Significant progresses in IND, clinical development, NDA/BLA, commercialization, BD and financing
- NDA/BLA progress - GB226 (Geptanolimab) Priority Review for PTCL, GB242 (infliximab (Remicade) biosimilar) under Review
- Clinical development – Three products' registrational pivotal trails completed (GB226，GB221，GB242), GB491 (CDK 4/6) for 1L and 2L HR+/HER2- breast cancer bridging studies EC approved, GB261 first in human (FIH) trial EC submitted in Australia in March-21
- IND progress - Eight IND applications approved and two under reviews, three bispecific assets entering into IND enabling stage
- Commercialization - Key commercial personnels on board preparing for the new drug launch, Investment agreement with China (Shanghai) Pilot Free Trade Zone Lin-Gang Special Area Administration
- Active BD - In-licensed GB491 (CDK4/6) for the treatment of HR+/HER2- breast cancer from G1 Therapeutics, and GB492 (STING agonist) from ImmuneSensor Therapeutics
- Success financing - Received B-round financing of US$160mn in May, successfully raised US$400mn and listed on the main board of HKEX in October
- GB261 (CD20/CD3) – First Patient Enrollment in Australia in Q321, and initial POC Data in 1H22
- GB491 (Lerociclib)(cyclin-dependent kinase, CDK4/6) – First Patient Enrollment for Phase 3 trial for 1L /2L HR+/HER2- mBC in Q421, and Interim Analysis for 2L HR+/HER2- mBC in 2Q23
- GB226 (Geptanolimab) – NDA approval for r/r PTCL, Q321
- GB242 (TNF-ɑ, Infliximab biosimilar) – NDA approval, 1H22
SHANGHAI, CHINA - Media OutReach - 26 March 2021 - Genor Biopharma (Stock code: 6998.HK) announced today its 2020 annual results to share the company's financial results, business progress and other highlights in the reporting period.
The year 2020 is a year for Genor Biopharma to accumulate and develop rapidly and forge ahead with determination. During this year, the company has made significant progress in clinical trials, pipeline development, commercialization preparation, manufacturing and other aspects.
Our mission is to become a biopharmaceutical engine in discovery, research, development, manufacturing and commercialization of innovative therapeutics initially for patients in China and gradually for patients globally. We strive to build up a world-class China-based innovative biopharmaceutical company through its integrated biopharmaceutical platform. To achieve this mission, Genor Biopharma will continue to expand our innovative pipeline to address more attractive and unmet medical needs in China and globally and at the same time to maximize existing portfolio by developing and executing comprehensive strategy.
Rapidly advance the Group's novel bispecific/tri-specific pipeline candidates into clinical stages
Genor Biopharma will continue to focus on developing our early-stage innovative pipeline from our two research hubs in Shanghai and in San Francisco (Ab Therapeutics Inc.) by applying licensed cutting-edge bispecific and multi-specific antibody discovery platforms to in silicon design and to bench engineer novel and highly differentiated bispecific and tri-specific therapeutic antibody candidates targeting cancers in order to match unmet clinical needs.
Currently, we have multiple bi-specific and tri-specific antibody drug candidates, the highlights among which include candidates targeting CD20/CD3(GB261), PD-L1/CD55(GB262), EGFR/c-Met/c-Met(GB263T), and Claudin 18.2/CD3(GB264), none of which currently have approved drugs worldwide. We have submitted four abstracts for 2021 AACR in February 2021, and all of them have been accepted as "Late Breaking Abstracts".
Moreover, benefiting from years of experience in biologics development, we have rapidly expanded our CMC capabilities from monoclonal antibody technologies to a bispecific and multi-specific antibody platform, ranging from cell line development, bioprocess development, and analytical development. After the lead selection of GB261 at the end of 2019, Genor Biopharma had accomplished the IND-enabling works over the past 16 months, which included cell Line and cell culture development, purification development, formulation development, analytical methods development, GLP Tox Lot and Clinical Lot manufacturing and release, BsAb structural and functional characterization, ICH-compliance stability studies startup, and completed GLP toxicity studies, clinical protocol drafting, CTA dossier preparation, etc. together with medical, registration and other teams.
The company have submitted our first-in-human clinical trial application of GB261 (CD20/CD3 bi-specific antibody) in patients with B-cell non-Hodgkin Lymphoma (B-NHL) in Australia in March 2021. And we plan to file Investigation New Drug (IND) applications with the NMPA and the FDA and advance these antibody drug candidates into the clinical stage in 6 to 12 months. The global development of GB261 will also lay the foundation for the global clinical development of subsequent antibody candidates and other innovative drugs.
Expedite regulatory approval of the Group's lead product candidates
Genor Biopharma expects to launch Geptanolimab (GB226) at Q3 this year, it is the first PD-1 inhibitor worldwide for peripheral T-cell lymphoma (PTCL) and is expected to bring safe and high-quality therapeutic benefits to patients. And we will continue to explore approval for Geptanolimab (GB226) in other indications as well as novel combination therapy potential, including IND filing for combination therapy with our STING agonist (GB492), to benefit more patients in China with unmet medical need.
In addition, Genor Biopharma has received IND approvals from the NMPA and the Ethic Committee approves for two Phase 1b bridging studies: (1) GB491 (Lerociclib)(cyclin-dependent kinase, CDK4/6) and Letrozole in first line HR+/HER2- advanced breast cancer; and (2) GB491 (Lerociclib) and Fulvestrant in second line HR+/HER2- advanced breast cancer in March 2021.
