TOT BIOPHARM Announces A Number of Key Anti-Tumor Drugs Have Entered the Pivotal Clinical Stage in 2020

Two Self-Developed Drugs Are Expected to be Approved for Marketing in 2021

HONG KONG, Mar 24, 2021 - (ACN Newswire) - TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Company"; stock code: 1875.HK), a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative oncology drugs and therapies, announced today its audited annual results for the year ended 31 December 2020.

Milestones of 2020 Annual Results
TOT BIOPHARM's core products including mAb drug TAB008 and ADC drug TAA013 have achieved key milestones. The Company actively promoted the development of and collaboration relating to innovative drugs and have established a R&D and commercialization platform integrating mAb and ADC drugs. The Company will rapidly expand its CDMO/CMO business to create new momentum for the future development of the Company.

Key milestones of pipeline products:
-- TAB008 (anti-VEGF mAb): Phase III clinical results were published. The clinical results show that TAB008 has similar efficacy, safety, immunogenicity and pharmacokinetics profiles with the brand-name formulation of bevacizumab. The new drug application under the new version of the Administrative Measures for Drug Registration was submitted, and was accepted by NMPA in September 2020 (Note: Pre-approval registration inspection was completed in January 2021). It is expected to be approved for marketing in 2021.
-- TAA013 (anti-HER2 ADC): It is the first T-DM1 ADC product entering Phase III clinical trial in China. The first participant was enrolled in July 2020. Clinical recruitment is progressing smoothly.
-- TAB014 (anti-VEGF mAb): Phase III clinical trial application (IND) was submitted to FDA. Upon receiving FDA's approval, it would be exempted from the Phase II clinical trial and would directly carry out Phase III clinical trial (Note: (IND authorized by FDA in January 2021, and would directly carry out Phase III clinical trial).
-- TOZ309 (temozolomide capsule): Pre-approval registration inspection was completed, and it is expected to be approved for marketing in the first half of 2021.

Key milestones of commercial production plans
-- In 2020, the construction of the ADC drug substance commercial production facility was completed, and the production of multiple batches of ADC drugs for clinical purposes was accomplished.
-- In 2020, the GMP compliance inspection of the production workshop for chemical drugs was completed, laying a foundation for the commercial production of chemical drugs.

Dr. Liu, Jun, Chief Executive officer, Chief Scientific Officer, and Executive Director of TOT BIOPHARM, said, "TOT BIOPHARM has achieved multiple targets during the year, and manifested more prominent competitive and it has gradually formed a trend of coordinated development for R&D and commercial production of innovative drugs. In 2020, our R&D achievements are encouraging! The core product TAB008, TOT BIOPHARM's Independently developed bevacizumab biosimilar, has been submitted new drug application under the new version of the Administrative Measures for Drug Registration, and has been accepted by NMPA. Moreover, ADC drug TAA013 has successfully entered Phase III clinical trial, with a leading position in China in terms of our R&D progress. In the meantime, TOT BIOPHARM has established a R&D and commercialization platform integrating monoclonal antibodies (mAb) and antibody drug conjugates (ADC). In short, medium and long-term development, we will continue to enhance its production capacity planning and expand its CDMO/CMO business, so as to meet international and domestic clinical and commercial needs, and create new momentum for the future development of the Company. 2021 will be a fruitful year for TOT BIOPHARM, our core products TAB008 and chemical drug TOZ309, are expected to be approved for marketing, thereby benefiting a large number of cancer patients. We will continue to commit on our corporate vision of improving the quality of life of cancer patients worldwide with innovative technologies through the unremitting efforts."

