Apeloa Pharmaceutical Co., Ltd.

HONG KONG, Jan. 26, 2023 /PRNewswire/ -- Fosun International Limited ("Fosun International" or the "Company") (HKEX: 00656) was informed by The Asset, the renowned international asset management and investment magazine, that Fosun has garnered the Platinum Award at The Asset ESG Corporate Awards 2022. This year, Fosun International was accredited with the Platinum Award by The Asset for the first time after being presented with the Gold Award for four consecutive years. The Asset also awarded Fosun International Best Investor Relations Team Award. Organized by The Asset, a renowned Asian financial magazine, The Asset Corporate Awards that has been running for many years is one of the world's leading environmental, social and governance (ESG) awards. This year, Fosun International was accredited with the Platinum Award at The Asset ESG Corporate Awards 2022, reflecting the magazine's recognition of Fosun's outstanding performance in various fields including financial performance, management, corporate governance, social and environmental responsibility, investor relations, information disclosure and corporate communication. Other recipients of the Platinum Award include Agricultural Bank of China, Bank of China (Hong Kong), China Overseas Land and Investment, China Unicom, Kerry Properties, Shui On Land, Sino Land, etc. Fosun International's ESG performance has been highly recognized by rating agencies In recent years, global investors and stakeholders have attached increasing importance to the ESG performance of enterprises. Fosun International has been continuing to promote the development of ESG and has achieved impressive results. Its MSCI ESG rating was AA and the Hang Seng Sustainability rating was A. Fosun International has been selected as a constituent stock of Hang Seng ESG 50 Index (top 50 large-to-mid cap) for two consecutive years and it has been included as a constituent stock of the Hang Seng Corporate Sustainability Benchmark Index for three consecutive years, which includes 87 Hong Kong-listed companies with the most outstanding performance in corporate sustainability (top 20% of the Hang Seng Composite Index constituent stocks). All these affirm Fosun's ESG achievements and the global recognition of Fosun's ESG efforts. Fosun ' s two treasures, " drug + vaccine " highlight the G roup' s innovative achievements and social responsibility contributions to the fight against the pandemic The technology innovation capabilities that Fosun accumulated over the years have continued to bear fruit. On 19 December 2022, COMIRNATY®, including the monovalent COVID-19 mRNA vaccine (BNT162b2) and the bivalent vaccine which can protect against the Omicron variant, was officially registered as a drug/product (biological product) in Hong Kong SAR. The self-paid vaccination service of COMIRNATY® bivalent vaccine was launched in Hong Kong SAR and vaccination is open to people including Mainland Chinese residents starting from 6 January 2023. After the self-paid vaccination service of COMIRNATY® monovalent COVID-19 mRNA vaccine has opened for non-local residents in Macau SAR last year, the COMIRNATY® bivalent vaccine was approved by Macao SAR as a regular imported vaccine on 20 January 2023, and people in need may receive a booster dose with prescription. As regards Azvudine, the oral medication for COVID-19, it is now included in the medical insurance scheme in 31 provinces, autonomous regions, and direct-administered municipalities across the country. In addition to tertiary hospitals and secondary hospitals, Azvudine has gradually covered grassroots medical institutions in many provinces. The accessibility of Azvudine has been greatly enhanced, helping the vast areas build a barrier against severe cases. Improving communication in the global capital market, Fosun's long-term strategy has been recognized by investors In recent years, the global market has been going through different stages of the economic cycle. Fosun has focused on its core businesses, deepened innovation and globalization, and maintained long-term effective communication with the capital market and investors. In 2022, Fosun overcame challenges such as the pandemic, and completed 420 domestic and overseas investor roadshows in 11 countries and regions around the world to actively communicate with global investors. Fosun has received high recognition and support from investors for its long-term strategy and corporate value. The Asset awarded Fosun International the "Best Investor Relations Team Award", which demonstrates the market's recognition of Fosun International's corporate management and operations, information disclosure, transparency, and communication with stakeholders, and affirms Fosun's long-term investment value. Despite the headwinds of anti-globalization in 2022, Fosun is still a firm practitioner of globalization. In 2022, COMIRNATY® COVID-19 mRNA vaccine continued to provide an anti-epidemic barrier for Hong Kong SAR, Macao SAR and the Taiwan region; Club Med opened new resorts; Lanvin Group was successfully listed on the New York Stock Exchange. In the face of uncertainties, Fosun remained committed to technology and innovation in order to weather market cycles. HANQUYOU, independently developed by Henlius, was successfully launched