300436CosunterSZSE

Fujian Cosunter Pharmaceutical Co., Ltd.

广生堂

300436

Shenzhen Stock Exchange

BoardChiNext of Shenzhen Stock Exchange
IndustryPharmaceutical Manufacturing
ListedApril 22, 2015
Websitewww.cosunter.com
IR Emailzhangqinghe@cosunter.com
Phone(+86)591-38265188
AddressBuilding No. 16, Phase II, Innovation Park, Haixi High-tech Industrial Park, No. 7, Wulongjiang Middle Avenue, Fuzhou High-tech Zone, Minhou County, Fuzhou, Fujian

Company Profile

1. First-Mover Advantage in Innovative Drug R&D As a leading innovative drug R&D and manufacturing company in China, deeply entrenched in the antiviral and liver health sectors, the company has actively and consistently pursued an innovation-driven development strategy since its listing in 2015. It has strategically expanded into areas such as liver cancer, non-alcoholic steatohepatitis (NASH), and clinical cure for hepatitis B, aiming to fill industry gaps and actively fulfill corporate social responsibilities by initiating the development of innovative anti-COVID-19 drugs. Through years of innovative transformation and development, the company has achieved a breakthrough in innovative drugs, with its anti-COVID-19 drug Taizhongding approved for market launch and commercialization. It now possesses full-cycle R&D capabilities for innovative drug development and has established a pipeline of innovative drug products. Additionally, the company has strengthened global intellectual property protection for its innovative drugs, with PCT international patent filings for its series of innovative drug compounds, and has successively obtained patent authorizations in China and other countries or regions. By continuously increasing R&D investment and refining its intellectual property layout for innovative drugs, the company has seized a certain first-mover advantage in the innovative drug market and is gradually building its unique moat and core competitiveness. 2. Experienced Management Team Advantage The company has continuously improved the construction of its innovative drug R&D and management team, boasting a professional team that covers various stages of the drug development lifecycle and comprehensive corporate operations. Core R&D and management personnel hail from multinational corporations such as Pfizer, GSK, and AstraZeneca, bringing extensive experience in clinical research, regulatory submissions, and commercialization of innovative drugs. In the future, the company will continue to attract outstanding management and R&D talent to enhance its independent innovation capabilities and drive high-quality development. 3. Strategic Focus and Diversified Product Pipeline Advantage Through independent R&D, collaborative development, and industrial mergers and acquisitions, the company has established a drug matrix that focuses on nucleos(t)ide anti-HBV drugs and liver-protecting drugs, with comprehensive coverage of liver health product lines including hepatitis B, hepatitis C, fatty liver disease, liver cancer, and liver protection. This is complemented by products in areas such as anti-COVID-19, cardiovascular health, and men’s health. In the future, with the anticipated approval and market launch of high-end generic drugs such as Clopidogrel Bisulfate and Aspirin Tablets, as well as the successive entry of multiple innovative drug R&D products into the harvest phase, the company’s product pipeline will be further enriched and upgraded, enhancing long-term development momentum. 4. Brand and Channel Advantage With years of dedication to the anti-hepatitis B virus drug sector, the company has established a sales force spanning all provinces in China and a sales network covering capitals, cities, and counties nationwide. It has also built solid cooperative relationships with outstanding distributors in this field. Through years of academic promotion and brand building, the company has earned a reputation among doctors and patients in this sector, establishing a strong brand image that lays the foundation for future revenue growth and the market introduction of new products. Simultaneously, the company adapts to industry changes by continuously exploring diversified sales channels, actively investigating new retail models in healthcare, expanding new retail channels (such as online pharmacies and internet hospitals), and implementing digital marketing practices to empower channel construction. 5. Supply Chain and Quality Control Advantage The company always prioritizes the stability and improvement of product quality as a key objective in its daily operations. It continuously strengthens its quality culture through comprehensive training on products, regulations, quality tools, and management capabilities to enhance overall emphasis on product quality standards. In accordance with the "Drug Administration Law of the People’s Republic of China" and the "Good Manufacturing Practice (GMP)" regulations, the company has established a stringent product production quality assurance system. From the sourcing and production of raw materials to product manufacturing, R&D management, and clinical research, all processes adhere to GMP quality control standards. Through the control of key indicators, the company ensures the continuous and stable operation of its quality management system.

