Reconstructing the hope, Mövenpick Renaissance | Professor Shi Yuankai: the research and development status and challenges of domestic innovative drugs in the field of lymphoma and the listing prospect of repatitumab (Anpingxi ®).

In recent years, with the continuous emergence of new drugs, lymphoma treatment plans have been continuously updated, and the overall survival of lymphoma patients has been continuously improved
.
Because of its remarkable efficacy, anti-CD20 monoclonal antibody combined chemotherapy regimen has become the cornerstone of the first-line treatment of B-cell lymphoma such as DLBCL and FL
.
Recently, China's innovative biopharmaceutical company Shenzhou Cell Engineering Co.
, Ltd.
independently developed a new anti-CD20 monoclonal antibody - repatumab heavy listing, for China's lymphoma patients to add new treatment options
.
Professor Shi Yuankai of the Cancer Hospital of the Chinese Academy of Medical Sciences was invited to share the research and development status and challenges of domestic innovative drugs in the field of lymphoma and the listing prospect
of repatitumab.

Medical Pulse Communication: As an experienced researcher who has led many clinical trials, could you please introduce the research and development status of innovative drugs in the field of lymphoma and the progress of new drugs?

Lymphoma is a malignant tumor based on drug treatment, and the efficacy of drugs determines the treatment result
of lymphoma.
In the historical development process of tumor treatment, lymphoma treatment drugs in each important era are representative
.
In the 1940s, nitrogen mustard was the main treatment of lymphoma, cytotoxic drugs became the main drugs for tumor treatment before the 1990s, and after the 1990s, due to the listing of rituximab, tumor treatment opened the era of
targeted therapy.
In recent years, with the rise of immunotherapy, PD-1 monoclonal antibody has achieved significant efficacy in lymphoma treatment, among which relapsed and refractory classical Hodgkin lymphoma is the most effective tumor type
in the clinical application of PD-1 monoclonal antibody.
CAR-T cells have also made important progress in lymphoma treatment, opening a new era
of CAR-T cells for the treatment of malignant tumors.

Medical Pulse Pass: The domestic original research innovative drug repatumab has been successfully listed, as a Leading PI, what benefits do you think repatumab has brought to patients?

Repatumab is a new type of anti-CD20 monoclonal antibody, and the results of preclinical studies and clinical studies have shown that it is highly similar to the classic anti-CD20 monoclonal antibody - rituximab, which is highly similar
in efficacy and safety 。 The results of the phase III clinical trial showed that rituximab combined with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) regimen and repatitumab combined with CHOP regimen in the treatment of CD20-positive diffuse large B-cell lymphoma patients with initial treatment had no statistical difference in the best objective response rate within 6 cycles of chemotherapy, one-year disease progression-free survival, and three-year overall survival, and the safety was highly similar
.
These findings suggest that repatumab, as a novel anti-CD20 monoclonal antibody, will provide new treatment options
for patients with diffuse large B-cell lymphoma in the future.

Clinical studies: A large number of clinical studies have shown that there is no difference between repatumab and rituximab in terms of efficacy or safety, what are your expectations for the clinical application of repatumab?

The listing of a new drug must go through key registered clinical studies, and after meeting the listing standards, the drug is approved by the competent pharmaceutical administration department for listing
.
It is believed that in the clinical application process after the listing of repatumab, clinical application experience and real-world data will continue to be accumulated, and the efficacy and safety of the clinical application of repatumab will be more comprehensively displayed from a real-world perspective
.

Medical Pulse Pass: The research and development of anti-tumor drugs in the field of lymphoma in China is in a period of vigorous development, can you please introduce the challenges faced by China's lymphoma drug research and development and expectations for the future?

In recent years, China's drug research and development has entered the fast lane
.
A large number of statistics show that the number of clinical trials declared and the number of listed drugs in China are increasing
year by year.
The vast majority of drugs studied in clinical studies are drugs that target drugs, immunotherapy drugs, and new mechanisms of action
.
Studies have shown that these drugs can significantly prolong patient survival and can become a new choice
of treatment for patients after being approved for marketing.
However, oncology treatment still faces huge challenges
.
It is believed that in the future, with the deepening of the understanding of tumor pathogenesis, the continuous development of drug research, and the difficulty of overcoming difficulties, the emergence of new drugs is expected to further improve the survival of
patients on the existing basis.

Anti-CD20 monoclonal antibody is the cornerstone of lymphoma drug treatment, it is believed that with the domestic innovative anti-CD20 monoclonal anti-repatitumab market, it will further improve the accessibility of anti-CD20 monoclonal antibody in China, so that more lymphoma patients survive and benefit
.
At the same time, it is expected that China's drug research and development will be further developed to jointly help the "Healthy China 2030" to be realized
as soon as possible.

Professor Shi Yuankai

• Chief Physician, Department of Oncology, Cancer Hospital, Chinese Academy of Medical Sciences

• Ph.
  D.
  in Oncology Ph.
  D.
  supervisor

• He is the Appointed Professor of Peking Union Medical College, Chinese Academy of Medical Sciences

• Medical oncologist and clinical research expert of antineoplastic drugs

• Chairman of China Cancer Foundation, President of Xiong'an New District Medical Association, First and Second President of Oncologist Branch of Chinese Medical Doctor Association, Third and Fourth Chairman of Clinical Chemotherapy Committee of Oncology of Chinese Anti-Cancer Association, Fifth Chairman of Lymphoma Professional Committee of Chinese Anti-Cancer Association, First and Second Chairman of Anti-tumor Drug Professional Committee of Chinese Pharmaceutical Association, First Chairman of Oncology Branch of China Healthcare International Exchange Promotion Association, Member of Drug Evaluation Expert Advisory Committee of State Food and Drug Administration He is a member of the Science and Technology Innovation Advisory Committee of the Shanghai Stock Exchange, and the deputy editor-in-chief of the Chinese Medical Journal

• He has conducted more than 350 anti-cancer drugs and related clinical studies, published more than 350 articles with the first and/or corresponding author, edited more than 20 main translated works, and led the formulation of more than 10 national diagnosis and treatment norms, guidelines and expert consensus

• He has won the first prize and the second prize of the National Science and Technology Progress Award, a number of provincial and ministerial scientific and technological achievement awards, 7 national invention patents, the first national innovation medal, the national outstanding scientific and technological workers, the Chinese physician award and other awards
  .
  He was selected as a national-level candidate for the 100 Million Talents Project and enjoyed the special government allowance of the State Council

Editor: Su Meng

Reviewer: Evelyn

Typography: Uni

Execution: Small Garden