Institut Pasteur Korea Research

PIVLAZ™, a new drug for prevention of Cerebral Vasospasm in patients with Aneurysmal Subarachnoid Hemorrhage (aSAH), approved in South Korea PIVLAZ will become commercially available in South Korea in early 2025 Tokyo,Japan, Seoul, South Korea,andCambridge,UK, 7 December2023 – Sosei Group Corporation (“Sosei Heptares” or “the Company”; TSE: 4565) today announces that PIVLAZ™ (clazosentan sodium) 150 mg has received marketing approval from the Ministry of Food and Drug Safety (MFDS) in South Korea for the prevention of cerebral vasospasm, vasospasm-related cerebral infarction, and cerebral ischemic symptoms after aneurysmal subarachnoid hemorrhage (aSAH) securing. The MFDS approval is based on scientific and clinical data from an extensive Japanese Phase 3 program submitted by Idorsia Pharmaceuticals Korea (“IPK”), a Sosei Group company. The trials, which involved patients who had undergone clipping surgery or coiling treatment for aSAH, showed that PIVLAZ™ significantly reduced the incidence of cerebral vasospasm-related complications and all-cause mortality within six weeks of aneurysmal subarachnoid hemorrhage. The trials also confirmed the safety pro PIVLAZ™. In South Korea, the Marketing Authorization of PIVLAZ™ is held by IPK and will become commercially available to patients in early 2025. PIVLAZ™ received marketing approval in Japan in January 2022 and was launched in April 2022 by Idorsia Pharmaceuticals Japan ("IPJ”), also a Sosei Group company. PIVLAZ™ has been used in approximately 8,900 patients in Japan as of November 2023. Aneurysmal subarachnoid hemorrhage is a condition involving sudden life-threatening bleeding occurring in the subarachnoid space. It is caused by the rupture of an aneurysm – a weak, bulging spot on the wall of a cerebral artery. Emergency procedure (endovascular coiling or microsurgical clipping) is required to stop the hemorrhage. The bleeding and the release of endothelin, a potent vasoconstrictor produced by the neighboring vascular endothelium, can lead to cerebral vasospasm (constriction of arteries in the brain), usually occurring between four and 14 days after aneurysm securing. This diminishes blood flow to the brain, and about one third of patients consequently experience worsening of their neurological condition. Cerebral vasospasm is one of the leading secondary causes of disability and death in patients with aSAH. Professor Park Ik-seong, Chairman of the Korean Society of Cerebrovascular Surgeons (Professor of neurosurgery at Bucheon St. Mary's Hospital), said: "Cerebral vasospasm after subarachnoid hemorrhage is a serious symptom that can lead to death. However, the lack of effective medication has made it difficult to treat. Now that PIVLAZ™, a drug that can prevent symptoms before they occur, has been approved in South Korea, I hope that it will become available and widely accessible as soon as possible for the sake of patients." Satoshi Tanaka, Dr Med Sci., Executive Officer and Executive Vice President of Sosei Heptares, Chairman of Idorsia Pharmaceuticals Korea, added: “This approval for PIVLAZ™ in a second major market in the APAC region is a significant achievement and brings this groundbreaking and potential life-changing therapeutic advance one step closer to patients in South Korea. Cerebral vasospasm is one of the leading secondary causes of disability and death in patients with subarachnoid hemorrhage. With an occurrence of 9.0 per 100,000 person-years, aSAH is more frequent in South Korea compared to global occurrence rate of 7.9. Therefore, PIVLAZ could be a meaningful treatment option for the patients. Our commercialization plans are well advanced, having benefited hugely from a successful launch in Japan, and we are confident we will be able to make PIVLAZ™ available to physicians and patients in South Korea in early 2025.” Sosei Heptares gained Japan and Asia-Pacific (ex-China) rights to PIVLAZ™, a potent, selective endothelin receptor antagonist, from Idorsia Pharmaceuticals Ltd in July 2023 in the context of its acquisition of IPJ and IPK. PIVLAZ™ is a trademark of Sosei Group. -ENDS- Notes to Editors About the Japanese Phase 3 program The Phase 3 program consisted of two double-blind, randomized, placebo-controlled studies assessing the efficacy and safety of clazosentan in reducing vasospasm and vasospasm-related morbidity and all-cause mortality events in adult Japanese patients post-aSAH. Patients were randomized 1:1 to receive continuous infusion of either 10 mg/hr of clazosentan or placebo for up to a cumulative maximum of 15 days following the onset of aSAH. The two studies followed the same study design, with one enrolling 221 