug for osteoarthritis independently developed by Hengrui Medicine for 14 years. It was approved for sale in June 2011. It is a selective COX-2 inhibitor inhibitor against specific targets. Inflammatory and analgesic drugs have significant characteristics such as good efficacy, high safety, and low side effects.
According to statistics, the incidence of osteoarthritis in men in China is 58%, and it has risen to 65% -67% in women. There are more than 50 million osteoarthritis patients in China. The listing of irecoxib has brought good results to such patients , And effectively broke the monopoly of similar imported products, reducing the burden on patients.
Erecoxib research was included in the national "Eleventh Five-Year" and "Twelfth Five-Year" major new drug creation projects and national "863" key technology projects, and its compound patent won the 15th China Patent Gold Award. This product entered Jiangsu in 2015 Provincial medical insurance directory, entered the national medical insurance directory in 2017.Apatinib mesylate
Apatinib mesylate is a national class 1.1 innovative drug with independent intellectual property rights developed by Hengrui Medicine for 10 years. It was approved for marketing in October 2014, and was included in the national medical insurance catalog through negotiation in 2017.
The drug is a small molecule anti-angiogenesis targeting drug that has been proven to be safe and effective in advanced gastric cancer, and is also an oral preparation in gastric cancer targeting drugs.
In June 2015, Apatinib's clinical research was selected by the American Society of Clinical Oncology (ASCO) as the report of the conference, and was selected as the outstanding research of the annual conference. In July 2015, the phase II and phase III research reports of apatinib in the treatment of advanced gastric cancer were published in the international professional academic journal-American Journal of Clinical Oncology (JCO).
At the 2017 ASCO conference, there were as many as 22 research abstracts included in the selection meeting of apatinib-related basic and clinical research, which fully demonstrated that the product has been recognized by international peers.
In August 2018, a phase II clinical study of apatinib combined with etoposide for drug-resistant epithelial ovarian cancer was published in the "Lancet Oncology" (Lancet • Tumor). This is also the result of clinical research led by a gynecologic oncologist in mainland China since the publication of the international medical oncology journal "Lancet Oncology".Thiopenfigrastin Injection
The technology development research and phase II and phase III clinical research of this drug have been included in the national "Eleventh Five-Year" and "Twelfth Five-Year" major new drug creation projects. Thiopenfigrastin Injection
Thiofeigrastin injection is a bio-innovative drug independently developed by Hengrui Medicine for ten years. It is a G-CSF (Granulocyte Colony Stimulating Factor) product named chemically by the World Health Organization (WHO). Thiofigrastim. " This product uses innovative polyethylene glycol modified protein technology, which is more stable in structure, less ADA (anti-drug antibody), reduces immunogenicity, and is safe and reliable. Its innovative structure has won a number of international patents, as well as special scientific and technological support for the "Major New Drug Creation" of the 12th Five-Year Plan.
G-CSF includes two types of short-acting and long-acting. Short-acting G-CSF needs to be administered 1-2 times a day for each chemotherapy cycle and continuous administration for 5-14 days. Thiofigrastim belongs to long-term G-CSF is effective and only needs to be used once per chemotherapy cycle, which can improve patient compliance and provide new treatment options for the prevention of neutropenia. The listing of Thiopenfigelastine marks a substantial breakthrough for Hengrui Medicine in the field of biomedical innovation and will bring the gospel to patients.Pirlotinib Maleate
Pirlotinib maleate is an innovative drug independently developed by Hengrui Medicine based on the Phase II clinical research results, which has been given priority review by the State Food and Drug Administration.
According to "2015 China Cancer Statistics", breast cancer has become the most common malignant tumor in women in China, accounting for about 16.5% of the total incidence of cancer in all women. Pirlotinib maleate tablets provide a new treatment for patients with HER2-positive breast cancer recurrence or metastatic breast cancer.
In May 2017, "JCO" magazine published the full results of the phase I study of pirlotinib. China's self-developed anti-tumor drugs were listed in world-renowned journals based on phase I studies alone.
In May 2017, the journal Lancet Oncology, a professional journal in the field of oncology, also commented on the Phase 1b study of pirlotinib, and highly evaluated the excellent efficacy and better safety of the new drug.
In December 2017, the results of the Phase II clinical study of pirlotinib were reported at the San Antonio Breast Cancer Conference in the United States and included in the 2017 Annual Review of Breast Cancer Major Events.
Pirlotinib maleate tablets are one of the key projects supported by the National Twelfth Five-Year Plan for "Major New Drug Creation".
Pirlotinib is currently undergoing clinical research in the United States.Carelizumab for injection
Karelizumab for injection is a humanized PD-1 monoclonal antibody independently developed by Hengrui Medicine with intellectual property rights. It can specifically bind to PD-1 and block the interaction between PD-1 and its ligand. The T cells can restore the immune response against tumors and achieve the effect of treating tumors.
The product was declared clinical in December 2014 and approved for marketing in May 2019.
Currently, in addition to the approved indications for relapsed / refractory Hodgkin's lymphoma, three new indications have been submitted including hepatocellular carcinoma, advanced esophageal squamous cell carcinoma, and advanced or metastatic non-squamous cell carcinoma and non-small cell lung cancer. On the market, the efficacy and safety data obtained in Phase II clinical trials for hepatocellular carcinoma indications have been included in the priority review by the State Drug Administration.
Hengrui Medicine is currently conducting 32 studies in China to evaluate Carelizumab as a single drug or in combination with different treatments. In April 2019, a phase III clinical study of carelizumab for injection combined with apatinib first-line treatment for advanced hepatocellular carcinoma was carried out simultaneously in China, South Korea, the United States, Europe, Hong Kong, and Taiwan.