HONG KONG, Jan. 27, 2021 /PRNewswire/ — Sihuan Pharmaceutical Holdings Group Ltd. (the “Company” or “Sihuan Pharmaceutical”, together with its subsidiaries, collectively referred to as the “Group”; Hong Kong Stock Exchange Stock Code: 0460) is pleased to announce its innovation Xuanzhu Biopharmaceutical Co., Ltd. (hereinafter referred to as “Xuanzhu Biopharm”), a pharmaceutical platform company, will acquire 100% of the shares of Beijing Combio Pharmaceutical (hereinafter referred to as “Combio Pharmaceutical”).

The acquisition of Combio Pharmaceutical by Xuanzhu Biopharm has fully expanded the depth and breadth of the company’s innovative drug product pipeline, and introduced the highly potential “Mab Edit” (antibody editing) and “Mebs-Ig” (antibody editing bispecific antibodies), two major antibody technology platforms. With the blessing of the new international pioneering bispecific antibody technology platform, Xuanzhu Biopharm has further enhanced its innovation driving force.

Xuanzhu Biopharm: An international platform for integrated research, production and marketing of innovative drugs

Xuanzhu Biopharm is an innovative drug platform company under Sihuan Pharmaceutical Holdings Group Ltd. In August 2020, Xuanzhu Biopharm introduced SDIC China Merchants Capital and other investment institutions to complete the first round of equity financing, introducing funds of 960 million yuan, and the post-investment valuation has reached RMB 4.5 billion.

Xuanzhu Biopharm has a total of 14 innovative product projects under research, and the pipeline covers multiple fields such as oncology, metabolic disorders and infectious diseases, many of which have entered the late clinical stage. The leading product Birociclib has successfully carried out clinical trials on 3 indications and is a CDK4/6 inhibitor for advanced breast cancer. Among them, the single-drug treatment of Birociclib is already in phase II clinical trials, and if relevant requirements are met, phase III clinical trials can be skipped directly for marketing.

The blockbuster products Anaprazole Sodium and Plazomicin have entered clinical phase III and are about to enter NDA. Anaprazole sodium is a new generation of drugs for digestive diseases and is the only PPI independently developed in China. Its safety and symptom relief are better than similar products. Plazomicin is a new generation of semi-synthetic aminoglycoside antibiotics (a new generation of super antibiotics) developed by Achaogen. It is a clinically urgently needed drug for the end-line. Its clinical application has confirmed that the risk of nephrotoxicity of Plazomicin is significantly lower than that of previous generations of aminoglycoside drugs.

In addition, Benapenem for the treatment of complicated urinary tract infections has entered clinical phase II. Benapenem is independently developed by Xuanzhu Biopharm and has completely independent intellectual property rights. It is the only class 1.1 carbapenem antibiotic in China. Benapenem and Plazomicin can form an innovative anti-infective drug combination. Xuanzhu Biopharm has many products in the fields of tumor, male reproduction, and metabolic diseases that have entered different clinical stages. In the next five years, the company expects to have five products approved for listing.

Different from other emerging Biotech pharmaceutical companies, Xuanzhu Biopharm has a more comprehensive development path. While having a rich and high-quality self-developed product pipeline, it also integrates R&D, clinical development, production and sales. It is an international innovative drug leader enterprise.

State-of-the-art multifunctional antibodies platform + Best-In-Class products, helping Xuanzhu Biopharm value amplification

The Combio Pharmaceutical acquired by Xuanzhu Biopharm is an innovation-driven biological company dedicated to the research and development of multifunctional antibody drugs such as innovative bispecific antibodies and bispecific antibody drug conjugates (ADC). The company has two antibody technology platforms, “Mab Edit” (antibody editing) and “Mebs-Ig” (antibody editing bispecific antibodies), focusing on the research and development of innovative antibody drugs such as major malignant tumors, autoimmune diseases, and infectious diseases. It is a national high-tech enterprise and a high-tech enterprise in Zhongguancun.

Combio Pharmaceutical product pipeline already has 12 products under development, of which KM257/252 is a bispecific antibody drug for cholangiocarcinoma, breast cancer, gastroesophageal cancer, etc. The target is HER2D4/D2, and compared with the main competitor Zymeworks developing bispecific Antibody candidate ZW25 in clinical phase II, KM257 has a better molecular design than ZW25, and may have better drug activity, in vivo stability and safety potential clinically, and belong to the best-in-class multifunctional antibody molecules.

KM254-ADC is a broad-spectrum anti-solid tumor antibody drug candidate for breast cancer, gastric cancer, colorectal cancer and lung cancer with medium and low expression of HER2. The target is HER2D4/D2, and KM254-ADC, as the first bispecific ADC in China, would be in direct competition with Zymeworks’s ZW49 and AstraZeneca’s DS8201, two innovative biological drugs.

As far as the two benchmark drugs are concerned, BeiGene obtained the exclusive development and commercialization of ZW25 and ZW49 in Asia (except Japan), Australia and New Zealand with a down payment of up to 40 million US dollars and a milestone payment of up to 390 million US dollars. And ZW25 and ZW49 are currently in clinical phase II and clinical phase I respectively. Therefore, the commercial prospects of Combio Pharmaceutical KM257/252 and KM254-ADC will also be very impressive.