patients whose aneurysm was secured by surgical clipping and the other enrolling 221 patients whose aneurysm was secured by endovascular coiling. Both studies showed that clazosentan reduced the occurrence of cerebral vasospasm-related morbidity and all-cause mortality within 6 weeks post-aSAH with statistical significance (p<0.01 for both studies). The composite endpoint was defined by at least one of the following: All death / New cerebral infarction due to cerebral vasospasm / Delayed ischemic neurologic deficit due to cerebral vasospasm adjudicated blindly by an independent committee. The effect of clazosentan on all- cause morbidity and mortality was also significant (p<0.05) in a pre-planned analysis of the pooled studies whereas a numerical trend was observed in each study on this endpoint. In these Phase 3 studies in Japanese patients post-aSAH, there were no unexpected safety findings. Treatment-emergent adverse events occurring in >5% of the clazosentan group (with a difference of >2% compared to placebo) were vomiting and signs of hemodilution or fluid retention (i.e., hyponatremia, hypoalbuminemia, anemia, pleural effusion, brain and pulmonary edema). Key Literature Endo H, et al. J Neurosurg. Published online April 01, 2022; DOI: 10.3171/2022.2.JNS212914 Daou BJ, et al. CNS Neurosci Ther. 2019; 25(10):1096-1112. de Oliveira JG, et al. Neurosurg Rev. 2007; 30(1): 22-31. Dankbaar JW, et al. Neuroradiology. 2009;51(12):813–819. Frontera JA, et al. Stroke. 2009;40(6):1963–1968. Rabinstein AA, et al.. Stroke. 2005;36(5):992– 997. Dorsch NW, King MT. J Clin Neurosci. 1994; 1(1): 19-26. Etminan N, et al. JAMA Neurol. 2019; 76(5): 588-597. Fujimura M, et al. Cerebrovasc Dis. 2017;44(1–2):59–67. Vajkoczy P, et al. J Neurosurg. 2005;103(1):9–17. Roux S, et al. J Pharmacol Exp Ther. 1997;283(3):1110–1118. Macdonald R L, et al. The Lancet Neurology, 2011; 10(7):618-625. Macdonald R L, et al. Stroke 2008; 39:3015-3021. Kim, JY.et al. Journal of Stroke 2019 Jan;21(1):42-59. About Idorsia Pharmaceuticals Korea Co., Ltd Idorsia Pharmaceuticals Korea (“IPK”) was established, under the leadership of Dr. Satoshi Tanaka, in 2022 to conduct clinical development and prepare the commercialization of innovative and promising compounds for patients in South Korea. IPK is a wholly owned subsidiary of Sosei Group Corporation. About Sosei Heptares Sosei Heptares is a fully integrated biopharmaceutical company focused on bringing life-changing medicines based on world-class science to patients globally. Our vision is to become one of Japan’s global biopharmaceutical champions. Our global business combines our world-leading GPCR-targeted StaR® technology, structure-based drug design and early development capabilities in the UK with a highly experienced clinical development capability and a commercial operation in Japan. We are leveraging these capabilities to generate and advance a broad and deep pipeline of novel medicines across multiple therapeutic areas, including neurology, immunology, gastroenterology and inflammatory diseases. We intend to develop these opportunities for patients in Japan and globally both internally and through our partnerships with global biopharmaceutical companies and emerging technology companies. Sosei Heptares operates from key locations in Tokyo and Osaka (Japan), London and Cambridge (UK) ,Basel (Switzerland) and Seoul (South Korea). “Sosei Heptares” is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565). Sosei, Heptares, the logo and StaR® are trademarks of Sosei Group companies. For more information, please visit LinkedIn: @soseiheptaresco | X: @soseiheptaresco | YouTube: @soseiheptaresco Enquiries: Sosei Heptares – Media and Investor Relations Kentaro Tahara, VP Investor Relations and Corporate Strategy Shinichiro Nishishita, VP Investor Relations, Head of Regulatory Disclosures Maya Bennison, Communications Manager +81 (0)3 5210 3399 | +44 (0)1223 949390 | IR@SoseiHeptares.com MEDiSTRAVA Consulting (for International Media) Mark Swallow, Frazer Hall, Erica Hollingsworth +44 (0)203 928 6900 | SoseiHeptares@medistrava.com Forward-looking statements This press release contains forward-looking statements, including statements about the discovery, development, and commercialization of products. Various risks may cause Sosei Group Corporation’s actual results to differ materially from those expressed or implied by the forward-looking statements, including: adverse results in clinical development programs; failure to obtain patent protection for inventions; commercial limitations imposed by patents owned or controlled by third parties; dependence upon strategic alliance partners to develop and commercialize products and services; difficulties or delays in obtaining regulatory approvals to market products and services resulting from development efforts; the requirement for substantial funding to conduct research and development and to expand commercialization activities; and product initiatives by competitors. As a result of these factors, prospective investors are cautioned not to rely on any forward-looking statements. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

