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TOT BIOPHARM Announces 2020 Interim Results

发布时间:2020-08-14

TOT BIOPHARM Announces 2020 Interim Results
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Accelerates Development for Upgrade

Focuses on the ADC Platform and Improves Competitiveness

 

(Hong Kong, 13 August 2020) 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 unaudited interim results for the six months ended 30 June 2020.

 

In the first half of 2020, in light of the robust development of China’s pharmaceutical industry and the fierce competition in the biopharmaceutical market, TOT BIOPHARM has accelerated its pace of strategic development, focused its resources on areas of strength and enhanced its innovation capabilities, while also strengthening its competitiveness in the field of antibody drug conjugate (“ADC”) products, thereby aspiring to be the leader in China’s ADC market. In which, TAB008 (a bevacizumab biosimilar for the treatment of non-squamous non-small-cell lung cancer) have been met primary endpoints in Phase III clinical trial. TOT BIOPHARM has successfully carried out Phase III clinical trial of TAA013 (for HER2+ breast cancer), a self-developed ADC drug. It is the first ADC product in China under the generic name (INN) of T-DM1 which demonstrates a competitive edge in the market. It also completed the first enrollment of patients for the clinical trial in July 2020. Moreover, TOT BIOPHARM has continuously enhanced diversified strategic cooperation with domestic and international companies continuously, to heighten CDMO and CMO businesses and achieve diversified cash flow.”

 

BUSINESS HIGHLIGHTS

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

 

Clinical Trial Progress

l   TAB008 (anti-VEGF mAb) (non-squamous non-small cell lung cancer (nsNSCLC)): As the TOT BIOPHARM’s most advanced biological drug candidate and core product, TAB008 has met the primary endpoints of its Phase III clinical trial being met and the new drug application (NDA) is soon to be filed.

l   TAA013 (anti-HER2 ADC) (HER2+ breast cancer): TOT BIOPHARM has successfully commenced the Phase III clinical trial of TAA013 and completed the dosing in the first patient for the clinical trial in July 2020.

l   TAB014 (anti-VEGF mAb) (wet age-related macular degeneration (wAMD)): In early 2020, the Phase III proposal was approved by the German medical regulatory body Paul Ehrlich Institute (PEI). We have also submitted our consultation on PRC regulations in relation to pivotal clinical trials to the National Center for Drug Evaluation (CDE).

 

The R&D of other drugs continues to result in product launches as scheduled.

 

Commercialization and production Progress

l   The Company has successfully produced multiple batches of medicine for the Phase III clinical trial of TAA013, an ADC product.

l   The Company has completed the infrastructure construction of the ADC drug substance production facility which will be put into use in September 2020.

 

Implementation of Strategies

l   Accelerating the launch processes of clinical-stage products;

l   Focusing on core strengths, diversifying the pipeline of ADC products, and improving innovation capabilities;

l   Fully opening up the R&D technology platform to foster collaboration among strong market players, thereby reducing the cost and risks of new drug development and accelerating the launch processes of new drugs;

l   Proactively expanding the CDMO/CMO businesses, strengthening project collaboration, and creating new resources of revenue growth;

l   Intensifying the recruitment and motivation of talents.

 

FINANCIAL HIGHLIGHTS (as at 30 June 2020)

Hong Kong Financial Reporting Standards Measures:

l   Revenue amounted to RMB13,030,000, representing a 47% 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 CDMO and CMO businesses with customers’ planned R&D schedules.

l   Research and development expenses amounted to RMB99,325,000, representing a 31% year-on-year increase, mainly attributable to the commencement of Phase III clinical trial for the TAA013 ADC project during the period soon after the completion of Phase I clinical trial.

l   Selling expenses amounted to RMB13,726,000, representing a 19% year-on-year decrease, mainly attributable to the suspension or postponement of various marketing events during the period as a result of COVID-19.

l   General and administrative expenses amounted to RMB24,118,000, representing a 31% year-on-year decrease, mainly attributable to the IPO related expenses incurred during the same period in 2019.

l   In summary, net loss for the period amounted to RMB129,183,000, representing a 12% year-on-year increase.

 

Future Development

Ms. Yeh-Huang, Chun-Ying, General Manager of TOT BIOPHARM, said, “In order to seize the opportunities of antibody-based drugs in the China market, we have upgraded our development strategies adequately and improving our R&D progress, strive to keep abreast of international frontiers, accelerate the R&D and commercialization of ADC drugs, and continue to diversify the product pipeline of ADC drugs as well as open its commercial production platform. The efforts will lay a solid foundation for TOT BIOPHARM to develop in the ADC field and seize market opportunities  as a first-mover. In the future, TOT BIOPHARM will continue to focus on anti-tumor drugs and give full play to our competitive edge. To prepare ourselves for the future launch of our products in terms of production capacity, we will increase the investment of resources in key fields, accelerate the R&D of ADC drugs and the Phase III clinical trial of existing drug candidate TAA013, focus on the commercialization of TAB008, TOZ309 and TOM312, speed up the construction of production facilities for ADC drug substance and agents andstep up the construction of platforms for oncolytic virus products and liposome drugs. While maintaining adequate production capacity for our current products, we will promote collaborative CDMO and CMO projects by leveraging our technology platform strengths and commercial production capabilities in mAbs, ADCs and small molecule chemical drugs. 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”.

 

 

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.