in Australia after entering the European Union market; the registration application in the Chinese Mainland for the new indication of Yi Kai Da, China's first CAR-T cell therapy was officially accepted. Fosun attaches great importance to its development. No matter how policies and markets change, Fosun will always devote its best efforts. Fosun is actively making strategic adjustments in the face of the constant changes in the macro environment and revealed the future development direction of Fosun: Fosun will reinforce its positioning as "a global innovation-driven consumer group", focus on its core businesses strategically around the consumption needs of global families, and strengthen the two core growth engines of globalization and innovation. The market is optimistic about Fosun's strategies of accelerating its strategic transformation and focusing on household consumption sectors. A number of investment banks, including Morgan Stanley, Citi, Goldman Sachs and Nomura, have published reports and assigned Fosun International an "Overweight" or "Buy" rating. Market analyst believes that as the "one-off" negative impact of the external environment clears, Fosun's continuous focus on the family-oriented consumer sector will usher in an important period of opportunity for business rebound in 2023. Since the beginning of the year, Fosun's main businesses centering on household consumption, such as Health, Happiness, and Wealth, have shown signs of strong recovery and Fosun's forward-looking efforts in the anti-epidemic field have gradually borne fruit. The two flagships of Fosun's Happiness segment, Fosun Tourism Group and Yuyuan, and other businesses have shown strong signs of recovery. According to market sources, when the domestic tourism industry suffered a huge setback in 2022, Fosun Tourism Group still stood firm to build global presence and opened seven new Club Med resorts throughout the year. Club Med's global bookings in the first half of 2023 have greatly exceeded the same period in 2019 before the pandemic. During the 2023 New Year holiday period, Atlantis Sanya, FOLIDAY Town Lijiang and other businesses in China all performed better than their respective pre-pandemic levels, and many Club Med resorts in China recorded close to 100% occupancy. During the 2023 New Year holiday period, the 2023 Yuyuan Garden Lantern Festival in the Grand Yuyuan attracted a large number of tourists. It is expected that the Spring Festival will further unleash consumption vitality. Fosun's solid fundamentals and recovery potential have been widely recognized by financial institutions and investors On 16 January 2023, Shanghai Fosun High Technology (Group) Co., Ltd. ("Fosun High Technology"), the domestic operating entity of Fosun International, received a RMB12 billion syndicated loan from eight domestic banks. This is the largest private enterprise loan led by five major state-owned banks in cooperation with policy banks and joint-stock banks since the Central Economic Work Conference explicitly proposed in December 2022 to encourage and support the development of the private economy and private enterprises. Moreover, Fosun High Technology successfully completed bookbuilding for the RMB1 billion super & short-term commercial paper on 13 January 2023. According to a report published by S&P Global Ratings, Fosun International's total debt at the holding company level could drop by 15%-25% in 2023 as the company continues to dispose assets and pay down matured bonds, thereby further improving its liquidity. According to incomplete statistics, Fosun's return of capital from its asset reduction in 2022 has reached tens of billions of yuan. Morgan Stanley also issued a report commenting that Fosun's syndicated loan can further improve its liquidity, significantly helping lift market confidence in Fosun's stability. Looking ahead, the reopening of China will help boost fundamentals, especially in businesses such as tourism, retail, and investment. 2022 marked the 30th anniversary of Fosun's establishment. Standing at the new starting point of 30 years of establishment, Fosun will continue to strengthen its core businesses, deepen innovation and globalization. Fosun will continue to join hands with customers, partners, investors and all parties in the society to forge ahead and continue to uphold its original aspiration of "Contribution to Society", so as to actively promote the sustainable development of ESG to fulfil Fosun's mission of "Creating Happier Lives for Families Worldwide". About The Asset Corporate Awards Organized by The Asset, a renowned Asian financial magazine, The Asset Corporate Awards is one of the world's leading and longest-running awards. The judging committee, which composes of professional investors and analysts, assesses the overall performance including financial performance, corporate governance, social and environmental responsibility, information disclosure and corporate communication of listed companies in the Asia-Pacific region through online questionnaire submissions made by the participating companies, then follow by obtaining feedback from the investor community and analysts through interview, in order to select and award the winning companies based on the overall score. It has a strong influence in Asia and the international capital markets. SOURCE Fosun