- Hyundai Bioscience announcing the receipt of the phase 2 clinical study report of XaftyTM and its plans for the emergency use authorization - Planning fast track process in oversea countries to enter the global market SEOUL, South Korea, May 2, 2023 /PRNewswire/ -- Hyundai Bioscience (KOSDAQ 048410) announced on the 28th that it had received the clinical study report for the COVID-19 phase 2 clinical trial of its antiviral drug 'Xafty' (code name: CP-COV03). In the announcement, Hyundai Bioscience shared its plans to proceeding emergency use approval (hereafter, EUA) and approval process with the Korean Ministry of Food and Drug Safety (MFDS). Hyundai Bioscience plans to pursue other feasible fast-track processes for Xafty in oversea countries as well. In this clinical trial, Xafty shortened the time required to improve 12 COVID-19 symptoms, including fever and cough, by 4 days compared to the placebo group. When taken within 3 days of symptom onset, the high-risk group improved the recovery time of 12 symptoms 6 days earlier than the placebo group. In addition, the viral load (virus level) was reduced by 56% by 16 hours after the first dosing, which is 14 times that of the placebo group (4% reduction). Hyundai Bioscience research director, DR. G.W. Jin commented "COVID-19 is an RNA virus. It is characterized by a very fast infection rate and constant creation of variants within the same virus family. Hyundai Bioscience's Xafty has excellent efficacy against not only COVID-19 but also all corona-type viruses such as SARS and MERS. With drug repurposing, Xafty has safety and price competitiveness, making it a game changer for COVID-19." These clinical results may be possible with Xafty's active ingredient, niclosamide's mechanism to remove viruses by activating cell autophagy, unlike existing antiviral drugs that inhibit viral replication. As a result of in vitro study on 48 types of drugs selected from 3,000 FDA- and IND-approved drugs by the Pasteur Korea Institute in 2021, niclosamide, an approved anthelmintic drug, was selected as the top candidate for COVID-19 antivirals. Hyundai Bioscience developed Xafty by repurposing niclosamide as a COVID-19 antiviral. In this COVID-19 clinical trial of 300 patients, Xafty proved its safety with no serious adverse events. Considering its no known concomitant contraindications and its price competitiveness compared to existing COVID-19 treatments, Xafty is expected to be a standard COVID-19 treatment in the global market. This clinical trial was carried out in consideration of the Korean EUA system in terms of scale. If Xafty is approved for emergent use, Korea would attain 'pharmaceutical sovereignty' as a country with a leading antiviral drug. Hyundai Bioscience initially planned to enroll 180 patients in this clinical trial but expanded it to 300 to target the EUA introduced in Korea in March 2021. SOURCE Hyundai Bioscience

Research achievements enabled by a combination of advanced AI platforms, research capabilities, and drug discovery technologies SEOUL, South Korea, April 4, 2023 /PRNewswire/ -- Standigm, a company using artificial intelligence (AI) technology for drug discovery and development, and Korean non profit research institute Institut Pasteur Korea announced that they have jointly developed new lead compounds effective in treating resistant tuberculosis (TB). The two organizations conducted a technology acceleration grant project supported by the Right Foundation from 2021 to 2022. They achieved encouraging results by combining their core competencies of artificial intelligence (AI) platforms, infectious disease research capabilities and drug discovery technologies. This breakthrough demonstrates that AI technology can effectively address unmet medical needs for low and middle-income countries that tend to have higher than normal rates of resistant TB. Standigm, the project's lead organization, utilized its drug design artificial intelligence platform, Standigm BEST™, with a scaffold-based molecular generation model and a deep learning prediction model that learned the features of three-dimensional molecular structures. The collaborating institute, Institut Pasteur Korea, utilized its drug discovery platform in a biosafety