Shanghai, China, March 31, 2022 - Genor Biopharma (Stock code: 6998.HK) announced today its 2021 annual financial results, business progress and other highlights in the past year.
Up to now, Genor Biopharma has achieved the successful approval of GB242 (infliximab) was realized and the product will be commercialized with more NDA applications on the way. Successfully optimized its product pipeline and accelerated key clinical trials; established a global first-in-class/differentiated research and development platform for early identification of bi-specific/multi-specific antibodies in immune-oncology; started its journey of FIC/BIC R&D; and vigorously promoted global innovation and business development.
Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, Genor Biopharma said: “Genor Biopharma has set clear planning goals and developed strategic plan for the next four years. It has carried out the enrichment of innovative pipelines, the efficient acceleration of FIC/BIC R&D pipelines worldwide, the acceleration of clinical trials, the successful approval and commercialization of a number of products, and external business developments. Relying on excellent execution and close cross - departmental cooperation, the company will continue to create remarkable achievements.”
Specifically, Genor Biopharma will strive to achieve the following goals in 2022:
- Successful commercial promotion of GB242 (infliximab). In addition to the NDA approval of geptanolimab (GB226) for r/r PTCL, put continuous effort in seeking NDA submission for GB226 in additional indications and potential of new combination therapy.
- Continue to accelerate key projects, including the phase 1 clinical trial and preliminary Proof of Concept (POC) of the STING agonist (GB492) with GB226； and GB491 (CDK4/6) phase 3 trial for 1L/2L HR+/HER2- mBC
- Continue to develop several bi-specific and multi-specific antibody drug candidates. The IND application of GB261 and GB263T was accepted by the NMPA on March 18, 2022 and March 28, 2022. It plans to promote the phase 1 clinical trial and Clinical Proof of Concept (“POC”) of GB261 and GB263T.
- Conduct the multi-dimensional innovation and exploration of FIC/BIC potential based on the in-depth understanding of target molecular biology, cell biology and immunological mechanisms. As far, five FIC/BIC discovery projects of bi-specific/multi-specific antibody molecules were initiated. GB267 project has been established and IND-enabling, and the IND application of at least one self-developed FIC/BIC potential drug candidate will be submitted from 2023 and annually afterward.
- Achieve the strategic collaboration with a mRNA tech company for the discovery of novel mRNA therapeutics in cancer immunotherapy.
The successful approval of the first product has been realized and will soon be commercialized, with more product approvals on the way.
GB242 (Infliximab, biosimilar to Remicade, Jiayoujian佳佑健®) On February 23, 2022, the Company received NDA approval from the National Medical Products Administration (NMPA) for GB242 in the treatment of Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriasis, Adult Ulcerative Colitis, Adult and Pediatric Crohn’s Disease and Fistulising Crohn’s Disease. The company have been prepared for the upcoming commercial launch of GB242.
GB226 (Geptanolimab, Aibining 艾比寧®) The NDA for Geptanolimab (GB226) was officially accepted by the National Medical Products Administration (NMPA) and granted for priority review by the Center for Drug Evaluation (CDE), and successfully passed the NDA pre-approval inspection by the National Medical Products Administration (NMPA).
Accelerate multiple key clinical trials
Relying on the in-depth expertise and close cooperation of all cross-functional teams, Genor Biopharma accelerated IND application, and clinical trial progresses.
GB491 (CDK4/6 inhibitor) – The company is devoted to provide breast cancer patients an efficacious CDK4/6 inhibitor with better safety profile.
GB491 (Lerociclib) is a novel, potent, selective oral CDK4/6 inhibitor combined with endocrine therapy for the treatment of breast cancer patients. Based on data published at the European Society for Medical Oncology 2020 conference, GB491 has demonstrated a better safety and tolerance profile, enables continuous daily administration with better long-term benefits, and could potentially become a best-in-class CDK4/6 drug candidate.
In May 2021, IND applications for two Phase 3 clinical trials of GB491 were submitted to the NMPA by the Group: (1) in combination with Letrozole in first-line HR+/HER2- advanced breast cancer, and (2) in combination with Fulvestrant in second-line HR+/ HER2- advanced breast cancer，and approval obtained in July 2022.
