Somatropin biosimilar (Dong-A ST Co., Ltd.)

-Therapeutic equivalence and safety confirmed between DMB-3115 and Stelara in global phase III SEOUL, South Korea--(BUSINESS WIRE)-- Dong-A ST (President/CEO Min-young Kim, KRX:170900) announced on July 14 that the European Medicine Agency (EMA) confirmed acceptance of Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (Ustekinumab). Accord, a wholly owned subsidiary of Intas Pharmaceuticals Ltd, submitted the MAA to EMA on June 23rd, and the EMA accepted the MMA submission on July 14th in CET. The MAA submission is based on the results of an extensive analytical similarity assessment of DMB-3115 with that US and EU-sourced STELARA using current ‘state-of-the-art’ methods. The MAA submission also comprised the results from the phase III multi-regional clinical trials in patients with plaque psoriasis (NCT04785326). The primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. As a result, the therapeutic equivalence between DMB-3115 and the reference product was verified, and no safety issues were observed. DMB-3115 is a proposed biosimilar to Stelara®, a blockbuster drug developed by Janssen Biotech Inc., and for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It recorded 17.77 billion USD (IQVIA Accumulative Sales in 2022) and is one of the best-selling biologics. Dong-A Socio Holdings and Meiji Seika Pharma began joint development for DMB-3115 in 2013, and the rights for R&D and commercialization were transferred to Dong-A ST in July 2020 for efficient project management. Since then, Dong-A ST and Meiji Seika Pharma worked together to develop the drug. In July 2021, the worldwide distribution rights, excluding Japan, South Korea, and certain Asian regions, were licensed to Intas Pharmaceuticals, a multinational pharmaceutical company. Intas Pharmaceuticals will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada. “We are delighted to reinforce our partnership with Dong-a & Meiji for Accord Healthcare to global rights to this critical drug, reinforcing our commitment to improving access to high-quality biosimilar drugs for patients globally,” said Mr. Paul Tredwell, Executive Vice President of Accord Healthcare. “We will spare no effort to ensure DMB-3115 is supplied to the global market by leveraging a strong partnership between Dong-A, Meiji, Intas, and Accord,” said Mr. Jaehong Park, President & CSO (Chief Science Officer) of DongA ST.

Currently the Only Long-Acting Growth Hormone Demonstrates Superior Annualized Height Velocity Compared to Daily hGH in Children with Growth Hormone Deficiency SHANGHAI, Nov. 17, 2022 /PRNewswire/ -- VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, today released for the first time detailed clinical data from its pivotal Phase 3 study of lonapegsomatropin, a long-acting prodrug of unmodified somatropin being investigated as a once-weekly injection in children with growth hormone deficiency (GHD) in China. The data showed that lonapegsomatropin demonstrated an annualized height velocity (AHV) of 10.66 cm/year compared to 9.75 cm/year for the daily hGH at 52 weeks (treatment difference at 0.91 cm/year with a 95 percent confidence interval: 0.37 – 1.45 cm/year, p=0.0010), reaching its primary objective, demonstrating that lonapegsomatropin is non-inferior to the daily hGH. Further analysis showed that lonapegsomatropin had superior efficacy to the daily hGH. Multiple pre-set sensitivity analyses validated the robustness of these results. During this trial, lonapegsomatropin was well tolerated with a safety profile comparable to daily hGH. Currently, most of the commercially available growth hormone therapies in China are in the form of short-acting daily injections. Lonapegsomatropin is in development in Greater China through license from Ascendis Pharma and uses Ascendis Pharma's innovative TransCon[1] (Transient Conjugation) technology. When injected, physiologic conditions in the body initiate the release of the active, unmodified somatropin in a predictable manner at a predetermined rate, releasing predictable levels of somatropin over the course of the week. VISEN's pivotal Phase 3 trial was a randomized, open-label, active-controlled trial with children suffering from growth hormone deficiency in China led by Professor Luo Xiaoping as the principal investigator, the Deputy Director of the Pediatrics Commission of China Medical Association and Director of the Pediatrics Department at Tongji Hospital affiliated to the Huazhong University of Science and Technology. Elaborating on the clinical trial data, Professor Luo Xiaoping further commented: "The AHV was significantly higher for lonapegsomatropin than for the daily hGH from week 13 onward. Height standard deviation score (SDS) [2]at 52 weeks increased over baseline by 1.01 for lonapegsomatropin and by 0.83 for the daily hGH (p=0.0015). In addition, the improvement of height SDS in the lonapegsomatropin group is more significant from week 13 onward. Over 52 weeks of treatment, insulin-like growth factor-1 (IGF-1) generally increased into the normal range and mean average IGF-1 SDS values in the lonapegsomatripin group was greater than daily rhGH. IGF-1 is a polypeptide produced by the liver in response to GH, and its physiological role is mainly to stimulate chondrocyte proliferation, differentiation, and collagen synthesis[3]. The augmentative/counteractive system of GHIGF augments the anabolic action of GH while attenuating the potentially undesirable GH effects of gluconeogenesis and lipolysis[4]." Pony LU, CEO and Executive Director of VISEN Pharmaceuticals, said: "According to publicly available data of marketed products in China, lonapegsomatropin is currently the only long-acting growth hormone demonstrated superiority to the daily treatment with the growth hormone somatropin. The pivotal 52-week data released today from the China Phase 3 clinical trial demonstrated head-to-head that once-weekly lonapegsomatropin is non-inferiority and superior to daily hGH. The results are consistent with Ascendis Pharma's global pivotal Phase 3 heiGHt Trial, and we look forward to offering a new long-acting growth hormone treatment option for Chinese patients." Lonapegsomatropin is globally developed by Ascendis Pharma A/S, who received U.S. Food and Drug Administration (FDA) and the European Commission (EC) approval for lonapegsomatropin in pediatric growth hormone deficiency in August 2021 and January 2022, respectively. About VISEN Pharmaceuticals VISEN is an innovative biopharmaceutical company focused on endocrine diseases. We are dedicated to providing innovative therapies and compassionate, patient-centric care, because we believe that achieving better treatment processes and outcomes results in living better lives. Putting patients' need first, VISEN is committed to providing first-in-class or best-in-class products and treatments for endocrine diseases. Our therapeutic areas cover endocrine diseases in adults and children, and rare endocrine diseases. VISEN comprises seasoned professionals with multinational pharmaceutical experiences and leverages cutting-edge technologies and leading resources across the world. We are focused on the Chinese market, and have established offices in Shanghai, Beijing, Hong Kong and Taipei. We have also launched our Greater China R&D and Manufacturing Campus in Suzhou to enhance R&D, manufacturing and commercialization efforts. Our goal is to enable Chinese endocrine patients to benefit from the world's most advanced and reliable treatment solutions earlier. For more information, please visit our website: SOURCE VISEN Pharmaceuticals