Keytruda was approved in 5 months, and Merck joined the battle with the strongest "PD-1"
Pharmaceutical Network July 27th, July 26, Merck Corporation announced that its PD-1 inhibitor drug Pembrolizumab (Pembrolizumab) officially approved by the Chinese National Drug Administration for unresectable first-line treatment failure Or treatment of metastatic melanoma.
According to the reporter, the product name of the product in the European and American markets is Keytruda, which has long been highly concerned by the Chinese pharmaceutical industry. Previously, Opdivo developed by PepsiCo Squibb benefited from the green channel of priority review. The urgently needed PD-1 drug for this patient was approved in China, and it was less than 9 months from the time of application for listing.
The Pabolizumab, known as the strongest "PD-1", was also eligible for a priority review, and it took only more than five months from filing to approval. Dr. Li Zhengqing, General Manager of Merck East China R&D Center, said: “With the proven efficacy of tumor immunotherapy, the importance of PD-1 inhibitor drugs represented by Pabolizumab is becoming more and more important. We are very pleased that Paboli The resistance can be approved in a short period of time, which means that Chinese patients will benefit from this innovative treatment plan to improve the quality of life and prolong life."
Remodeling the treatment of cancer
Melanoma is a malignant tumor derived from melanocytes. It is the most malignant cancer in skin cancer. It is also one of the fastest growing malignant tumors in China. The annual growth rate is 3% to 5%, which has become serious. An important disease that threatens the health of Chinese residents.
Melanoma deteriorates rapidly and is prone to distant metastasis. Therefore, once advanced into the tumor, the previous treatment is relatively ineffective, and the prognosis and quality of life of the patient are greatly affected. Research data show that in the event of tumor metastasis, the 5-year survival rate of melanoma patients is only 4.6%.
“In the past few decades, our approach to malignant melanoma has been very limited. With traditional treatment options, patients have very low long-term survival benefits.†Pablolinizumab, the leading investigator of Chinese melanoma KEYNOTE-151 clinical trial, China Professor Guo Jun, chairman of the Committee of Clinical Oncology (CSCO) Malignant Melanoma Expert Committee, president of China Melanoma Association and vice president of Peking University Cancer Hospital, pointed out: "Malignant melanoma is one of the most sensitive tumors for immunotherapy response. In foreign countries, PD-1 inhibitors represented by Pabolizumab have long been the standard treatment for malignant melanoma. Nowadays, Pabolibumab is approved in China, which means that patients with advanced malignant melanoma finally have the world. The combined treatment plan will also promote the change of the treatment pattern of advanced malignant melanoma in China."
Merck's Keytruda is listed one step later than PepsiCo's Opdivo, but many insiders believe that Merck is more likely to be a big winner in this field.
Because on ASCO 2018, Keytruda's data is amazing, and almost everyone believes that Keytruda has undoubtedly seized the throne of lung cancer immunotherapy. However, competitors seem to be quite dissatisfied with this. In their view, the difference between their own drugs and Keytruda is small, or there is no difference at all.
Investors care more about this data than anyone else. They want to know if Roche and BMS can catch up with Merck. After all, the latter has obtained data on survival benefits in five randomized controlled lung cancer trials.
Although Roche also released Tecentriq's positive data for squamous lung cancer at ASCO, BMS also highlighted the excellent performance of Opdivo in the new biomarker population. However, industry insiders pointed out: "Because Keytruda's latest victory masks the advantages of the former two, investors' enthusiasm for these two companies is obviously less than that of Merck."
PD-1 inhibitors are on the market faster,
Increasing competition
Professor Li Jin, director of the Chinese Society of Clinical Oncology (CSCO) and director of the Department of Oncology Medicine of the Oriental Hospital of Shanghai Tongji University, stressed: "The era of cancer immunotherapy has arrived and will become one of the main means of cancer treatment worldwide. China is no exception. We must work together to promote the development of immuno-oncology in China, team up with innovative drug research and development companies, carry out immunotherapy education, accompanying diagnostic construction and cross-cancer discipline construction, maximize the advantages of immunotherapy, and let more doctors participate. Let the wider patient population benefit from it."
In recent years, immunotherapy has received increasing attention in the field of cancer. It is predicted that the global immunotherapy market will grow from US$61.9 billion in 2016 to US$119.39 billion in 2021, with a compound annual growth rate of 14.0%. Domestic innovative pharmaceutical companies have also increased research and development, and there are nearly 100 related companies.
On February 8 this year, CDE officially released the "Basic Requirements for Data for Anti-PD1/PD-L1 Monoclonal Variety Declaration and Listing", which mentioned that "there are currently 5 anti-PD1/PD-L1 monoclonal antibodies in the world. The drug is marketed, and the monoclonal antibody drugs targeting PD1 include Keytruda (Pembrolizumab) and Opdivo (Nivolumab). Monoclonal antibody drugs targeting PD-L1 include: Tecentriq (Atezolizumab), Bavenci (Avelumab) and Imfinzi. (Durvalumab). There are 16 similar products in China that have received clinical approvals and clinical trials in different tumor types."
For the plan after the approval of the PD-1 inhibitor, Mervyn China President Luo Wanli said frankly: "We sincerely appreciate the Chinese government's efforts to promote the introduction of innovative drugs into China and speed up the review and approval of new drug reviews. After the approval of Pabolibumab, We will continue to work with governments, medical institutions, experts and healthcare professionals to expand the other indications of Pabolizumab in China, while rapidly expanding its accessibility and allowing more Chinese cancer patients to benefit from cutting-edge immunotherapy. â€
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