- Pyrrolitinib maleate (trade name: Erinib), indication for HER2-positive metastatic/advanced breast cancer, advanced non-small cell lung adenocarcinoma with HER2 mutation;
- Pyrrolitinib, an oral dual inhibitor of epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) tyrosine kinases, unlike the injectable form of trastuzumab (Herceptin) commonly used in breast cancer;
- Henry submitted a clinical trial application for pyrrolizidine in May 2011, submitted a marketing application in August 2017, and received priority approval from the CDE on September 26, 2018. li>
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Herceptin, a targeted breast cancer drug, has received a lot of attention in the past because of a national drug outage. The lack of a domestic anti-cancer drug is a worrying situation, as an imported anti-cancer drug has become a lifeline for breast cancer patients in China.
On August 13, the leading domestic pharmaceutical company Hengrui developed pyrrolizidine maleate tablets to complete the approval of the system, officially approved for marketing, this phase II clinical trial results in outstanding drugs, disease-free survival of up to 18.1 months, far beyond other similar products at home and abroad, and therefore the state drug regulator priority approval, from the application of clinical trials to approval for marketing only seven years.
Domestic drug companies rarely invest 500 million in research and development of innovative anti-cancer drugs
According to the announcement of Hengrui, a domestic listed pharmaceutical company developing pyrrolitinib, on August 3, 2016, the investment cost of the R&D project of pyrrolitinib maleate reached RMB 76 million, and on December 10, 2017, Hengrui released an announcement that the R&D project of pyrrolitinib maleate had invested about RMB 520 million in R&D.
Medical Dictionary logged on to the official website of the National Center for Drug Review and checked the drug clinical trial registration and information disclosure platform to find a total of 10 clinical trials registered for pyrrolitinib maleate tablets, mainly including HER2 expression-positive metastatic breast cancer, advanced non-small cell lung cancer with HER2 mutation and advanced gastric cancer.
It is reported that pyrrolizidine is the third chemistry innovation developed by Hengrui Pharma after ericiclib and apatinib.
This “superior” drug, which was favored in the development stage, has also achieved good results, and was supported by the Ministry of Science and Technology’s “Major New Drug Creation Science and Technology Special Project”; in May 2017, the results of a phase I study of pyrrolitinib in HER2-positive advanced breast cancer patients were published in the world’s top journal JCO. In May 2017, the results of a phase I study of pyrrolizidine in HER2-positive advanced breast cancer patients were published in full for the first time in the global top journal JCO (impact factor: 24.008), creating a precedent for China’s self-developed antitumor drugs to appear in the global top journals with only phase I studies.
What are the domestic breast cancer targeted drugs after the launch of pyrrolitinib?
According to the “Analysis of Malignant Tumor Incidence and Deaths by Region in China in 2014” released by the team of academician He Jie of the National Cancer Center in early 2018, the top incidence of malignant tumors in women is breast cancer, with 278,900 incidences and more than 66,000 deaths in 2014, which has become one of the most important diseases threatening women’s health in China.
At present, the only two domestic HER2-positive targeted drugs for breast cancer are lapatinib (Telmisar) and trastuzumab (Herceptin), both of which have been included in the national medical insurance catalog at reduced prices in 2017, with prices dropping by 41% and 67%, respectively, and considering 80% of medical insurance payments, the average monthly out-of-pocket amount for patients is only 1,470 and 1,770 yuan, and the pricing of pyrrolizumab after listing may also refer to these two The price of pyrrolitinib is likely to refer to these two varieties.
Herceptin was out of stock for a short period of time due to the surge in demand for the drug. According to Minene.com, a subsidiary of the Southern Institute of Drug Economics, the overall size of the domestic breast cancer drug market in 2016 exceeded 32 billion yuan, an increase of 11.67% over 2015, and the breast cancer treatment drug market is forecast to reach 40 billion yuan in 2018. The future addition of pyrrolizidine is expected to put some pressure on Herceptin’s market share monopoly position.
It is understood that among the top five species in the global breast cancer drug market, only Herceptin and paclitaxel are listed in China, and the other four drugs have not yet entered China, including paboxinib and patuximab, with global Herceptin sales reaching $7.534 billion in 2017.