Together with the joint efforts, UCLI-CDE special session helps innovative drugs to reach the peak of the 7th International Summit Forum on Anti-leukemia and Lymphoma

Professor Wang Zhao and Professor Yang Wei presided

Dr.
Limin Zou gave a wonderful speech

Under the chairmanship of Professor Wang Zhao of Beijing Friendship Hospital affiliated to Capital Medical University and Professor Yang Wei of Shengjing Hospital affiliated to China Medical University, Dr.
Zou Limin, chief reviewer of the Center for Drug Evaluation of the State Medical Products Administration, shared the clinical review considerations of innovative drugs for hematological tumors from PI3K inhibitors
。 Since 2020, the Blood Indication Review Team has issued 5 technical guidelines
for the clinical development of new drugs for malignant hematological diseases.
Taking PI3K inhibitors as an example, although the FDA decided not to accept the single-arm registration of PI3K inhibitors in hematological tumors due to the safety of PI3K inhibitors, CDE started from Chinese clinical practice, according to the disease background, the mechanism of action and classification of PI3K, the drug review project management specification (GRP) for the effectiveness and safety of single-arm studies, the overall benefit risk evaluation, the confirmatory study design, the analysis of the reasons for the failure of overseas studies, The efficacy and safety data differences of Eastern and Western populations were reviewed, and the efficacy and safety of PI3K in Chinese patients were comprehensively reviewed, and finally conditionally approved for marketing
in China.
In the future, it is expected that R&D and regulatory agencies will form independent R&D thinking and independent review systems
based on China's clinical practice and the treatment needs of Chinese patients.

Professor Yang Wei commented that Dr.
Zou Limin shared that the review process of PI3K inhibitors can bring a lot of help
to clinicians in the process of participating in research and applying new drugs.
Thank you to all colleagues at CDE for bringing new drugs
to Chinese patients based on Chinese practice and scientific rigor.

Professor Ke Xiaoyan and Professor Liu Changxun presided

Dr.
Li Xin gave a wonderful speech

Under the chairmanship of Professor Xiaoyan Ke of Peking University Third Hospital and Professor Liu Changxun of Hulunbuir People's Hospital, Dr.
Li Xin, Head of Roche Global Drug Development China Center and Senior Vice President, shared the layout and progress
of drug development in the field of Roche lymphoma and leukemia 。 Roche's drug research and development is patient-centric, science-driven, and works with partners from all walks of life to continuously promote innovation and change
in blood disease treatment options.
In the field of lymphoma, Roche's CD20 monoclonal antibody R-CHOP regimen with rituximab plus chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) has been used as the first-line standard of care
for diffuse large B-cell lymphoma (DLBCL).
。 Following rituximab, Roche has surpassed itself through continuous innovation and developed an antibody-drug conjugate (ADC) vepotuzumab targeting CD79b, combined with R-CHP (rituximab, cyclophosphamide, doxorubicin, prednisone), further reducing the risk of progression, recurrence or death of treatment-naïve DLBCL disease and providing better treatment options
for first-line DLBCL patients.
Roche is also exploring the application
of dual-specific antibodies mosunetuzumab and glofitamab in lymphoma for T cells targeting CD20 and CD3.
In addition to drug discovery, Roche is committed to integrating and analyzing clinical research data to find new insights, accelerate drug development, and drive personalized patient care
.

Professor Liu Changxun said that rituximab has benefited more than 300,000 Chinese patients, and he expects Roche to continue to innovate and develop more new drugs
that benefit patients in the future.

Professor Chang Chunkang and Professor Jiang Zhongxing presided

President Jiang Hai made a wonderful report

Under the chairmanship of Professor Chang Chunkang of Shanghai Sixth People's Hospital and Professor Jiang Zhongxing of the First Affiliated Hospital of Zhengzhou University, President Jiang Hai of Rundong Pharmaceutical R&D (Shanghai) Co.
, Ltd.
shared the relevant content
of clinical CRO to help the development of innovative drugs in the post-epidemic era.
President Jiang Hai pointed out that in the next five years, the R&D endpoint of Phase III will still be dominated by oncology drug R&D, and jointly improve R&D efficiency and shorten R&D cycle by shortening the trial start-up time and shortening the R&D cycle
.
Under the influence of the epidemic, the uncertainty and uncontrollability of clinical research have increased, and the quality of clinical research is facing challenges
.
The CRO industry runs through the whole process of new drug discovery, R&D and development, and is at the core of
the pharmaceutical R&D industry chain.
In the post-epidemic era, clinical CRO will strive in patient-centered clinical research, multi-dimensional management of clinical trials, clinical information platform, digital medical and other aspects to help innovative drug research and development develop rapidly in the post-epidemic era full of changes
.

