Health & Beauty

According to the information displayed by the State Drug Administration on July 13, the innovative chemotherapy drug Kesaila® (Tracicril Hydrochloride for Injection) jointly developed by Simcere (02096.HK) and G1 Therapeutics has obtained the Approved for listing in China, it is used for the prevention of myelosuppression caused by chemotherapy in patients with small cell lung cancer.

Preemptive protection of bone marrow cancer patients "reduces the burden"

As a traditional anticancer therapy, chemotherapy uses some cytotoxic drugs to kill rapidly dividing tumor cells, thereby inhibiting or even killing tumors. But at the same time, the toxicity of chemotherapeutic drugs will also affect the normal cells of the human body, thus triggering a series of toxic and side effects.

In addition to the symptoms of hair loss, nausea and vomiting that cancer patients often experience during chemotherapy, the most dangerous side effect of chemotherapy is the damage to the human hematopoietic factory - bone marrow.

According to the "Expert Consensus on Diagnosis and Treatment of Myelosuppression Caused by Antineoplastic Drugs", more than 80% of chemotherapy drugs can cause myelosuppression, and 64% of chemotherapy patients are affected by myelosuppression.

The so-called "myelosuppression" refers to the decrease in the activity of bone marrow hematopoietic stem cells and various precursor cells.

The toxic and side effects of bone marrow suppression not only make patients more prone to infection and other symptoms, but even threaten their lives in severe cases. In addition, it may also lead to reduction or delay in the administration of chemotherapy, which directly affects the therapeutic effect.

In order to neutralize the decline of blood cells caused by myelosuppression after chemotherapy, the current clinical treatment mainly uses cytokine drugs that promote blood cell regeneration, commonly known as "bone marrow support therapy". The mechanism of action of these drugs is that when chemotherapy drugs damage the bone marrow, they can promote the regeneration of various blood cells.

According to Cheng Ying, the leader of the clinical study of tralacil in China and the president of Jilin Cancer Hospital, the effect of cytokine drugs to increase blood cells is unstable, and long-term use of the drug in patients can cause bone marrow depletion and new adverse reactions such as bone pain. Clinically, we have been expecting a therapy that can preemptively protect the bone marrow, avoid being damaged by chemotherapy drugs, and kill cancer cells.

According to the information displayed on the official website of the State Drug Administration, the approved indication of Cocyla is for prophylactic administration in patients with extensive-stage small cell lung cancer (ES-SCLC) receiving platinum-containing drugs combined with etoposide. Simply put, its main role is to prevent myelosuppression caused by chemotherapy, so as to reduce the incidence of myelosuppressive side effects.

Professor Cheng Ying also said that the innovation of the drug is reflected in the reverse development of the current popular target CDK4/6, which temporarily blocks hematopoietic stem cells in the bone marrow by inhibiting the activity of the cell cycle switch-CDK4/6 protein kinase. In the G1 phase of the cell cycle, the cells are temporarily stopped from dividing, so as to "evade" the killing of chemotherapy drugs, just like making bone marrow stem cells put on "bullet armor" before chemotherapy. And this "bullet armor" is reversible. After the tumor cells are killed, the bone marrow cells that are firmly protected by the "bullet armor" of Traxil can be recovered for normal hematopoiesis.

Save the cost of treatment and reduce the burden of medical costs

According to the results of three randomized, double-blind, placebo-controlled pivotal clinical studies in patients with extensive-stage small cell lung cancer (ES-SCLC), patients who received intravenous The proportions of severe neutropenia and grade 3/4 thrombocytopenia were significantly lower than those in the placebo group, and the use of tralaciride also significantly reduced granulocyte colony-stimulating factor (G-CSF), red blood cell transfusion and other support therapeutic application.

This means that the myeloprotective effect of tracilidol can not only reduce the incidence of myelosuppression, but also greatly save the medical costs of traditional bone marrow support therapy and blood transfusion for cancer chemotherapy patients.

According to a study by the Chest Hospital Affiliated to Shanghai Jiaotong University, the per capita chemotherapy for lung cancer patients in my country is 4.5 times, and the cost of each hospitalization for the treatment of grade I-IV myelosuppression accounts for 8.43%, 18.37%, 40.09% and 40.09% of the direct cost of chemotherapy. 46.62%.

In addition, according to the model calculation of the paper published in the "Journal of Shanghai Jiaotong University (Medical Edition)", 2.8 million patients in China need chemotherapy every year, and only the bone marrow suppression in the toxic and side effects of chemotherapy will have to bear an additional cost of more than 35 billion yuan. Treatment costs.

It can be said that while the body is facing the test of toxic and side effects, the families of millions of chemotherapy patients in China and the national medical insurance finance also bear huge economic costs for the side effects caused by chemotherapy.

According to the clinical director of Simcere Pharmaceutical Group, the co-developer of Traxilide in China, the heavy burden of chemotherapy patients due to bone marrow damage has always been a concern of the company.

"We are concerned that cancer patients in China and the United States are faced with a heavy burden of chemotherapy side effects, so Simcere's BD department prioritized targeting the world's most cutting-edge scientific research results in this field, and discovered Qula, which was developed by G1 in the United States. Xili.” The above-mentioned person in charge of Simcere Pharmaceuticals also said that the drug was previously recognized by the FDA as a breakthrough therapy in the United States, and after the company completed clinical development for Chinese patients, it also quickly obtained “Priority Review” by the State Food and Drug Administration of China .

Dr. Renhong Tang, Executive Director and Co-CEO of Simcere Pharmaceuticals, said, "This reflects the high attention and support of the drug regulatory authorities in China and the United States for innovative treatments in the field of cancer chemotherapy, and also gives us great confidence. Shengsheng Pharmaceutical will focus on resources, accelerate the implementation of drugs, and ensure the availability of drugs for patients."