- The products were proved to have no ethnic difference with sufficient clinical data and successfully exempted from the bridging study. As such, the products could enter into a phase 3 clinical trial earlier than scheduled. The phase 3 clinical trial of GB491 and Fulvestrant in second-line HR +/HER2- was approved by the EC in June 2021, and the first patient was dosed in October 2021. The clinical trial is accelerated.
- Leveraging the safety lead-in stduy design, the 1L phase 3 clinical trial was carried out seamlessly and was accelerated. The phase 3 clinical trial in first-line HR+/ HER2- was approved by the EC in August 2021, and the first patient was dosed in January 2022.
- The phase 3 trials for the first and second line were continuously accelerated via an adaptive and seamless study design, scientific-based data leveraging and bridging, a seamless registration strategy, and excellent execution.
The Company’s CMC and project management team solved various CDMO technical and communication problems across countries and regions through collaboration with four CDMOs in China, Europe and the United States, ensuring strict compliance with relevant regulations in each country/region. API, clinical supplies of GB491 and placebos were successfully produced within one year to supply for phase 3 study, guaranteeing the efficient implementation of projects.
GB492 (IMSA101, STimulator of interferon genes, STING Agonist)
GB492 (IMSA101) is the major mediator of innate immune sensing of cancerous cells. Multiple studies have shown that STING agonists can activate cGAS-STING signaling and significantly enhance the efficacy of the cancer immunity cycle when used in combination with other immune checkpoint inhibitors (ICI). It has the potential to become a first-in-class therapy.
In March 2021, Genor Biopharma submitted an IND application to the NMPA for the Phase 1 clinical trial of GB492 as a monotherapy or in combination with GB226 in patients with advanced/treatment-refractory malignancies. The company received IND approval in May and EC approval in July. In September 2021, the first patient was dosed in the Phase 1 clinical trial of GB492 in China and the monotherapy first-dose group (400ug) was completed in Jan. 2022.
An innovative FIH trial design was employed to combine the dose escalations when GB492 is administered alone and when it is administered with GB226 in one FIH study. It is the first STING agonist combination therapy to obtain clinical trial approval in the country. In January 2022, GB492 successfully obtained the approval from the Center for Drug Evaluation (CDE), waived mono dose escalation and directly entered the dose escalation phase with PD-1.
GB261 (CD20/CD3, bi-specific antibody)
GB261 (CD20/CD3) is a novel bi-specific antibody targeting CD20 and CD3 developed in-house. It is the first T-cell engager with low affinity to bind CD3 and enables Fc functions (ADCC and CDC).
In March 2021, Genor Biopharma submitted a clinical trial application to the Bellberry Human Research Ethics Committee (HREC) in Australia for an FIH clinical trial of GB261(CD20/CD3). The IND application of GB261 was accepted by the NMPA on March 18, 2022.
Leveraging the differentiated product features, the starting dose of the GB261 clinical trial was selected to be higher than the compounds in the same class, still ensuring safety while preventing patients from exposure to invalid doses. As such, the effectiveness of dose escalation was improved significantly.
The first dose group has been completed. The data showed that the T1/2 of this product exceeded one week, indicating that GB261 was safe at the relatively high starting dose with no CRS. This was in line with the product’s designed features, pre-clinical features and differentiated features.
GB263T (EGFR/cMET/cMET, tri-specific antibody)
GB263T is a highly differentiated EGFR/cMET/cMET tri-specific antibody targeting EGFR and two different epitopes of cMET.
Genor Biopharma submitted a clinical trial application to the Bellberry Human Research Ethics Committee (HREC) in Australia in December 2021 for the FIH clinical trial of GB263T, and got the EC approval on March 28, 2022. Meanwhile, China IND application was officially accepted by the NMPA on March 28, 2022.
The research and development of GB263T fully demonstrated the advantages of cross-team collaboration and helped to expand the organization’s international capabilities and reach. Working closely with globally renowned KOLs, the clinical trial protocol was finalized on the date of obtaining the toxicology data, substantially speeding up submission to the EC.
