As A Breakthrough Drug For The Expansive Osteoporosis Market, Bogutai® (Teriparatide Injection) Has Been Officially Approved By The China National Medical Products Administration (NMPA) – Biotech Investments

As A Breakthrough Drug For The Expansive Osteoporosis Market,
Bogutai® (Teriparatide Injection) Has Been Officially Approved By The China
National Medical Products Administration (NMPA)

Hong Kong, 22 January 2024 – Uni-Bio Science Group Limited (“Uni-Bio”, the “Company”, together with its subsidiaries, the “Group”), a leading biopharmaceutical company, is excited to announce that the China National Medical Products Administration (“NMPA”) has officially approved the marketing application for BOGUTAI® (teriparatide injection) on January 16, 2024, with the approval number “国药准字S20240004″. This significant milestone heralds a transformative era in orthopedic disease management and expands the choices available to patients.

BOGUTAI® represents the Group’s strategic response to the burgeoning osteoporosis market, both globally and in China. Approximately 200 million individuals worldwide suffer from osteoporosis, with China accounting for a substantial portion of this figure. The “Primary Osteoporosis Diagnosis and Treatment Guideline (2022)” reveals that nearly 90 million people in China have osteoporosis, with the number expected to rise due to an aging population. The medical expenses for major osteoporosis fractures in China are projected to reach a staggering RMB 132 billion by 2035 and rise to RMB 163 billion by 2050.

Set against the backdrop of a growing osteoporosis market, BOGUTAI® stands on the precipice of transforming osteoporosis treatment for postmenopausal women at high risk of fractures. BOGUTAI® is a trailblazer as the first domestically produced disposable pre-filled pen teriparatide injection. It not only matches FORTEO in effectiveness but also surpasses it with a superior safety profile. Developed in a strategic partnership with Swiss self-care titan Ypsomed, BOGUTAI® boasts a pre-filled structure design featuring ultra-fine needles, ensuring high dosage accuracy. This design significantly alleviates patient discomfort, enhancing compliance. Moreover, its pricing, more amenable than FORTEO’s, extends its reach to a broader patient base. This ground-breaking product heralds a new age in user-friendly drug administration, highlighting Uni-Bio’s unyielding commitment to innovation in the biopharmaceutical sector.

Uni-Bio is gearing up for the launch of BOGUTAI®, an endeavor that has been painstakingly prepared for over a year. The company has more than doubled its sales force and orchestrated comprehensive pre-marketing academic promotions directed at potential target customers. This preparatory effort is a testimony to Uni-Bio’s dedication to guaranteeing BOGUTAI®’s successful market penetration. It also underscores the group’s capacity to fulfill its promises. The avenues of success for BOGUTAI® are paved by the twin pillars of product differentiation and an exhaustive launch preparation, marking a promising future in the osteoporosis market.

“Our experience with the successful sales of GENETIME® in the bone department has provided us with invaluable insights and resources that we can leverage for the commercialization of BOGUTAI®,” mentioned by Mr. Kingsley Leung, Chairman of Uni-Bio. “We are confident that our preparation, combined with our expanded sales teams and academic promotions, will ensure BOGUTAI®’s successful launch and acceptance in the market.”

Uni-Bio’s readiness is further illustrated by its substantial investment in a state-of-the-art pre-filled sterile injection production line, manufactured by the renowned German brand “Bausch+Ströbel”, in Beijing. This cutting-edge production line can produce between 3,000 to 8,000 cartridge units per hour and up to 11,000 pre-filled syringe units per hour. This impressive production capacity ensures that Uni-Bio is well-equipped to meet the long-term supply demands for BOGUTAI®.

Mr. Kingsley Leung also said “We’re incredibly proud of the investments we’ve made in our production facilities. These investments are a testament to our commitment to delivering high-quality and innovative products to patients in need. Our production capabilities, combined with our expanded sales teams and academic promotions, position us to successfully commercialize BOGUTAI® and meet the demanding needs of the market.”

Uni-Bio Science Group Limited extends an invitation to potential investors and partners to join us on this exciting journey. With BOGUTAI®’s market approval, the Group stands at the precipice of exponential growth, promising a future filled with innovative healthcare solutions and robust returns on investment.

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About Uni-Bio Science Group Limited

Uni-Bio Science Group Limited is principally engaged in the research and development, manufacture and distribution of pharmaceutical products. The research and development centre is fully equipped with a complete system for the development of genetically-engineered products with a pilot plant test base which is in line with NMPA requirements. The Group also has two GMP manufacturing bases in Beijing and Shenzhen. The Group also has a highly efficient commercialization platform and marketing network. The Group focuses on the development of novel treatments and innovative drugs addressing the therapeutic areas of endocrine such as diabetes and osteoporosis, ophthalmology and dermatology.

Uni-Bio Science Group Limited was listed on the Main Board of the Hong Kong Stock Exchange on November 12, 2001. Stock code: 0690.

For further information, please contact: ir@uni-bioscience.com

Safe Harbor Statement

This press release contains forward-looking statements that involve risks and uncertainties. These statements are based on current expectations, estimates, forecasts, and projections about the industries in which the Group operates, as well as beliefs and assumptions made by the management of the Group.