Unique Business Models
-- Our three integrated technology platforms and comprehensive industry chain
With three self-developed technology platforms and a complete international quality management system and registration team, TOT BIOPHARM has a comprehensive industry chain, covering from drug research and development, clinical research to commercial production, which lays a foundation for accelerating the progress of R&D, international market plan and CDMO business.
-- Abundant Product Pipeline
At present, we have 13 drug candidates, including biological drugs, TAB008 (anti-VEGF mAb), TAB014 (anti-VEGF mAb) and TAY018 (anti-CD47 mAb), and antibody drug conjugates (ADC), TAA013 (anti-HER2 ADC), which are indicated for various cancers with high incidence, such as non-small-cell lung cancer, breast cancer, gastric cancer, esophageal cancer and cervical cancer.
-- Commercial Production Layout with Competitive Edge
TOT BIOPHARM adheres to the business philosophy of the integration of innovative R&D and commercial production. The Company has a 16,000L capacity for mAb production and ADC drug substance production facility. In September 2020, the construction of drug substance production facility was completed for the commercial production of ADCs; the production workshop for chemical drugs has completed the GMP compliance inspection, which laid a foundation for the commercial production of chemical drugs.

The operations of the Company's various R&D pipelines proceeded hand-in-hand in 2020 and achieved smooth progress with the following major milestones.

Soon-to-be-commercialized Drugs
-- TAB008 (anti-VEGF mAb) (Non-squamous non-small-cell lung cancer (nsNSCLC)): The new drug application was submitted under the new version of the Administrative Measures for Drug Registration, and was accepted in September 2020. It is expected to be marketed in 2021.
-- TOZ309 (temozolomide capsules (200mg,100mg)): The temozolomide generic drug, a chemical drug, completed the pre-approval registration inspection, and it is expected to be marketed in the first half of 2021.
-- TOM312 (megestrol acetate): We have completed the commercial-scale formulation process validation through continuous technological optimization, and have successfully submitted the ANDA application in Taiwan.

Clinical Trial Progress and Achievement
-- TAA013 (anti-HER2 ADC) (HER2-positive breast cancer): Phase III clinical trials were initiated in June 2020 with the first patient enrolled in July, and it is currently at the stage of clinical recruitment. It is planned to be launch in the market in 2023.
-- TAB014 (anti-VEGF mAb) (wet age-related macular degeneration (wAMD)): We have completed the pivotal Phase III clinical trials and CDE consultation, and directly carried out the Phase III clinical trials exempting from the domestic Phase II clinical trials. At the same time, we submitted the investigational new drug (IND) in respect of the Phase III clinical trial application of TAB014, based on the data from the Phase I clinical trial of TAB014 conducted in China and relevant clinical literature data, this IND application is a direct application for authorization to conduct Phase III clinical trial (being exempted from Phase II clinical trial).
-- TIC318 (carboplatin) (epithelial-derived ovarian cancer, small cell lung cancer, head and neck squamous cell carcinoma, testicular tumors, malignant lymphoma, cervical cancer, bladder cancer and NSCLC): We have completed commercial-scale formulation process validation in the high active drug injection workshop.

Commercial Production and CDMO/CMO Strategic Collaboration
TOT BIOPHARM increased resource investment, actively promoted CDMO/CMO business, and developed diversified strategic collaboration with domestic and foreign pharmaceutical companies to provide customers with high-standard and high-quality CDMO/CMO services.
-- The Company's commercial production technology demonstrates a sharp competitive edge in cost effect. Its self-developed perfusion-batch combined process flows, PB-Hybrid Technology, can realize commercial production direct scale-up from 25L to 2,000L in the cell culture process, thereby streamlining process flows, reducing production risks while shortening production cycles, lowering production costs, and greatly improving production capacity and cost advantages.
-- For the year of 2020, the Company has reached commercial collaboration with several innovative pharmaceutical companies to provide CDMO/CMO services for new drug R&D partners, including the CDMO collaboration with Kintor Pharmaceutical Limited (9939.HK) to continue providing clinical supplies manufacture and technical support for its core product Proxalutamide in China and the United States. At the same time, we provide Kintor clinical supplies manufacture for the novel coronavirus disease (COVID-19) overseas (including the United States, Brazil, etc.), pursues diversified collaboration opportunities while increasing the Company's cash flows.

