On Feb. 12, 2023, Simcere Zaiming, a company that focuses on the development and commercialization of innovative oncology drugs, held a well-attended online press conference announcing that the first-in-class FDA and NMPA-approved therapy indicated to decrease the incidence of chemotherapy-induced myelosuppression, COSELA® (trilaciclib hydrochloride for injection), has been officially launched in China. The event was broadcast live by People’s Health , a website under People's Daily, the Newspaper of China’s Physicians、Medical Community and other media.
The conference, themed "Excellence and Virtue: Heavy Responsibilities on Zaiming," was held to celebrate the launch of COSELA® and the first anniversary of the launch of Envafolimab® (subcutaneously injected PD-L1 antibody) in China. Several leading clinical experts in oncology and academicians were invited to share their views on the ways to speed up the clinical development of innovative drugs through collaboration and innovation, tumor treatment during the pandemic, and improvement of the quality of life of patients.
Academician chairperson: Cosela® and Envafolimab® improve the quality of life of patients
In his opening speech, Yu Jinming, who is an academician of the Chinese Academy of Engineering (CAE) and professor from Shandong Cancer Hospital called for the development of more affordable, effective, and safe innovative drugs to improve the overall survival rate of cancer patients in China. Additionally, medical practitioners should also focus on improving the convenience of seeking medical treatment while maintaining the quality of diagnosis and treatment. Academician Yu Jinming believes that several innovative drugs in Simcere Zaiming's product portfolio have significant advantages in improving patients' treatment experience and quality of life, these include:
Envafolimab® , which isadministrated subcutaneously and requires no hospitalization, saves a great amount of time for patients and brings convenience to tumor treatment. COSELA® provides comprehensive bone marrow protection, which is expected to protect vulnerable chemotherapy patients and reduce the burden of toxicities and side effects. Endostar® is administrated intravenously for three days, which is recommended for the first time in the Guiding Principles of Clinical Application of Novel Anti-tumor Drugs as it improves patient outcome and efficacy.
Wang Xuehao, CAE academician and professor from Jiangsu Province Hospital, also recognized the differentiated value Envafolimab® brings to cancer patients in his speech:
In terms of clinical application, PD-L1 antibody is administrated through subcutaneous injection, which is safer and more convenient and has been recognized by a majority of medical practitioners.
Fan Jia, academician of the Chinese Academy of Sciences (CAS) and professor from Zhongshan Hospital of Fudan University said:
The pandemic across the country has affected outpatient and inpatient treatments of cancer patients in varying degrees, who are eager to receive treatments in a more convenient and equitable way. Envafolimab® is the world's first PD-L1 monoclonal antibody administrated through subcutaneous injection, which avoids the occurrence of infusion reactions and greatly shortens the duration of administration. It has demonstrated its unique advantages whether in the follow-up of patients or the management of medical resources.
Xu Binghe, CAE academician and professor from Cancer Hospital of the Chinese Academy of Medical Sciences, talked about the current treatment of small cell lung cancer (SCLC) in his speech:
The main treatments for SCLC, chemotherapy and combined immunotherapy, often lead to adverse reactions of myelosuppression, including decreased neutrophil, decreased platelets, and anemia, which increase the risk of infection and bleeding in patients and limit the dose of chemotherapy drugs, thereby affecting efficacy. The results of clinical trials of COSELA® show that the drug can reduce the occurrence of myelosuppression caused by chemotherapy and improve the quality of life of patients.
Professor Cheng Ying, president of the Small Cell Lung Cancer Experts Committee of the Chinese Society of Clinical Oncology and director of Jilin Cancer Center, as the principal investigator of the first Phase III registered clinical study on COSELA® in China, introduced that:
An upfront protective therapy has long been expected for clinical application which can effectively protect marrow's blood production function and have no impact on the effect of chemotherapy for patients at the same time. COSELA® is the world's first innovative drug providing comprehensive myeloprotection, which fills in the gap in medical science by enhancing effects of chemotherapy while reducing its risks. The data from the Phase III clinical study on COSELA® in China were published at the World Conference on Lung Cancer. COSELA® was also included in the CSCO Guidelines for Small Cell Lung Cancer (2022). The drug has been prescribed in Jilin Cancer Hospital for the first time in China, marking the official clinical application of this innovative drug in the country.
Xu Ruihua, chairman of the Chinese Society of Clinical Oncology and professor from Sun Yat-sen University Cancer Center said:
The management of myelosuppression adverse reactions of chemotherapy have been explored in the medical community for many years. For one thing, clinicians have been constantly exploring more effective doses of chemotherapy; for another, drugs that alleviate adverse reactions have been emerging, both of these events enable patients to better tolerate chemotherapy. COSELA® works in a new way that protects bone marrow function from chemotherapy-induced myelosuppression, giving the patients greater protection after receiving multiple courses of chemotherapy.
