【HC Pharmaceutical Industry Network】As a local 1.1 class of innovative drugs, Erlotinib was approved by the General Administration of Food and Drug Administration. From March 16 last year, it submitted a listing application and obtained the priority for evaluation. It is very smooth to be approved in one year. In the policy environment in which the oncology drug has received a number of concessions, the price of erlotinib has benefited the share price of its parent company, China Biopharmaceutical. In fact, this product was introduced from Nanjing Aidecheng, a small-scale research and development company that is not well-known in the industry. Another local tumor star innovation drug, apatinib, which was approved in the previous two years, was also transferred after the company was developed.
Good test data
Irrintinib is a small molecule multi-target kinase inhibitor that has dual roles in anti-tumor angiogenesis and tumor growth inhibition. In terms of mechanism of action, it is similar to the *anti-tumor angiogenesis agents sorafenib and pizopanb. From the molecular structure, it has a combination with cedirib, cabozantini and sunitinib. Very similar kinship. From this perspective, it is also a me-too-level innovative drug.
There are many controversies about the number of tumor-targeted drugs covering the target. The targeted therapy is accurate, covering more targets may be more effective, or effective for drug-resistant patients, but the target selectivity is low, and the side effects are more Large, commonly known as "dirtydrug". Multi-targeted kinase inhibitors are targeted therapies with more side effects, and clinically often have side effects that patients cannot tolerate. The phase III trial of erlotinib found that its side effects were small and mild, and it was a lucky one in drug development. Of course, this requires more clinical trials to confirm later.
The main clinical basis for the approval of erlotinib is a placebo-controlled advanced non-small cellLung cancerⅢPhase trial (ALTER-0303), because there is no standard treatment for stage III lung cancer, it is acceptable with placebo.
In the trial, the overall survival (OS) and progression-free survival (PFS) of erlotinib versus placebo were significantly prolonged, but PFS (4 months) was longer than OS extension (3.3 months) and survived. The curve quickly approached the placebo line after 15 months, does it suggest that some patients may have rapid progress after treatment with erlotinib? In addition, from the indirect comparison of pemetrexed and other chemotherapeutic drugs as a third-line drug for the treatment of advanced lung cancer, the overall response rate and survival time are basically the same as the results of the erlotinib.
In addition to Phase III clinical trials of lung cancer and soft tissue sarcoma, clinical trials of ilotinib in the treatment of other tumors are underway, includingGastric cancer、Colorectal cancer, medullary thyroid carcinoma, differentiated thyroid cancer, and esophageal squamous cell carcinoma. It has also obtained two orphan drug qualifications for the treatment of ovarian cancer and soft tissue sarcoma in the United States. Good product characteristics and huge market potential make erlotinib the flagship product of its parent company to enter the tumor market.
Three-line treatment population is narrow
Industry people are very concerned about the business prospects of erlotinib. From the rumored pricing strategy of 7 capsules per box, the price of 6200 yuan per month, the monthly treatment cost is about 16,500 yuan. Before being included in medical insurance, this cost is not cheap, and it is higher than imported chemotherapeutic drugs such as pemetrexed and other TKI-targeted drugs. In order to reduce the patient's economic pressure, the company launched a drug-donating policy: 8 boxes (3 months available), 8 boxes, and 8 boxes, and a lifetime of medicine. Compared with the overall survival time of more than 9 months of treatment with erlotinib, this drug-giving program is designed to be subtle.
Give higher levels of 1.1 innovative drugs like erlotinibSalesThe prediction is normal. In the past few years, both local inflammatory drugs such as ectinib and apatinib have achieved brilliant results, naturally letmedicineThe industry’s business return to erlotinib is also full of imagination. Its parent companyMarketingThe ability is very strong, otherwise, Erlotinib will not be included in the Chinese lung cancer treatment guidelines before listing, but can it reach the annual sales of several billion yuan?
The indication for erlotinib is a third-line treatment for advanced non-small cell lung cancer. The so-called third-line treatment is not clearly defined in the clinic. Chemotherapy, TKI, anti-angiogenesis and tumor immunotherapy are direct or indirect competitors. Although lung cancer has a high incidence in China, with a new NSCLC of 500,000 per year, patients with positive expression of kinesins such as EGFR, ALK, and ROS1 will choose the corresponding targeted drugs, and those who drive gene-negative patients may also choose chemotherapy and IO immunity. Treatment, anti-angiogenic therapy is just an option.
At the same time, it is necessary to consider that the survival time of patients with advanced lung cancer is short. If the pre-treatment has a great influence on the physical score or the patient's economic ability is too large, the target patients of the third-line treatment will be far less than the first-line treatment: every first-line treatment, The number of patients may be reduced by 2/3 or more. The third-line treatment patients have short survival time and poor economic burden, which have no small impact on the growth of erlotinib.
Competing products will be listed one after another
Although new indications such as soft tissue sarcoma may be approved soon, this is a rare type of tumor. At present, in addition to several large oncology specialist hospitals, there are routine patients, and the rate of misdiagnosis and missed diagnosis in other hospitals is not low. Coupled with existing targeted therapies, new chemotherapeutics and oncology immunotherapy, this market is unlikely to make a significant contribution to erlotinib in the short term.
The real chance of erlotinib is the first- and second-line treatment of lung cancer, such as partial replacement of bevacizumab in the market, or finding opportunities in high-rising digestive tract tumors. However, these markets are highly competitive, and chemotherapy, targeted drugs, and macromolecular drugs are emerging one after another, waiting for the very strong clinical data of erlotinib.
As for whether or not rolotinib can reproduce the successful performance of ectinib or apatinib, the author has a certain reservation. Eckinib was born in the era when local new drugs were extremely scarce eight years ago. It was strongly supported by the government at the beginning of its birth, and it only achieved sales of 1 billion yuan. Apatinib also rushed to the rapid spread of new drugs, seized the opportunity of new drugs for digestive tract cancer and quickly exploded.
The development threshold of small molecule targeted drugs is low, and the revision of the core parent ring is a new drug. From the perspective of product life cycle, the commercial value of small molecule targeted drugs is not as good as that of macromolecular drugs. Therefore, after the introduction of furlotinib, sovantinib, levaltinib and cabotetini, the multi-target small molecule drugs are listed one after another. Other products in a large number of pipelines cannot be listed one by one. Apatinib has also begun to enter the field of lung cancer, and there are still not more than a dozen varieties that are undergoing tumor immunotherapy.
Although there are many patients with cancer in China, the overall level of treatment for cancer is difficult to increase rapidly, and the pool of medical insurance is more intense. It is impossible to make every new drug a sales star. The advent of new drugs like erlotinib can give doctors a choice of treatments, and let patients have more hope for survival. This is a remarkable success in itself!