Benefiting from the powerful strength and fast-moving execution ability of the Group’s CMC, the process technology development, toxicology study & clinical study drug manufacturing and clinical trial application of GB263T were completed within only twelve months in compliance with international standards. This was much faster than the industry average. Moreover, the excellent process performance and product quality were ensured with a high expression level of 5-6g/L and high purity of 99.5%.
Research and development of global innovative new drugs
During the Reporting Period, the Group established a global first-in-class / differentiated research and development platform for the early identification of bi-specific / multi-specific antibodies in immune-oncology, which continues to aim at addressing unmet medical needs and focuses on developing targeted antibodies and projects with FIC/BIC potential. The core R&D team with nearly 30-member is equipped with a new drug research and development capability and integrated pre-clinical study platform that range from the discovery of innovative antibody molecules to IND submission.
The company’s antibody discovery R&D team have established many capabilities including antibody screen, affinity measurement, epitope analysis and multi-target stably transfected cell lines, ensuring highly efficient and high quality drug discovery. The innovation and exploration of FIC/BIC potential have been conducted in multiple dimensions based on the in-depth understanding of target biology, cell biology and immunological mechanisms. Besides launching several novel antibody projects, the Company has actively pursued for different drug modalities to rich its pipeline.
Attract Senior Management Talents and actively expand global innovation
Genor Biopharma further strengthened its core management team in 2021. In January 2021, Dr. Han Shuhua joined the Group as Chief Scientific Officer. Dr. Han has over 25 years’ experience in academic research and new drug research and development, especially in the fields of tumor immunity, inflammation and autoimmune diseases. Prior to joining the Group, Dr. Han served as a tenured professor in immunology and pathology at the Baylor College of Medicine in the United States and recorded vast achievements during her tenure. Dr. Han's participation led the company to quickly establish its innovative R&D platform and initiate multiple FIC/BIC potential projects..
In October 2021, Mr. Liang Qibin joined Genor Biopharma as Chief Technology Officer. An experienced expert in the international biotechnology industry, Mr. Liang has nearly 30 years of involvement in the operation and management in the CMC and production departments of internationally renowned biopharmaceutical companies. As part of the positive effect on further strengthening the innovation ability of core technologies, Mr. Liang has led his team to achieve efficient innovation in technology, research and development, processes, management and other areas.
To expand global innovation, Genor Biopharma was honored to invite New SAB Members from China, the United States, the United Kingdom and Australia, who have vast experience in tumor immunology and oncology clinical research, and have globally recognized academic status. (Namely Dr. Alex A. Adjei, Dr. Zhijian Chen, Dr. Yangxin Fu, Dr. David Kerr CBE, Dr. Leonard Saltz, Dr. John F. Seymour AM and Dr. John R. Zalcberg OAM.)
The participation of the world’s top scientists reflects their high recognition of the Company’s research and development philosophy, scientific research strength and continuous exploration. Their participation will accelerate the pace of Genor Biopharma’s global innovation, provide valuable input on Genor’s FIC and BIC projects and differentiated pipelines, and support the rapid advance of candidate drugs into clinical development in China, the United States, Australia and Europe.
- Research and development expenses were RMB612.7 million for the Reporting Period. The spending was mainly attributable to (i) new drugs development fee and ongoing clinical trials expenses and (ii) employee salary and related benefit costs.
- Total comprehensive loss was RMB865.8 million for the Reporting Period, as compared with a comprehensive loss of RMB3,032.8 million for the year ended December 31, 2020, primarily because under the Hong Kong Financial Reporting Standards (HKFRS), the Group recorded a non-recurring loss of RMB1,933.8 million on net fair value losses on preferred shares upon their conversion to ordinary shares at the Company’s initial public offering (“IPO”) for the year ended December 31, 2020.
- Under Non-HKFRS measures, the adjusted loss (1) was RMB702.8 million for the Reporting Period, as compared with RMB654.6 million for the year ended December 31,2020.
(1) Adjusted loss is calculated as loss for the years of 2021 and 2020 excluding (i) fair value losses on preferred shares, (ii) share-based payment expenses, (iii) net foreign currency exchange losses and (iv) listing expenses.