Other participants, including Professor Zhang Li from Sun Yat-sen University Cancer Center, Professor Zhou Caicun from Shanghai Pulmonary Hospital of Tongji University, Professor Zhou Jian from Zhongshan Hospital of Fudan University, and Professor Liu Ying from Jilin Cancer Hospital also shared their insights on how to protect the physical conditions of chemotherapy patients and how to improve the patients' quality of lives through rational and scientific medication.
Excellence and virtue: focus on cancer patients during the pandemic
At present, regular pandemic prevention and control have posed new challenges to oncologists regarding how to help cancer patients receive treatments and avoid the risk of infection, and to improve a patient’s quality of life.
Professor Shen Lin from Beijing Cancer Hospital, the principal investigator of the registered study on Envafolimab® in China, shared insights on the clinical application of the drug in the past year since it was launched:
As the world's first immunotherapy PD-L1 antibody drug for subcutaneous injection, Envafolimab® is also an innovative drug independently developed in China, specifically suitable for tumor treatment during the pandemic. During the long-term treatment, patients do not need to be hospitalized for infusion as this drug can be injected in community-based clinics, or even at home, which reduces the risk of gathering and consumption of medical resources. Over the past year, we have gathered more and more clinical evidence to prove that it is safe, effective, and very convenient to use. In addition to the original administration of 150 mg once a week, Envafolimab® can now be administrated 300 mg every two weeks, which makes the administration more convenient for patients.
Liang Jun, vice chairman of the Chinese Society of Clinical Oncology and professor from Peking University International Hospital, proposed in a special report on "Hospital and Department Management during the Regular Pandemic" that hospitals and departments should focus on inpatients by taking measures to shorten patients' stay in hospitals and reduce the frequency of round trips to and from hospitals, adjust the treatment plans for patients on a reasonable basis, and enhance tiered medical services to optimize resource allocation.
Professor Zhang Jun, deputy head of the Gastric Cancer Group of the Oncology Branch of the Chinese Medical Association and director of the Oncology Department of Ruijin Hospital of Shanghai Jiaotong University School of Medicine, also pointed out in his speech on "Tumor Patient Management during the Regular Pandemic" that tumor patients generally have immunodeficiency and have higher risks of COVID-19 infection and suffering from severe diseases after infection than the healthy population does. Therefore, to make a scientific treatment plan, attention should be paid to immune reconstitution, and consideration should be given to the speed of tumor development and the risk of COVID-19 infection.
Collaborative innovation: bringing hope of survival to patients
It takes joint efforts of multiple parties to drive the advancement of oncology medicine. Simcere Pharmaceutical Group is working on building the development model of collaborative innovation. The two innovative drugs, COSELA® and Envafolimab®, are the achievement of cooperative R&D efforts of a number of pharmaceutical companies and clinical units. Dr. Raj Malik, Chief Medical Officer of G1 Therapeutics, an overseas company that developed COSELA®, gave a speech through teleconferencing:
“I'd like to thank Simcere for its cooperation and support. In addition to being approved for marketing in China and America for the indication of small cell lung cancer, COSELA® is also to be further applied for the treatment triple-negative breast cancer (TNBC). Phase II study on TNBC showed that COSELA® extends the overall survival time of patients. We will continue to explore the immune-related mechanisms behind the data.”
To support the clinical research on tumors on a more accurate basis and better identify the pain-points of cancer patients, Simcere Pharmaceutical Group has established a wholly-owned subsidiary focusing on the anti-tumor field, Simcere Zaiming, which will be in charge of the marketing of COSELA®, Envafolimab®, Endostar®, and all the other innovative anti-cancer drugs under Simcere, as well as new drug R&D.
Dr. Tang Renhong, CEO of Simcere Zaiming, introduced the development strategy of collaborative innovation for Simcere Zaiming:
“Focusing on the R&D, production, and commercialization of innovative anti-tumor drugs, Simcere Zaiming strives to satisfy the huge unmet clinical needs in the field of cancer in China and even in the world by being committed to achieving breakthroughs in treatments. Simcere Zaiming currently has more than 35 ongoing research projects. Among them, 15 projects are in the clinical stage, and more than 20 projects of new-target drugs or differentially designed drugs are in the early development stage. Sticking to the R&D model of collaborative innovation, Simcere Zaiming will work with excellent research institutes, clinical institutions, and partners at home and abroad to provide clinicians with more effective treatments and bring hope of survival to more cancer patients.”
Gong Jinjie, Vice President of Simcere Zaiming, said:
At present, as a first-in-class new drug, COSELA® is sold at a significantly lower retail price in China than that overseas, which increases the accessibility of the imported drug urgently needed in clinical practice for a large number of chemotherapy patients in China. In the future, Simcere Zaiming will play an active role in working with oncologists across China on clinical projects, including expanding the application of new chemotherapy concepts for bone marrow protection in different tumor types and exploring the combined application of molecular markers and precision medicine. We are looking forward to more research achievements.