Promising efficacy and safety profiles were observed in prior Phase II studies in acute ischemic stroke patients treated with recanalization therapies. The ENIS-3 trial has achieved >33% of target enrollment (948 patients). The independent data monitoring committee (IDMC) has completed interim analysis and indicated that the trial should continue. The RODIN trial has achieved >45% of target enrollment (496 patients) in 7 months. YONGIN, South Korea, Sept. 19, 2022 (GLOBE NEWSWIRE) -- GNT Pharma Inc. announces that the independent data monitoring committee (IDMC) for ENIS-3 (Efficacy and safety of Nelonemdaz for Ischemic Stroke) has completed a pre-specified interim analysis encompassing 227 acute ischemic stroke patients treated with placebo or nelonemdaz within 8 hours of onset in China. The IDMC concluded that the ENIS-3 trial should continue as planned without modification. In the prior phase II trial in China (ENIS, 237 patients), administration of nelonemdaz reduced disability primarily in moderate to severe ischemic stroke patients treated with a thrombolytic drug. The ENIS-3 trial was then designed to examine the efficacy and safety of nelonemdaz in 946 patients with moderate to severe acute ischemic stroke treated with tPA within 8 hours of stroke onset. In South Korea, another multicenter, double-blinded phase III trial (RODIN: Rescue on Reperfusion Damage in Cerebral Infarction by Nelonemdaz) has been initiated to further explore the functional and neuroprotection efficacy of nelonemdaz in acute cerebral ischemia and reperfusion, aiming to enroll a total of 496 patients with moderate to severe ischemic stroke who receive endovascular thrombectomy within 12 hours of stroke onset. The RODIN trial has now enrolled more than 224 patients over the last 7 months and is expected to complete enrollment in the middle of 2023. In the prior phase II study published online in the peer-reviewed journal Stroke in September, nelonemdaz treatment was associated with better functional outcomes than placebo in moderate to severe ischemic stroke patients who received endovascular thrombectomy within 8 hours of stroke onset. Good functional outcomes were analyzed by a fraction of 0 (no disability symptoms) – 2 (slight disability, able to look after own affairs without assistance) on the modified Rankin Scale (mRS) and a Barthel index of >90 (functional independence in activities of daily living) at 12 weeks. An mRS score of 0–2 was achieved in 54.1% (33/66) and 63.2% (36/57) patients in the placebo and high-dose groups treated with 5,250 mg nelonemdaz, respectively. The common odds ratio (90% confidence interval) indicating a favorable shift in mRS scores was 1.61 (0.94–2.76) between the placebo and high-dose groups. A Barthel index of >90 was observed in 24 (43.6%) and 34 (63.0%) patients in the placebo and high-dose groups, respectively. An overall trend towards excellent outcome (mRS score of 0 and BI of >90) and reduced mortality at 12 weeks, was observed in the nelonemdaz treatment groups compared to placebo. Dr. Dennis W. Choi, Professor of Neurology, Stony Brook Medicine, and a pioneer in identifying pathological mechanisms of ischemic brain injury said, “Phase III studies of nelonemdaz appear to be progressing well. These trials represent a key shot on the worldwide goal of developing an effective neuroprotective treatment for ischemic stroke.” Nelonemdaz is a multi-target neuroprotectant acting as both a moderate NR2B-selective N-methyl d-aspartate (NMDA) receptor antagonist and a potent spin trapper that ameliorates both fast NMDA receptor-mediated neuronal death and the delayed free-radical mediated brain cell degeneration occurring hours-to-days after ischemic stroke. In animal models of stroke, superior safety and efficacy was observed for nelonemdaz treatment compared with NMDA antagonists or antioxidants alone. In prior phase I and phase II studies, administration of nelonemdaz was well-tolerated, with no appearance of the psychotic symptoms seen in humans exposed to previous NMDA receptor antagonist drugs. “Recent advances in recanalization therapy remarkably improve functional outcomes after acute ischemic stroke and open up new opportunities for neuroprotection therapy based on early delivery and reperfusion,” said Dr. Byoung Joo Gwag, founder and CEO of GNT Pharma. “Nelonemdaz is safe and shows promising efficacy profiles in patients receiving thrombolytic or endovascular therapy. When combined with recanalization therapies, nelonemdaz will hopefully break new ground in treating ischemic brain injury, reducing consequent disability and mortality.” About nelonemdaz Nelonemdaz is a breakthrough multi-target neuroprotectant drug candidate, acting both as a moderately powerful, NR2B subtype-selective NMDA receptor antagonist, and a powerful antioxidant. It is designed to safely ameliorate NMDA receptor-mediated excitotoxicity while also reducing free radical toxicity, two major routes of brain cell death after stroke. About the phase II ENIS Results In China, a phase II study of nelonemdaz (ENIS trial) has been completed in acute ischemic stroke patients receiving a thrombolytic drug within 8 hours of stroke onset (n=237). Administration of nelonemdaz for 5 days was well-tolerated and showed promising efficacy in moderate