On January 11, 2022, Kexing Biopharmaceutical Co., Ltd. (stock code: 688136.SH, hereinafter referred to as Kexing Biopharm) and TOT BIOPHARM (hereinafter referred to as Suzhou TOT BIOPHARM), a wholly-owned subsidiary of TOT BIOPHARM International Company Limited (stock code: 1875.HK) held an online signing ceremony for the signing of the License Agreement on Exclusive Overseas Commercialization for Bevacizumab (hereinafter referred to as the License Agreement). Pusintin^?, the Bevacizumab drug, was approved for marketing in mainland China on November 30, 2021, while Kexing Biopharm has obtained exclusive commercial licenses in countries and regions across the globe (hereinafter referred to as cooperative regions), with China, the EU (subject to the 2021 member states), the UK, the US and Japan.

Online Signing Ceremony

Pusintin^? contains monoclonal antibodies (mAbs) for an anti-vascular endothelial growth factor (anti-VEGF) and is a biosimilar for Avastin^?. As a widely used anti-VEGF mAb, Avastin^? has been proven effective since entering the market in 2004. Avastin^? has also been globally approved for various anti-tumor therapies. It can be used to treat metastatic colorectal cancer (mCRC), metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC), glioblastoma (GBM), renal cell carcinoma, ovarian carcinoma, cervical carcinoma, breast cancer and liver cancer. In China, Avastin^? has been approved for use in the therapeutic treatment of nsNSCLC, mCRC, GBM, hepatocellular carcinoma (HCC), ovarian carcinoma, and cervical carcinoma. According to the Technical Guidelines for Biosimilars' Similarity Evaluation and Indication Extrapolation issued by the Center for Drug Evaluation of National Medical Products Administration (NMPA), Pusintin^? meets the requirements of making extrapolation to all indications Avastin^? being approved.

According to statistics from the International Agency for Research on Cancer of the World Health Organization (IARC), lung cancer and colorectal carcinoma are the two types of cancers with the largest number of new cases in China. In 2020, the new cases of the two types were 816,000 and 555,000 respectively. Bevacizumab can be used in a broad range of indications and with the increased need of patients, it has great potential in the Chinese market. According to data from IQVIA, in 2020, Bevacizumab saw global sales worth USD 6.09 billion, while the number for China was RMB 3.63 billion.

Suzhou TOT BIOPHARM will follow the terms and condition of the License Agreement and grant Kexing Biopharm the exclusive commercialization right in the cooperative regions. In this round of cooperation, the introduced vital antibody drugs give impetus to the development and expansion of product lines in Kexing Biopharm, contributing to the optimization of the overseas market layout and offering more treatment options for unmet clinical needs. Meanwhile, the cooperation has built a foundation for future overseas sales of self-developed or introduced products. It has also increased the number of overseas marketing channels, expanded the sales scale and enhanced the international influence of Kexing Biopharm.

Zhao Yanqing, General Manager of Kexing Biopharm, said that the cooperation has led to remarkable achievements. Suzhou TOT BIOPHARM has advantages in commercial production and has a cost-effective mechanism, while Kexing Biopharm has great confidence in promoting the global commercial operation of Pusintin^? to create greater value. As an innovation-oriented biopharmaceutical company, Kexing Biopharm is developing in a rapid but stable manner. In recent years, its overseas business has been growing at a high speed and its products has been approved and sold in over 30 countries. Over years of overseas operation, Kexing Biopharm has accumulated great experience and set up an effective commercialization mechanism. Our overseas teams can effectively conduct project launching, promoting and registration procedures of different countries. Being a listed company, Kexing Biopharm has also accelerated the introduction of domestic high-end biopharmaceuticals to promote sales, enhance its reputation, build a Chinese brand and provide more and better choices for people in need.

Dr. Liu Jun, CEO of TOT BIOPHARM, said, “We are very pleased to enter into the license and cooperation agreement with Kexing Biopharm, which is a domestic benchmarking enterprise to expand overseas markets. We aim to quickly introduce Pusintin^? into the fast-growing emerging market through close collaboration between TOT BIOPHARM and Kexing Biopharm. This is not only a critical step for Pusintin^? to enter the international market, but also a significant momentum to closely follow the national call and comply with “the Belt and Road” strategic initiative, as well as providing high-quality and affordable oncology drugs to cancer patients in emerging countries, contributing to the national medicine’s development and fulfilling our responsibility to the shared future of mankind as a whole.”

About Pusintin^?

Pusintin^? (bevacizumab injection) is a biological antibody drug self-developed by TOT Biopharm, which has obtained the marketing approval from the National Medical Products Administration (NMPA) of China recently and is used for the treatment of advanced, metastatic or recurrent non-squamous non-small-cell lung cancer(nsNSCLC) and metastatic colorectal cancer (mCRC). Pusintin^? is a biosimilar to Avastin^?, which has been approved for the treatment of nsNSCLC, mCRC, glioblastoma multiforme (GBM), hepatocellular carcinoma (HCC), ovarian cancer and cervical cancer in China.

About Kexing BIOPHARM Co., Ltd. (Stock Code: 688136.SH)

Kexing Biopharm is an innovative biopharmaceutical enterprise mainly engaged in the R&D, production and sales of recombinant protein therapeutics and microecological agents. We focus on pharmaceutical research in the therapeutic fields of antiviral, oncology, immunology, hematology, digestion and degenerative diseases.which will benefit patients all over the world and help us turn into a leader in high-quality biologicals.

In recent years, we have achieved continued and rapid growth in its business, becoming a leader in the recombinant protein therapeutics industry. Our core products, remained at the forefront of similar varieties in China, have been adopted by over 18,000 sales terminals, including over 6500 hospitals in the provinces, municipalities and regions across China, and accessed into and sold in over 30 countries, including Brazil, Philippinesand Indonesia.

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 oncology treatments brand worthy of the trust of patients and their family members, and medical professionals.

The Company has set up an internationally competitive innovative drugs commercial production base equipped with including antibody drug substance and formulation production facility, as well as an integrated ADC commercial production facility capable of putting out both ADC drug substance and freeze-dried formulation. By the first half of 2022, the production capacity for biological drugs of the base is expected to reach approximately 20,000 liters, realizing quality commercial production of innovative drugs.

Given its competitiveness in R&D andproduction, TOT BIOPHARM has developed many series and varieties of oncology drugs, forming a high standard and comprehensive pharmaceutical product chain.In addition to innovating in developing its own drugs, it also has strategic partners in domestic and overseas pharmaceutical corporations to provide one-stop CDMO services from R&D, crafts development, clinical trials, registration and application to commercial production. Upholding its “facilitating innovation and mutual growth with a focus on quality” service concept, the Company is committed to hastening development and production of chemical drugs and biological drugs, especially ADC drugs, and to empowering its partners to the ultimate end of benefiting patients.