Fuhong Hanxuan anti-PD-1 monoantigen multiple indications into the critical stage of clinical stage

For the independent research and development of anti-PD-1 mono-anti-HLX10 adopted a differentiated "Combo-Global" (joint therapy and internationalization) development strategyAt present, Fuhong Hanxuan in the United Nations, the top clinical oncology experts, around HLX10 has carried out more than 10 clinical studies, widely covered lung cancer, stomach cancer, hepatocellular carcinoma, esophageal cancer, head and neck cancer and cervical cancer and other major cancers, and in the simultaneous clinical exploration of single-drug treatment of chronic hepatitis B, in the number of key clinical trials (Pivotal trialal) in the domestic anti-PD-1 single-level leadershipit is worth mentioning that HLX10 clinical research on MSI-H/dMMR (highly microsatellite instability/mismatch repair defects) solid tumor has entered phase 2, this study is not based on the traditional tumor primary lesions and pathological type screening of patients, but according to tumor marker characteristics, as long as the tumor marker MSI-H/dMMR status is positive and first-line standard treatment failure, meet the clinical trial discharge standards of solid tumor patients can be included in the studySuch experimental design conforms to the advanced concept of accurate treatment of tumors according to the characteristics of markers, covering a wide range of cancer speciesIf the results of the study meet certain requirements, Fuhong Hanxuan is expected to use this phase 2 trial data this year to list the HLX10In addition to the declared potential of this Phase 2 clinical study, a number of HLX10 combination therapies have progressed to critical phase 2/3 phases of clinical studies for different indicationsCombo: Indications choose to focus on differentiation, a large number of key studies
In addition to the above-mentioned phase 2 clinical study for MSI-H/dMMR solid tumor completed the first patient administration, HLX10 single-drug treatment of chronic hepatitis B phase 2 clinical study has also completed the first patient administrationin order to improve the efficacy of PD-1 drugs, Fuhong Hanjun, with its own rich tumor treatment product pipeline, actively explore HLX10 and its own portfolio of immuno-combination therapiesAt present, Fuhong Hanxuan is actively promoting a total of 8 HLX10 immunotherapy clinical trials for different solid tumorsAmong them, HLX10 and its own single anti-HLX04 (beval pearl monobiotic similar to drugs), HLX07 (anti-EGFR monoantigen) and other composed of single anti-immune combination therapy is particularly worthy of attentionHLX10 joint treatment program for HLX004 is the first domestic mono-anti-combination therapy approved by IND, clinical trials for first-line non-squamous non-small cell lung cancer have entered the critical clinical phase 3The study was innovative, drawing on design highlights from internationally related clinical trials, and a three-arm clinical study designed to compare the efficacy and safety of HLX10 combination chemotherapy, HLX10-HLX04 combined chemotherapy and single chemotherapyHLX10 joint HLX04 clinical trials for second-line liver cancer have also entered the clinical phase 2, the domestic exploration of immunocheckpoint inhibitors in the population of the study of combined antiangiogenic drug treatment effect is less, the progress of this study is currently in the leading domestic levelin addition to monoimmune combination therapy, HLX10 combined with different chemotherapy regimens for esophageal cancer, small cell lung cancer, squamous non-small cell lung cancer and stomach cancer 4 clinical studies have also progressed to the critical clinical stage 3Among them, the exploration of HLX10 combined chemotherapy in gastric cancer focuses on the field of new assisted/assisted therapy, and pD-1 inhibitors are less explored in this fieldFu Honghanxuan earlier in this segmentof indications to carry out clinical research, and strive to promote research progress, and strive to enable early patients with stomach cancer can also benefit from tumor immunotherapy In addition, anti-PD-1 mono-anti-combination chemotherapy for cervical cancer phase 2 clinical study has also completed the first patient administration, clinical progress in the first echelon in the country the combination of the rapy, relying on the company has established a sound dual-specific antibody research and development platform, HLX10 research and development process accumulated PD-(L) 1 pathway mechanism, drug-effect structure and other aspects of data and experience, but also for the development of PD-1 and other target combination of bi-specific antibodies to lay the foundation Global: International quality is widely recognized, and actively explore overseas markets
HLX10's research and development in strict accordance with international standards, the production base of the product has been the European Union quality rights holder review At present, HLX10 has obtained clinical trial approval from the United States and Taiwan in the United States and Taiwan, in addition to the approval of clinical trials in the Chinese mainland In the clinical trials already under way in the HLX10, there are several international multicenter clinical trials, demonstrating the company's full confidence in the international quality of HLX10 Going to overseas markets such as the U.S and benefiting patients around the world will also be the key differentiated advantages and bright spots for HLX10 in the future at the 2019 National Conference of Clinical Oncology (CSCO) and the 2019 European Society for Oncology (ESMO) Annual Meeting in Asia, Fu Honghan shared a new study of a Phase 1 clinical trial (NCT02644490) for evaluating the efficacy and safety of HLX10 in patients with advanced solid tumors, which showed good tolerance in Stage 1 patients and hlX10 monodrug therapy in patients with multiple solid tumors Good Stage 1 clinical performance, as well as excellent PK and PD data from preclinical studies, laid the foundation for supporting the smooth development of late-clinical trials HLX10 as an innovative anti-PD-1 monoantigen, its clinical trial is exploratory research, need to constantly explore different dosages, drug use methods, adverse reactions, etc , the clinical team has high requirements HLX10 clinical trials are conducted by well-known oncologists in China as key researchers, leading a professional and authoritative and experienced clinical team In addition, the design of the pilot scheme is also one of the key factors affecting the success or failure of the study The company draws on the advantages and experience of previous PD-1 inhibitor clinical trial programs, and actively explores the application of biomarkers in tumor immunotherapy, and optimizes and upgrades the experimental design The design of HLX10-related clinical trial programs has not only been unanimously endorsed by domestic clinical oncologists, but also received positive feedback from the FDA in the communication prior to clinical trials accelerate the pace of HLX10 international multi-center clinical research and enter the mainstream market, Fuhong Hanxuan also seized the opportunity to benefit more patients around the world, especially in emerging markets through international cooperation Fuhong has reached a partnership with PT Kalbe Genexine Biologics (KG Bio) to grant it exclusive rights to develop and commercialize HLX10's first single-drug therapy and two combination therapies in 10 countries in Southeast Asia Starting in Southeast Asia, Fuhong Hanjun will continue to expand the HLX10's presence in emerging markets In the future, if the relevant clinical research of HLX10 is going well, the comprehensive demand of domestic and foreign markets is expected to further enhance the economies of scale in the production of HLX10, so that the HLX10 has sufficient cost advantages Fuhong Hanxuan around HLX10 "Combo-Global" strategy in the segmentation of indications and market-wide differentiation advantages are significant, single-drug and a number of joint treatment programs have entered the key clinical research phase with declared potential, for a number of indications clinical progress are in the domestic anti-PD-1 mono-clinical research and development of the leading level In the future, we hope that HLX10 clinical research and development at home and abroad will go smoothly, so that patients in China and around the world can bring more affordable high-quality cancer immunotherapy programs original title: Fuhong Hanxuan anti-PD-1 monoantigen - Multiple indications into the critical stage of clinical stage, Combo-Global differentiation clear