Future Development
Embrace openness and win-win collaboration to promote domestic and international
commercial collaboration for drug candidates: At present, TOT BIOPHARM has multiple product pipelines such as biological drugs, ADC drugs and chemical drugs, which are stepping into the commercial stage with huge market potential. TOT BIOPHARM has been adhering to the principle of openness, collaboration and win-win, and discusses future commercial development strategies with various domestic and foreign partners. Relying on R&D, clinical trials and a one-stop full industry chain platform of application, manufacturing and commercialization, TOT BIOPHARM actively seeks the strategic collaboration domestically and internationally. We will obtain milestone funds through the transfer of domestic and foreign sales rights. Through diversified collaboration models, we share resources, accelerate the progress of product R&D and marketing, and rapidly occupy domestic and foreign market shares to enhance market competitiveness. Leveraging our unique advantages in R&D and production, we strengthen CDMO/CMO business collaboration to provide pharmaceutical companies with production capacity and technological requirements which they are lack of, and help customers shorten production time and reduce production costs in a cost-effective manner.

Financial Highlights
-- Revenue amounted to RMB22,491,000, representing a 50% year-on-year decrease, mainly attributable to the impact of the national volume-based procurement policy on the sales derived from the distribution of brand-name drug S-1, and the alignment of our CDMO business with our customers' planned schedules.
-- Research and development expenses amounted to RMB235,196,000, representing a 23% year-on-year increase, mainly attributable to the commencement of Phase III clinical trial for the TAA013 project of the Company in 2020 after the completion of Phase I clinical trial that resulted in an increase in demand for active pharmaceutical ingredients (APIs), excipients and consumables by related contract research (CROs) and those for the preparation of clinical drugs.
-- Selling expenses amounted to RMB25,953,000, representing a 18% year-on-year decrease, mainly attributable to the overall economic slowdown as a result of the outbreak of COVID-19 in 2020 which led to the suspension or postponement of various marketing events.
-- General and administrative expenses amounted to RMB46,855,000, representing a 51% year-on-year decrease, mainly attributable to the inclusion of listing expenses in the expenses for the same period in 2019.
-- In summary, net loss for the year of 2020 amounted to RMB288,498,000, representing a 4% year-on-year decrease.

About TOT BIOPHARM International Company Limited (Stock Code: 1875.HK)
TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumour drugs and therapies, striving to build a leading brand of oncology treatments worthy of the trust of patients and their families, and medical professionals.

The Company has in place three major integrated technology platforms. They are:

Therapeutic Monoclonal Antibody and ADC Technology Platform: it integrates research and development (R&D) and production capacities for antibody-based drugs and ADC, with the designed production capacity of the commercialization base of biological drugs reaching 16,000L to accommodate high-quality commercialization of drug candidates;

Gene Engineering Based Therapeutics Technology Platform: it integrates anti-tumour immunotherapy, gene therapy and viral therapy and pursues R&D and production of tumour-targeted oncolytic virus products;

Innovative Drug Delivery Technology Platform: a comprehensive platform for the process development and commercial production of high intensity and frequency of drug injections. It adopts a production design with aseptic lyophilization and aseptic filling to satisfy the GMP production requirement of OEB 4/5 active level lyophilized powder and water needle.

Using these platforms, the Company has studied and developed various anti-tumour drug series and genres, and has formed a high quality and comprehensive drug product chain. On top of developing innovative proprietary drugs, the Company also draws on its own industry value chain to build a complete industry chain platform that supports operations from R&D and production and clinical development to marketing. By adopting an open platform business model, it is able to cooperate with biomedical enterprises and third parties at different stages along its industry value chain.

For enquiries:
Strategic Financial Relations (China) Limited
Anita Cheung / Winnie Lau / Christina Chong / Tin Tim
Tel: (852) 2864 4827 / 2864 4876/ 2864 4899 / 2114 4907
Email: [email protected]



Source: TOT BIOPHARM International Company Limited

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