Yunding Xinyao Pharmaceutical Technology Co., Ltd.

SHANGHAI, Nov. 29, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that its New Drug Application (NDA) for Nefecon® has been accepted for review by South Korean's Ministry of Food and Drug Safety (MFDS) for the treatment of primary immunoglobulin A nephropathy (IgAN) in adult patients. Nefecon® was the first ever targeted treatment for IgAN approved in the United States, European Union and China. Everest expects to receive NDA approval in South Korea in 2024. "Everest is committed to expanding Nefecon® regulatory approvals across our licensing territories as IgAN is most prevalent in East Asian population and people of Pacific Asian origin has a significantly increased risk of progressing to end-stage renal disease," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "While we look forward to the imminent launch of this first-in-disease therapy in China, where disease prevalence is approximately five million IgAN patients, we also aim to quickly bring Nefecon® to patients throughout Asia including Singapore, Hong Kong, Taiwan and South Korea over the next year to meet urgent needs for innovative therapies like Nefecon® that target disease origin and can delay disease progression." South Korea's MFDS granted Global Innovative product on Fast Track (GIFT) designation to Nefecon® earlier this year. Nefecon® was the second product and the first non-oncology product included in MFDS' GIFT program. Inclusion in the GIFT program is expected to accelerate regulatory review time by 25% and allow for rolling review. The Phase 3 NefIgArd clinical trial, a randomized, double-blind, multicenter study, evaluated the efficacy and safety of Nefecon® at a once-daily dose of 16 mg, compared to placebo, in adult patients with primary IgAN on optimized RASi therapy. The NefIgArd study is a 2-year trial, which consisted of nine months of treatment with Nefecon® or placebo, followed by a 15-month follow-up period off study drug. The primary endpoint, time-weighted average of eGFR over 2 years, showed a statistically significant and clinically meaningful benefit of Nefecon® over placebo (p-value < 0.0001). It also showed a difference in 2-year total eGFR slope of 2.95 mL/min per 1.73 m2 per year in favor of Nefecon®. The data reflected treatment benefits across the entire study population, regardless of UPCR baseline level. The full two-year results of the NefIgArd trial (n=364 patients) were further analyzed to assess potential differences in response to Nefecon® treatment based on self-reported Asian (n=83) or White (n=275) ancestry in patients with IgAN. Treatment with Nefecon® 16 mg/day over a 9-month period resulted in clinically meaningful preservation of kidney function in both subgroups, as evidenced by reduction in proteinuria and stabilization of eGFR in these two subgroups when compared to placebo. About Nefecon® Nefecon® is a patented oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. The formulation is designed as a delayed release capsule that is enteric coated so that it remains intact until it releases budesonide to the distal ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum where the disease originates, as per the predominant pathogenesis models. In June 2019, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize Nefecon® in Mainland China, Hong Kong, Macau, Taiwan and Singapore. The agreement was extended in March 2022 to include South Korea as part of Everest Medicine's territories. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. SOURCE Everest Medicines

STOCKHOLM, Oct. 27, 2023 /PRNewswire/ -- Calliditas Therapeutics AB(Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas") today announced that its commercial partner Everest Medicines (HKEX 1952.HK) ("Everest") received approval from the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China. The approval for Nefecon is for the treatment of primary immunoglobulin A nephropathy (IgAN) in adults at risk of disease progression. Macau is the first region in Everest territories that received Nefecon approval. The NDA for Nefecon in mainland China is under Priority Review and Nefecon was the first non-oncology medicine to receive Breakthrough Therapy Designation in China. Nefecon has been available for clinical use in Shanghai Ruijin Hospital's Hainan subsidiary through an early-access program since April 2023. CONTACT: For further information, please contact: Åsa Hillsten, Head of IR & Sustainability, Calliditas Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com The information was sent for publication, through the agency of the contact persons set out above, on October 27, 2023 at 09:15 a.m. CET. The following files are available for download: View original content: SOURCE Calliditas Therapeutics Company Codes: Stockholm:CALTX, NASDAQ-NMS:CALT, Bloomberg:CALT@US, Bloomberg:CALTX@SS, ISIN:SE0010441584, RICS:CALT.A, RICS:CALTX.ST

SHANGHAI, Sept. 27, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Taiwan Food and Drug Administration (TFDA) has approved the New Drug Application (NDA) for XERAVA® (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). "The NDA approval of XERAVA® in Taiwan marks an important step towards bringing this novel, critical therapy for complicated intra-abdominal infections and other life-threatening infections to more patients in Asia," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "Following the successful commercial launch of XERAVA® in mainland China and Singapore, we will accelerate patient access to this product in more markets including Hong Kong and Taiwan." XERAVA® was approved by the National Medical Products Administration ("NMPA") of China in March 2023 and commercially launched in July. It has also been approved and commercialized in Singapore. XERAVA® has been recommended by multiple treatment guidelines in China and globally, based on its broad bacterial spectrum coverage and high potency against multidrug-resistant bacterial infections. Everest entered into an exclusive partnership agreement with TTY Biopharm (TTY) in 2022 for commercialization of XERAVA® in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin). About XERAVA® (eravacycline) XERAVA® (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative, Gram-positive and anaerobic pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. XERAVA® is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK, Singapore, mainland China, Hong Kong, and Taiwan. XERAVA® was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. SOURCE Everest Medicines