<div style="white-space: pre-wrap; margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 12pt;">The molecular structure of OBI-858 is a special toxin protein with a molecular weight of 760 kDa, which is produced by the botulinum toxin type A bacteria during its fermentation. Results of Phase 1 clinical trial showed the product was safe and well-tolerated.</span></div>
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<p><img src="/uploads/%E8%9E%A2%E5%B9%95%E6%93%B7%E5%8F%96%E7%95%AB%E9%9D%A2%202022-08-28%20095223.png" alt="螢幕擷取畫面 2022-08-28 095223.png" width="1474" height="731" /></p>

<div><span style="font-size: 12pt; line-height: 107%; font-family: arial, helvetica, sans-serif;">Obigen&rsquo;s research and development team of OBI-858 botulinum toxin has a strong academic background in biotechnology and biochemistry. They traveled all over the coast of western Taiwan and collected about 500 soil samples over a period of eight years.Through repeating biochemical analysis and whole genome sequence alignments, OBI-858 was discovered. The molecular structure of OBI-858 is a special toxin protein with a molecular weight of 760kDa, which is produced by the botulinum toxin type A bacteria during its fermentation. Originated from the same bacterial species as those on the market.Such bacteria are regulated as biological warfare internationally. Production has reached commercial-scale yields and product quality meets pharmaceutical standards. The production process, through the exclusive purification technology, combines recombinant human serum lbumin (rHSA) and excipient of high moisturizing and anti-aging effect trehalose. It can be said that it is a unique product that has never been seen before on the market.</span></div>
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<figcaption>Trehalose</figcaption>
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<div><span style="white-space: pre-wrap; font-family: arial, helvetica, sans-serif;">The production of botulinum toxin is difficult and challenging; and the drug listing must pass a strict review threshold. The Obigen team has designed technology which is able to select viable strains through a process of fermentation and purification. We've also expanded our own proprietary intellectual property rights through developing a series of technologies to enable: strain improvement, developing cultures, purification and toxin analysis of proteins, identification of viable strains, mass production fermentation, purification process development, method analysis for drug release inspection, stabilizer development, potency studies and indication development. </span></div>
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<div><span style="white-space: pre-wrap; font-family: arial, helvetica, sans-serif;">Botulinum toxin is a controlled, highly toxic protein drug that requires high-standard protective equipment and a rigorous management system to be approved for manufacture. In the beginning of the R&amp;D stage, the Obigen team closely cooperated with the Taiwan Centers for Disease Control (CDC) to establish a series of structures. Obigen has built an API plant in the Zhubei Biomedical Science Park that meets the standards of the International Organization (PIC/s GMP) for the Inspection of Pharmaceutical Products and the production of APIs with clinical and commercialization purposes. In addition to APIs, another key goal of the Dingjin team is the production of sterile finished drugs. </span></div>
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<div><span style="white-space: pre-wrap; font-family: arial, helvetica, sans-serif;">Simultaneously, the high-security third-phase sterile preparation factory will be built in the Tainan Science Park, connecting the Zhubei Biomedical API Factory and the Tainan Aseptic Preparation Factory. The toxin products will first be available in Taiwan and will expand to Asian and global markets.</span></div>
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<figcaption><span style="color: #7e8c8d; font-family: arial, helvetica, sans-serif; text-align: start; white-space: pre-wrap; background-color: #ffffff;">Zhubei Biomedical API Factory</span></figcaption>
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Taiwan Toxin OBI-858 Development Progress

The latest development status