to severe stroke patients with initial National Institutes of Health Stroke Scale (NIHSS) scores of ≥6 on admission. The fraction of recovery to normal in placebo-treated group was 13%, 16%, and 26% at 14 days, 30 days, and 90 days, respectively, which improved to 25%, 34% and 44% in the group treated with high dose nelonemdaz. About the phase II SONIC Results In South Korea, a phase II, double-blind, randomized, placebo-controlled, multi-center study (SONIC trial) has been conducted to assess the safety and efficacy of nelonemdaz in acute ischemic stroke patients treated with endovascular recanalization within 8 hours of stroke onset. SONIC enrolled 208 acute ischemic stroke patients with NIHSS score of ≥8. Patients randomly received infusions of placebo, 500 mg nelonemdaz (low-dose group), or 750 mg nelonemdaz (high-dose group) prior to thrombectomy. Low-dose and high-dose nelonemdaz groups then received 9 consecutive infusions of 250 mg and 500 mg every 12 hours, respectively. The primary outcome was the percentage of patients achieving at least a good functional outcome 12 weeks later. Good functional outcome was defined as 0 (no disability symptoms) – 2 (slight disability, able to look after own affairs without assistance) on the modified Rankin Scale (mRS), the most widely used outcome measure in stroke research. In the full analysis set encompassing 183 patients, an mRS score of 0–2 at 12 weeks was achieved in 54.1% (33/66), 61.5% (40/65), and 63.2% (36/57) patients in the placebo, low-dose, and high-dose groups, respectively. In secondary outcomes, the common odds ratio (90% confidence interval) indicating a favorable shift in mRS scores at 12 weeks was 1.55 (0.92–2.60) between the placebo and low-dose groups and 1.61 (0.94–2.76) between the placebo and high-dose groups. A Barthel index of >90 (functional independence in activities of daily living) at 12 weeks was observed in 24 (43.6%), 34 (54.8%), and 34 (63.0%) patients in the placebo, low-dose, and high-dose groups, respectively. An overall trend towards excellent outcome (mRS score of 0 and BI of >90) and reduced mortality at 12 weeks, was observed in the nelonemdaz treatment groups compared to placebo. No serious adverse events were observed in nelonemdaz treatment groups. The SONIC trial results have been published in the journal Stroke in September. About the phase III ENIS-3 Trial Based upon the encouraging results observed in the ENIS trial, Apeloa Pharmaceutical of Hengdian Group, GNTP’s Chinese partner, initiated in December 2020 an ongoing phase III study of nelonemdaz in 948 patients with moderate to severe (9≤NIHSS≤22) acute ischemic stroke (ENIS III), engaging 40 Chinese university stroke centers. All patients receive a thrombolytic drug tPA prior to administration of placebo or nelonemdaz within 8 hours of stroke onset. About the phase III RODIN Trial In September 2021, the Korea Ministry of Food and Drug Safety (MFDS) approved an Investigational New Drug Application (IND) for a phase III study of nelonemdaz in acute ischemic stroke patients (RODIN trial). RODIN is designed to investigate the safety and efficacy of 5,250 mg nelonemdaz in 496 patients with severe ischemic stroke receiving endovascular thrombectomy within 12 hours of stroke onset. Patients will be enrolled at 23 university stroke centers and evaluated by mRS, NIHSS, BI, and MRI over 90 days following stroke. At present, RODIN has enrolled 224 patients at 21 university stroke centers including Seoul Asan Medical Center. About GNT Pharma: GNT Pharma was founded in April 1998 by eight professors in the fields of neuroscience, pharmacology, medicinal chemistry, psychology, ophthalmology, and cell biology who had all been investigating mechanisms of neuronal cell death. Since then, GNTP has discovered and developed several innovative drug candidates for the treatment of nervous system disorders such as stroke and Alzheimer’s disease. Disclosure Notice This press release includes forward-looking statements about GNT Pharma’s efforts to treat acute ischemic stroke and the investigational anti-stroke drug nelonemdaz that are based on management’s beliefs and assumptions, expectations, estimates, and projections as well as facts and factors currently known by GNT Pharma. Statements included in this release that are not historical data and facts, including the words “plans”, “expects”, or similar expressions and statements constitute forward-looking statements. Such statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed in these forward-looking statements. Risks and uncertainties include those associated with the impact COVID-19 could have on our business, and including but not limited to, those inherent in research and development, including completion dates of clinical trials, final data from clinical trials, and the regulatory process. You are cautioned not to rely on these forward-looking statements as there are important factors that could cause actual results to differ materially from forward-looking statements. GNT Pharma undertakes no obligation to update forward-looking statements. Contacts 1. Eun Chan Park, PhD (US Office): ecpark@gntpharma.com (1-848-228-6841) 2. Chang Geun Kim, PhD: cgkim@gntpharma.com (+82-70-4261-0786) 3. Byung Chul Kim, Public Relations Director: bckim@gntpharma.com (+82-70-4262-4755)