TOT BIOPHARM Anounces 2021 Interim Results

Revenue Surges 78% to RMB23.13 million
CDMO Business Achieves Leapfrog Breakthrough
Two Products Approved for Launch
Smooth Progress of Various Core Anti-tumor Drugs Clinical Trials
To Allocate Resources to Boost Innovative ADC Drugs

HONG KONG and SUZHOU, China, Aug. 13, 2021 /PRNewswire/ -- TOT BIOPHARM International Company Limited ("TOT BIOPHARM" or the "Group"; stock code: 1875.HK), a 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 2021.

KEY MILESTONES IN 2021 1H

In the first half of 2021, on the back of by national policies and driven by innovative R&D, the oncology drug market in China boomed and continued to gather growth momentum. The Group continued to implement its strategic plans drawing on its own strengths and competitive advantages, striving to become a leading player in the domestic ADC market. The Group speeded up R&D of ADC drugs and industrial planning and grasped market opportunities, enabling it to achieve breakthroughs in the realm of innovative drug CDMO/CMO.

Approval for Two Products Launching in the Market:

• TOZ309 (temozolomide capsules) was approved for launch in China by the NMPA in May 2021. It is a first-line medication for newly diagnosed and recurrent glioma as well as recurrent anaplastic astrocytoma. TOZ309 is the first self-developed chemical drug of TOT BIOPHARM. Together with other pharmaceutical companies in China to hasten market penetration of the product. It will at the same time prepare for renewal of the fourth round of drugs for centralized procurement in China in 2022.
• TOM218 (Megaxia® - megestrol acetate oral suspension) is imported by the Group, it owns the exclusive agency of the drug in mainland China, Hong Kong and Macau. The drug can alleviate the cachexia status of AIDS and cancer patients, including loss of appetite and body weight, and nausea and vomiting that sometimes occur. Compared to the solid dosage forms, oral suspensions can reduce the discomfort of patients in swallowing. Megaxia® had been approved for sale in the United States in 2014 and is the first high concentration megestrol acetate oral suspension approved for sale in China.

Major milestones of key products in clinical trial

• Core product TAB008 – Application for Marketing Approval Submitted and Being Processed: TAB008 is a bevacizumab biosimilar self-developed by TOT BIOPHARM for treating malignant tumors including advanced, metastatic and recurrent NSCLC and metastatic colorectal cancer. The new drug application (NDA) of TAB008 was filed in September 2020 and currently being processed by NMPA, which completed an on-site inspection and GMP-compliance inspection in January 2021. the Group expects to receive approval for marketing of the drug by end of 2021. As bevacizumab covers a number of cancers common in China, market demand would be huge.
• TAA013 – Smooth Progress of Phase III Clinical Trial: TAA013 is an ADC candidate containing trastuzumab and an emtansine derivative (Trastuzumab-MCC-DM1) for treating advance-stage or metastatic HER2+ breast cancer which could not be cured by trastuzumab and be surgically removed. In July 2020, the drug was given to the first patient in the Phase III clinical trial. To date, over 70 clinical research centers in the country are involved in the Phase III clinical trials making satisfactory progress.

Key milestones of commercial production planning

• In the first half of 2021, TOT BIOPHARM actively deployed for ADC pilot production and commercial production. It has put together highly competitive GMP-compliant pilot production facilities for mAb and ADC liquid formulation and drug substance, including the OEB-5 potency-level freeze-dried powder/liquid injection formulation (Capacity of ADC drug substance: 1g~300g/batch; Capacity of ADC formulation line: 500~5,000 vials/batch) and a GMP-compliant ADC commercial production workshop (Capacity of ADC drug substance: 1,000g~3,000g/batch; Capacity of ADC formulation line: 10,000~15,000 vials/batch).

Prominent Competitiveness of ADC Drugs

TOT BIOPHARM possesses core conjugation process technologies, a complete ADC analysis technology platform and independent analysis capabilities in respect of ADC critical metric attributes. Accordingly, we have achieved technical breakthroughs in the regulation of glycoforms, enabling precise control of the composition of each glycoform. It attributes to ensure the successful development of ADC processes and produce high quality of products.

TOT BIOPHARM has established an expert team for the R&D of conjugation process technologies of ADCs and an analysis team for complex ADC molecule structure. Boasting their extensive practical experience, successful exemplary cases and their comprehensive experience ranging from R&D, process development, clinical trials, registration and filing for approval to commercial production, and our products are at the leading position among ADCs in China.

CDMO/CMO BUSINESS ACHIEVES LEAPFROG BREAKTHROUGH

Devised One-stop Innovative Drug CDMO Solution

Despite the intense competition in the biomedical sector, TOT BIOPHARM has been able to effectively seize market opportunities and by giving full play to its open technological platform and commercial production capability, it has speeded up development of its "one-stop, localized" CDMO/CMO business, particularly in the ADC sector. It is able to capture first opportunities in the market and secure cooperation opportunities.