Professor Jiang Zhongxing commented that the epidemic has increased the difficulty of new drug research and development, but believes that in the future, drug developers and CROs will return the drug research and development process to normal track through the reform of the new drug research and development process
.

Professor Zhang Liansheng and Professor Yan Hua presided

Dr.
Tang Ling gave a wonderful report

Under the chairmanship of Professor Zhang Liansheng of the Second Hospital of Lanzhou University and Professor Yan Hua of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine, Dr.
Tang Ling, reviewer of the Center for Drug Evaluation of the National Medical Products Administration, shared the evaluation considerations of single-arm clinical trials to support the applicability of antitumor drug marketing applications
。 Dr.
Tang Ling said that CDE has issued three technical guidelines
for single-arm trials for anti-tumor use since 2020.
At the same time, the conditions considered in the review of single-arm R&D strategies were shared, and the possible reasons
why some single-arm clinical trials failed to translate into routine approval.
It is emphasized that single-arm studies are an option when randomized controlled trials (RCTs) are difficult to conduct, and that drug safety, efficacy and clinical needs need to be considered, and that single-arm trials need to be treated with greater caution
.

Professor Yan Hua commented that single-arm trials require innovative thinking when designing, and some of the experience of single-arm trial failures shared by Dr.
Tang will further improve and promote future drug research
.

Professor Zhang Mei and Professor Zhang Hao presided

Dr.
Huang Yunhong gave a wonderful speech

Chaired by Professor Zhang Mei of the First Affiliated Hospital of Xi'an Jiaotong University and Professor Zhang Hao of the Affiliated Hospital of Jining Medical College, Dr.
Huang Yunhong, reviewer of the Clinical Department of Biological Products of the State Medical Products Administration, analyzed the special points of clinical approval of
hematological tumor cell therapy drugs.
The clinical technical review of cell therapy products should consider drug innovation, R&D progress, efficacy and safety
.
At present, the regulatory challenges are mainly due to the large difference in the complexity and risk of cell therapy technology, the urgent clinical demand for safe and effective new therapies, the small scale of pre-marketing clinical trials, and the lag of technical evaluation methods, and the need to continuously establish and improve the standard system for cell therapy drug evaluation, strengthen the management of the whole process, and further improve the standardization of
clinical research.
The issuance of the Measures for the Administration of Drug Registration in 2020 further encourages drug R&D innovation, and it is expected that in the future, the research and development of hematological cancer therapeutics can drive multi-level innovation and development, multi-field cooperation, enhance the driving force of development in the pharmaceutical field, and accelerate the review and approval
of innovative cell therapy drugs.

Professor Zhang Hao said that this report elaborates on the current application status of hematological tumor cell therapy drugs, the challenges and the future direction of efforts, and brings a lot of help
to clinical experts and experts in the field of drug research and development.

Professor Zhu Zunmin and Professor Jia Zhilin presided

President Huang Hai made a wonderful report

Under the chairmanship of Professor Zhu Zunmin of the Institute of Hematology of Henan Provincial People's Hospital and Professor Jia Zhilin of the First Affiliated Hospital of Dalian Medical University, President Huang Hai of Fosun Kite Biotechnology Co.
, Ltd.
shared the first CAR-T China data and future opportunities
。 The ZUMA-1 study showed that aquilencel was treated with relapsed/refractory (r/r) DLBCL with a 2-year overall survival (OS) rate of 51%, a 5-year OS rate of 42.
6%, and an optimal overall response rate (bORR) of 83%.

。 More than 300 lymphoma patients have benefited from aquilencel in China, and the results of the 2-year Chinese bridging trial showed bORR of 79.
2%, the 2-year OS rate was 54%, and the post-marketing real-world research results showed bORR of 81.
5%, all of which are consistent with the results of ZUMA-1 studies, and Aquilencet has been recommended by the 2022 version of the NCCN guidelines and the 2022 version of the CSCO guidelines
.
It is expected that we will continue to explore the efficacy of CAR-T therapy in more hematological tumors in the future, lay out the application of CAR-T in solid tumors, and bring more hope
for cure to Chinese patients.

Professor Jia Zhilin commented that Aquilencel can bring significant efficacy in r/r DLBCL patients, has good application safety in Chinese patients, and is supported by commercial medical insurance and Huimin medical insurance, and expects more Chinese lymphoma patients and solid tumor patients to benefit
from CAR-T therapy in the future.

At the end of the meeting, Professor Ma Jun thanked all the experts for their chairing, reporting and discussion
.
It is believed that through this conference, experts in the field of drug research and development will have a better understanding of the anti-tumor innovation and drug regulatory review process and precautions, and look forward to providing more therapeutic weapons
for Chinese hematological cancer patients in the future.

Professor Ma Jun made a summary of the meeting