IND application of GB492 (IMSA101, Stimulator of interferon genes，STING) is under review by NMPA. The Phase I/IIa clinical trials will evaluate the safety and efficacy of GB492 as monotherapy and in combination with recombinant anti-human PD-1/L1 functional monoclonal antibody, in patients with advanced treatment-refractory malignancies.
Infliximab biosimilar (GB242) for autoimmune disease treatment is expected to be launch at 1H 2022, upon approval of NDA that are currently under review of NMPA.
Regarding key drug candidates in our portfolio treating breast cancer, we plan to file NDA to NMPA for Coprelotamab (GB221) in HER2+ breast cancer at Q4 of 2021.
Strengthen the leadership team and make comprehensive preparation for commercialization
Currently, the core management team members of the Group have more than 15 years of industry experience on average with a proven track record and a well-balanced combination of expertise spanning research and discovery, clinical development, manufacturing, regulatory affairs, commercialization and financing.
Dr. HAN Shuhua joined us as the Chief Scientist of the Group in January 2021. Dr. Han, with over 25 years' experience in drug discovery and academic research in the fields of immunology, cancer immunotherapy, oncology, autoimmune diseases and inflammation, will lead the company's in-house research and discovery efforts and accelerate our footprint towards building a world-class innovation engine.
Mr. CHEN Wende joined us as Chief Operation Officer in July 2020. With over 20 years of experience in biopharmaceutical industry, Mr. Chen will lead the commercial operation of the company.
In preparation for the new drug launch, the Company is steadily building up our commercialization team，and developing commercial strategy to support GB226 launch in 2021 and other new product launches in the future successfully. Currently, key commercial people have been on-board.
In December 2020, our commercial team has participated in the 2020 annual conference of China Cancer Prevention and Treatment League and promoted the Company and GB226 r/r PTCL studies among medical society. And meanwhile, the commercial team has been working closely with key stakeholders for pharmacoeconomics (PE) study for GB226 in preparation for the product launch and participations of National Reimbursement Drug List ("NRDL") negotiation.
Our manufacturing facility in Yuxi, Yunnan province has completed and successfully passed the On-Site Production Inspection & GMP Compliance Inspection for GB226 NDA in November 2020. To support the commercial production of GB226 and more innovative drugs, the company signed an investment agreement with China (Shanghai) Pilot Free Trade Zone Lin-Gang Special Area Administration to build a commercial manufacturing facility with over 43,000 sqm in Shanghai Lin Gang Special Area in February 2021
- Total revenue was RMB10.3 million for the Reporting Period, primarily generated by providing research and manufacturing services to our customers under fee-for-service contract.
- Research and development expenses were RMB696.6 million for the Reporting Period, as compared with RMB438.8 million for the year ended 31 December 2019. The spending was mainly attributable to (i) the increase of our ongoing clinical trials expenses and (ii) our employee salary and related benefit costs
- Total comprehensive loss was RMB3,032.8 million for the Reporting Period, as compared with RMB523.0 million for the year ended 31 December 2019 primarily because under the Hong Kong Financial Reporting Standards("HKFRS"), the Group recorded a non-recurring loss of 1,933.8 million on net fair value losses on Preferred Share upon their conversion to ordinary shares at the Company's initial public offering ("IPO").
- Under Non-HKFRS measures, our adjusted loss(1) for the year was RMB654.6 million for the Reporting Period.
Adjusted net loss is calculated as loss for the reporting period excluding (i) fair value losses on Preferred Shares, (ii) share-based payment expenses, (iii) net foreign currency exchange losses and (iv) listing expenses.
About Genor Biopharma
Founded in 2007, Genor Biopharma Co. Ltd (Genor Biopharma, Stock code: 6998.HK) is an innovative biopharma company with a pipeline of therapies covering the world's top oncology areas (breast, lung, and gastrointestinal cancer).
Genor Biopharma is creating a fully integrated and end-to-end biopharma innovation company based in China, with global reach. In San Francisco, the cutting-edge bispecific and multi-specific discovery platform (Antibody Therapeutics Inc.) engineers novel and highly differentiated therapeutic antibody candidates with display technology, computer-aided design, and site mutagenesis. The industry leading R&D center located in Shanghai focuses on CMC (Chemistry, Manufacturing and Controls) development. This center is capable of developing comprehensive bioprocesses and formulations, and manufacturing preclinical and clinical materials with advanced analytical, quality control, and quality assurance systems for compliance. In 2016, the GMP commercial manufacturing facility was built and commissioned in Yuxi, Yunan and is currently operating with a highly GMP compliant production team. This commercial facility employs advanced continuous-flow cell culture technologies for high yield manufacturing (~20 g/L) as well as internally-developed cell culture media for cost-effective production. The site produces Phase III and pivotal trial clinical supplies, executes the commercial process validation, and performs the commercial manufacturing after product launch.
Genor Biopharma currently has 10+ drug candidates under development in clinical or New Drug Application (NDA) stages. Among them, the NDA for Geptanolimab (GB226) has been granted for priority review by the Center for Drug Evaluation (CDE) and has successfully passed the NDA pre-approval inspection by the National Medical Products Administration (NMPA), with a product launch targeted for 2021. It is the first PD-1 inhibitor worldwide for peripheral T-cell lymphoma (PTCL) and is expected to bring safe and high-quality therapeutic benefits to patients. The NDA filing for Infliximab (GB242) has also been accepted by CDE and is currently under review by the agency.