• TOT BIOPHARM owns core conjugation process technologies and has the ability to scale up technologies. With that advantage and capable of independent analysis of ADC critical metric attributes, the Group can guarantee the high quality of its product R&D work.
• It possesses "perfusion-batch hybrid technology" that can support commercial production of mAb drugs, including scaling up production from 25L to 2,000L directly, helping simplify the production process and shorten the production cycle, in turn enhance markedly the economic return of commercial CDMO/CMO projects.
• Priding long-term trusting relationship with partners, the Group took on various new CDMO/CMO projects in the first half of 2021, and saw substantial increase in terms of number of partners and business scale with the relevant revenue recording a substantial year-on-year growth of 330%.
• Being able to complete all the stages from R&D to putting out the end products in one plant and one place within the same production base at its Suzhou headquarter, TOT BIOPHARM managed to reduce much of the risks and difficulties in management, transportation and technological from outsourcing different procedures to different suppliers.

Strengthened Cooperation and Exchange

TOT BIOPHARM cherishes its long-term relationship and various kinds of cooperation with diverse partners and aiming to enhance core competitiveness of CDMO services.

• On 19 July, TOT BIOPHARM and BrightGene Bio-Medical Technology Co., Ltd. (688166.SH) became strategic cooperation partners, which has seen its one-stop for ADC drug CDMO service platform strengthen in favor of R&D and commercialization of innovative drugs. Pursuant to the agreement, the two parties will work together to provide clients with services starting with development of production craftsmanship, moving on to scaling up production and eventually GMP-compliant production. The cooperation realized seamless connection of industrial chains, removing the risks from cross-regional regulation, and is a marriage of strengths in terms of technologies and resources, allowing further upgrade of the CDMO service platform for ADC drugs to provide one-stop solutions to innovative drug corporations to help them reduce R&D risks and make commercialization more efficient.

CORE BUSINESS ADVANTAGES

TOT BIOPHARM has developed three core business advantages, providing a solid foundation for development of and cooperation in relation to innovative drugs.

• Three Technology Platforms and Comprehensive Industrial Value Chain

TOT BIOPHARM has three integrated technology platforms and a proven international quality Management and Registration System and registration team, plus a comprehensive industrial value chain that covers from R&D, process development, clinical trials, registration and filing to commercial production, giving it a solid foundation to speed up R&D, lay out international market presence and for its for its CDMO/CMO business.

• A Packed Product Pipeline with Huge Market Potential

At present, the Group has 12 drug candidates in the pipeline, including monoclonal antibody drugs such as TAB008 (anti-VEGF mAb), TAB014 (anti-VEGF mAb) and TAY018 (anti-CD47 mAb), and ADCs such as TAA013 (anti-HER2 ADC), for indications involving various high incidence cancers, such as non-small-cell lung cancer, breast cancer, gastric cancer, cerebral gliomas cancer and cervical cancer.

• Rare Capability of Commercially Producing mAb and ADC

Agreeing with the industrial upgrade of the Company and to meet market demand, the Group kicked off effort to expand production capacity in 2021, continuing to bolster the commercial production capacity of its antibody drugs and ADC products to prepare for the continuous expansion of the CDMO/CMO business. According to our strategic plan, we will keep on expanding our production capacity of mAb drugs to more than 16,000L.

Future Development

Dr. Liu Jun, Chief Executive Officer, Chief Science Officer and Executive Director of TOT BIOPHARM, said, "We expect TAB008, our first biological drug, to be approved for launch to market in 2021, hence we will corporate with sizable pharmaceutical plants to roll out our marketing plan. At the same time, we will push forward clinical procedures of ADC TAA013 to enrich the ADC product pipeline. With biological drug CDMO business in China at large booming, leverage on our advantage of "one-base" CDMO/CMO value chain, we will allocate our resources to optimize CDMO business in ADC field, strengthen our brand image as well as consolidate our market position.

"Looking ahead, we believe the competitive advantages of TOT BIOPHARM will become more and more obvious. We will keep presenting employees with ample room for development, and to our partners, with the best strategic solutions, and for shareholders, create value."

FINANCIAL HIGHLIGHTS (as at 30 June 2021)

Hong Kong Financial Reporting Standards Measures:

• Revenue was RMB23.132 million, representing a year-on-year growth of 78% thanks to the Group's proactive expansion of CDMO/CMO business heeding market changes, with relevant revenue up year-on-year growth by a substantial 330%.
• R&D expenses were RMB88.749 million, representing a year-on-year decrease of 11%, mainly attributable to the completion of Phase III clinical trials for the TAB008 project in the second half of 2020, which resulted in a year-on-year decrease in costs of clinical trials, also, R&D work completed for the TOZ309 project, there was a significant reduction of relevant expenses on R&D consumables.
• Selling expenses were RMB11.202 million, representing a year-on-year decrease of 18%, mainly attributable to the Company's sales strategy adjustments, resulting in reduction of relevant costs and expenses.
• General and administrative expenses were RMB26.823 million, representing a year-on-year increase of 11%, mainly attributable to the increase in operating and management expenses related to related to employee, administration and taxation, etc..
• The above mentioned all in account, net loss of the Group for the first half of 2021 reached RMB115.005 million, representing a year-on-year decrease of 11%.

About TOT BIOPHARM International Company Limited (Stock Code: 1875.HK)

TOT BIOPHARM is dedicated to developing and commercializing innovative anti-tumor 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-tumor immunotherapy, gene therapy and viral therapy and pursues R&D and production of tumor-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 active level lyophilized powder and water needle

Using these platforms, the Company has studied and developed various anti-tumor drug series and genres, and has formed a high quality and comprehensive drug product chain. Currently, the Company has 12 drugs under research and development. 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 clinical development to production and 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.