In addition, the company has anti-Ebola (Ebola infectious disease) ZMAPP triple innovative antibody drugs KM219, anti-coronavirus Middle East respiratory syndrome MERS antibody KM211, antibody fusion protein long-acting hypoglycemic drugs KM320, KM119 (bladder cancer and ovarian cancer) , Immune checkpoint double anti-KM216 (lung cancer) immune checkpoint double anti-KM218 (solid tumor). Xuanzhu Biopharm’s integrated high-quality platform for biological research, production and marketing is expected to greatly shorten the time for product incubation and maturity, and will provide continuous resources for the company’s innovative research and development in the future.

Summary

Bispecific antibodies, as a hot and cutting-edge technology in the field of biomedical research and development, are an important battlefield for innovative pharmaceutical companies in the future. As a rare domestic innovative drug company with a complete independent research and development industrial chain, Xuanzhu Biopharm has strategic significance to deploy in this field. This acquisition enables Xuanzhu Biopharm to obtain a powerful in-house research and development technology platform, which can carry out research and development of bispecific antibodies and ADC drugs at the same time, which strengthens the company’s comprehensive ability in biologics research and development.

Mr. Zhu Xiaodong, the founder of Combio Pharmaceutical, said: “Sihuan Pharmaceutical takes innovation as the leader, adheres to the core concept of innovation-driven, imitation and innovation, and continuously enriches its high-quality innovative drug product pipeline. It is an international innovative technology company worth learning. At the same time, Sihuan Pharmaceutical has a strong production capacity and a mature sales system, which is a very important boost for the commercialization of innovative drugs. Xuanzhu Biopharm’s vision in the field of innovative drugs is highly important for building a technical platform for next generation antibody therapeutics, and this is also the values that Combio Pharmaceutical has long followed. In the future, Combio Pharmaceutical and Xuanzhu Biopharm will not only enable the integration of the R&D team to strengthen the future, but also believe that Combio Pharmaceutical’s research results will definitely be incorporated into Xuanzhu Biopharm’s mature research, production and marketing system. It creates greater value and brings the gospel to patients faster.”

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical Holdings Group said: “Combio Pharmaceutical’s Her2 targeting bispecific antibody and bispecific ADC can be jointly developed with the Group’s existing small molecule breast cancer drugs. Leveraging the attributes of small molecules and biologics can bring a strong biomedicine R&D pipeline to the innovative R&D of the group’s subsidiaries, and at the same time bring a good R&D capability and product pipeline to the small molecule innovative drug R&D platform currently owned by the group. It is believed that the acquisition will be a milestone event in the Group’s macromolecular sector, and it may play an important role in amplifying the value of Xuanzhu Biopharm’s future financing and development.”

About Sihuan Pharmaceutical Holdings Group Ltd.

Sihuan Pharmaceutical Holdings Group Ltd.  (Stock code of the Hong Kong Stock Exchange: 0460, “Sihuan Pharmaceutical” or “Group”) was founded in 2001 and was listed on the Hong Kong Main Board in 2010, is a pharmaceutical group with integrated R&D, pharmaceutical manufacturing and marketing and sales capabilities. It is also one of the China’s largest suppliers of cardio-cerebral vascular (“CCV”) prescription drugs. Sihuan Group focuses on major high growth therapeutic areas including oncology, diabetes, aesthetic medicine and CCV as well as other high growth areas. The Company has successfully established the following industry-leading core business platforms.

Subsidiary Xuanzhu Biopharmceutical Co., Ltd., focuses on major therapeutic areas including oncology, metabolic disease and non-alcoholic steatohepatitis (NASH). Xuanzhu has 14 innovative R&D products projects, many of them are in late stage clinical trials and have independent intellectual property rights; A number of products from the generic drug R&D platform have successively received production approvals and passed the consistency evaluations. The “Non-PVC solid-liquid double-chamber bag ready-to-match infusion” product developed by their affiliated company Beijing Ruiye, has been granted multiple specifications and approvals by the National Medical Products Administration (NMPA). It is the first and only domestic company to obtain registration approval for a ready-to-match infusion product by the NMPA in China. The product will further strengthen Sihuan Group’s leading position in antibiotic double-chamber bag market; Sihuan Pharm owns a leading generic drug R&D, manufacturing, marketing and sales platform which has a strong ability to “monetize” new products. Sihuan has more than 1000 marketing and sales professionals covering thousands of hospitals. Their strong professional sales network provides 100% coverage of China’s provinces enabling them to accelerate the penetration of new products throughout the country; Sihuan Medical Aesthetic Platform is the exclusive distributor of “Type A Botulinum Toxin for Injection” (Letybo 100U) produced by Hugel, a Korean biopharmaceutical company. Hyaluronic acid and PLLA are currently being researched and are expect to be launched soon. Sihuan Medical Aesthetic is expected to become a super accelerator for the growth of Sihuan Pharmaceutical’s business and corporate value enhancement; Jilin Kangtong API Platform completes Sihuan Pharmaceutical Group’s chain of chemical generic drugs and the strategy to integrate the process of ” API + CDMO + preparations”. The Company’s core competitiveness is to develop essential features for client’s products specifically targeting drugs such as anti-virus, anti-coagulation, anti-fungal among others; Jilin Aokang manufactures high-quality Chinese patent medicines and oral solutions, it has the only high-content CBD scientific research planting qualification for industrial hemp in Jilin Province. The Company is well positioned in R&D and industrialization of high-content CBD medicinal and medical materials.Through the layout of the entire industry chain, Sihuan Group can effectively guarantees the safe and stable supply of API products and has unique anti-risk capabilities and stability in its business growth.

For more information on Sihuan Pharmaceutical, please visit the company website https://www.sihuanpharm.com/ .