Mr. Fu, Shan, Chairman of TOT BIOPHARM, said “TOT BIOPHARM was listed on the Main Board of The Stock Exchange of Hong Kong Limited on 8 November, 2019, officially entering a new stage of internationalization and rapid development. We have gained access to more financing channels which are conducive to the acceleration of various operations of the Company. Leveraging its leading technological innovation capability, the Company’s Research and development (R&D) projects are progressing as scheduled during the year. Highlights here include completion of patient enrolment for the Phase III clinical trial of TAB008 (a bevacizumab biosimilar for the treatment of non-squamous non-small-cell lung cancer). In addition, Phase I clinical data of TAA013 (HER2+ breast cancer), our self-developed ADC drug, was published during the year, the first T-DM1 ADC product to release this data in the Chinese market. We are encouraged that our TAB014 (An anti-VEGF Monoclonal Antibody for the Treatment of wet age-related macular degeneration) was recognized as a special major project for technologies of “innovative manufacturing of major new drugs” of China. Moreover, we have commenced diversified strategic cooperation with domestic and international companies, to accelerate the progress of major R&D projects and achieve income growth.”
FINANCIAL HIGHLIGHTS (as at 31 December 2019)
Hong Kong Financial Reporting Standards Measures:
– Revenue amounted to RMB45.3 million, representing a 16% year-on-year increase, mainly attributable to diversified revenue sources such as CMO and CDMO service fees as well as commissions for marketing services provided.
– Research and development expenses amounted to RMB191.1 million, representing a 1% year-on-year increase.
– Net loss amounted to RMB299.3 million, representing a 12% year-on-year increase mainly due to listing expenses.
Since its inception in 2009, the Company has built and established a “two-chain four-platform” system: Two-chains: a complete industrial value chain as well as a high-quality and diversified product chain; Four-platforms: Innovative technology platform, high-standard commercial production platform, clinical research platform, marketing and business platform. The integrated operation of each value chain and platform exhibits the greatest synergy. The Company’s comprehensive product pipeline consists of seven biological and five chemical drug candidates, 11 of which are self-developed.
The operations of the Company’s various R&D pipelines proceeded hand-in-hand during the year and achieved smooth progress with the following major milestones.
– TOZ309: A generic drug candidate of temozolomide capsules, which is a chemical drug for the treatment of malignant brain gliomas. ANDA was submitted in July 2019. It is expected to be filed in 2020.
– TOM218: ANDA was submitted and accepted for filing.
The progress of clinical stage products
– TAB008 (a bevacizumab biosimilar for the treatment of non-squamous non-small-cell lung cancer): The Company’s most advanced biological drug candidate. Patient enrollment for Phase III clinical trial of the drug was completed in 2019 as scheduled. It is currently preparing the NDA submission. The drug is expected to be approved for launch at the end of 2020 or early 2021.
– TAA013: An ADC candidate containing trastuzumabemtansine (Trastuzumab-MCC-DM1) aiming to become an affordable alternative of Kadcyla, is used for the treatment of breast cancer. The Phase I clinical data was published in 2019, which was also the first T-DM1 ADC product in the Chinese market to release this data. The Company plans to carry out Phase III clinical study in 2020 and expects to complete the Phase III clinical trial by the end of 2022 and launch the drug in 2023.
– TAB014: (A drug developed based on bevacizumab) For the treatment of disease related to retinal neovascularization, such as wet age-related macular degeneration (wAMD). It was recognized as a special major project for technologies of “innovative manufacturing of major new drugs” of China. TAB014 is in Phase I clinical trial. It is expected to complete Phase III clinical trial by 2022 and launch in 2023. The US FDA pre-IND regulatory consultation was completed during the year.
The R&D of other drugs continues to result in product launches as scheduled.
Commercialization and production
Recently, TOT BIOPHARM has been increasing investments and has established an antibody drug production base with a designed production capacity of 16,000L, thereby forming a comprehensive and high-quality drug and product chain. The Company has also developed Perfusion-Batch Hybrid Technology (“PB-Hybrid Technology”), and was the first to apply this technology to commercial-scale production in China and completed production and validation of various products and batches, thus creating a mature technology for its own utilization. The technology has disrupted the traditional processes of large-scale monoclonal antibody cell expansion. It can be expanded from 25L to 2000L directly without going through the 10L, 50L, 200L and 500L expansion steps, thereby streamlining process flows, optimizing product quality, shortening production cycles and reducing capital expenditures. This brings remarkable advantages to our production.
The Company has been engaged in the technology of antibody drug conjugates (ADC) for few years. It has already completed the R&D and trial production of ADC product TAA013, published the data of Phase I clinical trials and finished CDMO/ CMO of innovative ADC drugs with several partners. The Company is constructing the ADC drug production facility, and will be one of the few companies in China with a GMP-compliant ADCs commercial production plant, laying the foundation for the development of the ADC field. Through this experience the Company can have the advantage of quick entry into a market.
Diversified strategic cooperation
The Company takes advantage of its open platform to exploring collaborative opportunities internationally, thereby continuously enriching the Company’s product pipeline and enhancing innovation capabilities. The Company will continue to extend new indications of its drug candidates and to expand its market opportunities. The Company will also proactively seek for international strategic collaboration to jointly develop innovative products. In addition, by utilizing its exclusive advantages in production and technology, the Company has conducted new cooperation for CMO, CDMO with companies such as Miracogen, Kintor and NewBio.
Ms. Yeh-Huang, Chun-Ying, General Manager of TOT BIOPHARM, said, “Antibody-based drugs in the China market represent an enormous potential and we are ready to seize the huge market opportunities. We will continue to focus on the anti-tumour drugs segment and accelerate our R&D activities, focus on advancing the clinical research of drugs such as TAB008, TAA013 and TAB014, continue to launch products and further open up our businesses and platform and introduce different cooperative partners, thereby enriching our product pipeline and achieving diversified revenue sources. We will always adhere to our business philosophy of “Balance of Humanity and Technology”. We are committed to developing new anti-tumour drug products with high technological barriers and economic value, providing a suitable and affordable product portfolio, and creating value for our shareholders and society”.
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