level 3 laboratory to evaluate the efficacy of new compounds against drug-sensitive and multi-drug-resistant TB (MDR-TB)/extensively drug-resistant TB (XDR-TB) and incorporated the compound information and efficacy evaluation results into Standigm BEST™. In particular, the researchers designed and synthesized various new compounds based on the compounds' structure-activity relationship (SAR) analysis and continuously provided high-quality anti-TB efficacy evaluation results, which Standigm utilized to enhance its AI platform. The two organizations have successfully identified lead compounds for resistant TB through this AI-based drug discovery research collaboration. Standigm and Institut Pasteur Korea have been collaborating on TB drug discovery since 2020. On September 29, 2021, they signed a memorandum of understanding to develop AI-based infectious disease drugs to accelerate their joint research. "There is no vaccination that can guarantee complete protection against TB," said Dr. Sangok Song, co-founder and chief research officer of Standigm. "The BCG vaccination is the only vaccination against TB, and even if antibodies are developed, the lifetime protection rate is only 19% to 27%. We believe that artificial intelligence technology will play an important role in discovering new, low-cost, and effective treatments for TB and other diseases in low- and middle-income countries." TB often spreads in enclosed, poorly ventilated, multi-use facilities where many people stay for long periods, but it is one of the most urgently needed vaccines and treatments in medically underserved countries because of its high prevalence in socio-economically disadvantaged populations and the resistance issues from prolonged use of currently available TB drugs. "Through this collaboration with Standigm, we have presented a complementary and advanced drug discovery research model that combines the accumulated know-how of our researchers with cutting-edge technologies and next-generation artificial intelligence, said Dr. Byung-Kwon Lim, director of the Institut Pasteur Korea." We will accelerate the subsequent development of new drug candidates derived from this research collaboration and contribute to the global effort to end TB." About Institut Pasteur Korea Institut Pasteur Korea is a non-profit research organization that focuses on infectious disease research and development with the goal of improving global public health, and was founded in 2004 based on Korea-France science and technology cooperation. Utilizing its core research capabilities, including innovative screening platforms, the institute is leading the way in understanding the mechanisms of development and accelerating the development of new drugs for emerging infectious diseases such as MERS, Zika, and COVID-19, as well as diseases that threaten humanity today, such as viral hepatitis, tuberculosis, antibiotic-resistant bacterial infections, neglected diseases, and cancers. As a member of the Pasteur Network of 33 laboratories in 25 countries across five continents, the institute plays a key role in leading early drug discovery research within the network. By providing original technologies and promoting multidisciplinary global projects that link Korean and international biomedical sciences, the institute contributes to Korea's scientific, knowledge, and technological resources and helps prepare for and respond to global infectious diseases. () About Standigm Standigm was founded in 2015 to revolutionize drug discovery with artificial intelligence (AI) technology. It's AI technologies cover the entire drug discovery lifecycle (target discovery, hit identification, hit-to-lead, and lead optimization) to continuously develop first-in-class and best-in-class drug discovery projects. Standigm's leading AI platforms include Standigm ASK™, which identifies novel and promising disease targets, and Standigm BEST™, which generates novel chemical structures. By combining the Standigm ASK™ and Standigm BEST™ platforms, Standigm has completed Standigm Magic, a workflow AI that can be completed in an average of seven months from target discovery to lead compound series. Standigm works on various first-in-class and best-in-class drug candidate development projects in collaboration with leading domestic and international pharmaceutical companies and research institutes. For more information about the company, please visit . Press Inquiries Kim Ji-Eun, Head of External Relations, Institut Pasteur Korea [email protected] +82-31-8018-8041 Kyungmoon Kim, Head of Operations at Standigm [email protected] +82-2-501-8118 Gabriella Perez-Silva, PR for Standigm [email protected] 714-875-6424 SOURCE Standigm