Full description

Holding steadfast to the corporate mission of “spreading kindness and improving people’s well-being”, Cosunter is committed to delivering scientific solutions for liver health, driving the innovation of new drugs, and carrying through the innovation-driven development strategy. By employing a variety of approaches such as independent R&D, collaborative development, and industrial mergers and acquisitions, Cosunter has established a full-fledged portfolio of liver health products, with core sales drivers being nucleos(t)ide analogue anti-HBV drugs and hepatoprotective drugs aimed at treating hepatitis B, hepatitis C, fatty liver, liver fibrosis, and liver cancer, and protecting liver health. Cosunter has also actively expanded into products in the fields of antiviral, cardiovascular and male health products. In the years to come, Cosunter will continue to advance its innovation-driven development strategy by underpinning the development of innovative drugs with generic drugs and promoting the integration of generic and innovative drugs, balancing internal growth with external expansion, and continuously enriching its product pipeline and optimizing its product mix. Our goal is to become a leading innovator in the realm of antiviral and liver health drugs. 1. Generic Drugs 1.1 Marketed Products (1) Antiviral Drugs and Hepatoprotective Drugs Cosunter is a high-tech Chinese pharmaceutical company offering a full-fledged portfolio of nucleos(t)ide analogue anti-HBV drugs, including tenofovir alafenamide furarate, tenofovir disoproxil fumarate, entecavir, lamivudine, and adefovir dipivoxil. Among them, tenofovir alafenamide furarate, tenofovir disoproxil fumarate, and entecavir are recommended as first-line drugs in the prevention and treatment of chronic hepatitis B worldwide. Additionally, Cosunter's subsidiary, Zhongxing Pharm, produces silybin drugs that are natural plant-based hepatoprotective drugs widely used in the field of liver protection. (2) Male Health and Cardiovascular Drugs Cosunter's product offerings also includes male health drugs such as sildenafil citrate tablets (branded as JINGGE) and tadalafil tablets (branded as JIUGE)、dapoxetine tablets(branded as DAGE), as well as cardiovascular drugs such as rivaroxaban tablets (branded as TONGNUOAN) and pitavastatin calcium tablets (branded as QINGNUOAN), which provide beneficial supplements to liver health. 1.2 Key Generic Drugs in Development With a particular focus on hepatoprotective drugs, Cosunter has progressively rolled out highly competitive antiviral, cardiovascular and mental health drugs. The current pipeline of key generic drugs in development includes clopidogrel bisulfate and aspirin tablets, ursodeoxycholic acid capsules, etc. 2. Innovative Drugs Holding fast to an innovation-driven development strategy, Cosunter has initiated the research and development of six innovative drugs for the treatment of COVID-19, solid tumors, non-alcoholic fatty liver disease and liver fibrosis, as well as the clinical cure of hepatitis B. All of these drugs have been approved for clinical trials. Among them, GST-HG171 is in Phase II/III pivotal clinical trials and GST-HG141 is in Phase II clinical trials. Both have the first-mover advantage. (1) Innovative Antiviral Drug - GST-HG171 GST-HG171 is a high-activity, high-selectivity oral 3CL protease inhibitor that exhibits broad-spectrum inhibition of COVID-19 and its derived mutant strains. In the preclinical trials, Phase I clinical trials, and investigator-initiated trials (IITs), GST-HG171 demonstrated broad-spectrum antiviral activity against different COVID-19 variant strains and better pharmacological characteristics compared to Pfizer's Paxlovid. This resulted in a shorter duration for the negative conversion of viral RNA. Moreover, the recommended single dosage for GST-HG171 in clinical trials is only 150mg (twice daily), lower than Paxlovid's 300mg (twice daily). This may further improve medication safety while maintaining antiviral efficacy, and provide cost advantages during future commercialization. (2) Innovative Drug for Clinically Curing Hepatitis B - GST-HG121/131/141 In 2015, Cosunter proposed a clinical cure roadmap for Hepatitis B known as the "Peak Climbing Initiative", which involves the combined use of GST-HG131/GST-HG121, GST-HG141, and existing nucleos(t)ide analogues for multi-target therapy. With years of experience in the field of anti-HBV drug development, Cosunter enjoys a first-mover advantage and has achieved several breakthroughs in developing an innovative drug for curing HBV clinically. GST-HG141 is a core protein modulator that effectively reduces HBV cccDNA, and is the world's first-in-class MOA II HBV core protein modulator. It is a critical component for the clinical cure of HBV with specificity targeting the virus and minimal risk for host-targeting effects. Currently, there are no similar targeted drugs available globally. Phase I clinical trials have shown that GST-HG141 is safe and effective for Chinese chronic HBV patients with good pharmacological and pharmacokinetic properties. GST-HG131 is the world’s first-in-class HBV surface antigen inhibitor. It is the first ever HBV surface antigen (HBsAg) inhibitor approved in China for clinical trials, featuring an innovative treatment mechanism for inhibiting HBsAg secretion, inducing HBV-RNA degradation, and lowering HBSAg levels with proved safety. GST-HG121, also an HBV surface antigen inhibitor, works by degrading RNA and effectively inhibiting HBSAg expression. This helps reduce HBsAg titers and potentially increase HBsAg seroconversion rates, thus helping restore immune surveillance mechanisms. Furthermore, Cosunter is steadily advancing the clinical research for GST-HG161, a novel targeted drug for solid tumors, and GST-HG151, a novel anti-liver fibrosis drug.

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