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Jiangsu Sinopep Allsino Biopharmaceutical Co., Ltd.: FDA cGMP peptide API supplier

Release time：2024-10-01 10:31:01 Source：DuHao

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Jiangsu Sinopep Allsino Biopharmaceutical Co., Ltd. is a prominent biopharmaceutical enterprise specializing in the research, development, and manufacturing of peptide drugs and small molecule drugs. Founded in April 2009, the company has established itself as a national high-tech enterprise and a provincial technology-based enterprise, reflecting its commitment to innovation and excellence. Headquartered in the national Lianyungang Economic and Technological Development Zone, Sinopep operates with over 1,000 employees and continues to drive advancements in the pharmaceutical industry.

On May 20, 2021, Jiangsu Sinopep Allsino Biopharmaceutical Co., Ltd. was successfully listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange under the stock name "Notai Bio" (stock code: 688076). This milestone has enabled the company to enhance its visibility and access to capital, further bolstering its research and development (R&D) capabilities and production capacity.

The company's mission is to overcome technical bottlenecks in drug R&D and production through continuous technological innovation. It aims to establish a comprehensive industrial chain that encompasses advanced pharmaceutical intermediates, raw materials, and finished preparations. By providing global partners with green, low-cost, high-quality, and efficient pharmaceutical-related products and technical services, Jiangsu Sinopep is positioning itself as a key player in the global biopharmaceutical landscape.

Research and Development

Sinopep's R&D strategy emphasizes technological innovation as the primary driving force. The company has consistently invested more than 10% of its total operating income into R&D over the past three years, showcasing its dedication to enhancing independent innovation capabilities. With three provincial R&D centers—Notai Bio, Ausino, and Xinbosi—the company has assembled a highly qualified R&D team, including over 160 professionals, with more than 40 holding advanced degrees (master's and doctorate) and six being returnees from overseas.

The R&D centers are equipped with cutting-edge software and hardware, facilitating technology integration that supports the company's comprehensive business framework. Notably, Sinopep collaborates with Professor Hartmut Michel, a German biochemist and Nobel Prize winner in Chemistry, to accelerate its technological advancements through a Nobel Prize workstation. The company boasts 77 authorized patents, including 36 invention patents, and has established robust collaborations with numerous universities and research institutions.

Production Capabilities

Jiangsu Sinopep has developed two state-of-the-art production bases located in Lianyungang, Jiangsu, and Jiande, Zhejiang. These facilities adhere to international regulatory standards, enabling the company to cover the full industry chain, from pharmaceutical advanced intermediates to active pharmaceutical ingredients (APIs) and preparations. The company’s product portfolio includes hard capsules, tablets, lyophilized powder injections, small-volume injections, and various APIs, all of which have received national Good Manufacturing Practice (GMP) certification.

The peptide API quality system has successfully undergone US FDA cGMP inspections on three occasions (2014, 2016, and 2019), achieving "zero defects" during the most recent re-inspection in January 2019. This achievement underscores the company's commitment to maintaining high-quality standards, enhancing its competitive edge in the international market.

Product Portfolio and Recent Developments

Jiangsu Sinopep's diverse product range addresses critical therapeutic areas, including diabetes, cardiovascular diseases, anti-tumor treatments, antiviral therapies, and AIDS. The company has an impressive production capacity, including 800 tons of raw materials annually, 200 million units of solid preparations, and 15 million units of injections.

Recently, on October 14, 2024, Jiangsu Sinopep received the "Drug Registration Certificate" for Compound Sodium Picosulfate Granules from the State Drug Administration. This Class 3 chemical drug is designed for intestinal cleansing prior to radiological examinations, endoscopy, or surgery. The addition of this product fills a significant gap in the company's pipeline for digestive system disease medications, enriching its independently developed preparation product line.

Financial Performance

Preliminary calculations from the financial department indicate that the net profit attributable to the owners of the parent company in the third quarter of 2024 is expected to range from RMB 100 million to RMB 140 million. This represents a substantial increase of RMB 50,139,700 to RMB 90,139,700 compared to the same period last year, reflecting a year-on-year growth rate of 100.56% to 180.78%. After deducting non-recurring gains and losses, the net profit is also projected to show significant growth, further illustrating the company’s robust financial health and strategic positioning in the biopharmaceutical sector.

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