Zeria Pharmaceutical Co., Ltd.

Veltassa® offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients 1-5 Zeria Pharmaceutical Co., Ltd. to market Veltassa® in Japan ST. GALLEN, Switzerland, Sept. 24, 2024 /PRNewswire/ -- CSL Vifor today announced that Japan's Ministry of Health and Labor Welfare (MHLW) has granted its partner, Zeria Pharmaceutical Co., Ltd. (Zeria), marketing authorization approval for Veltassa® for the treatment of adult patients with hyperkalemia, a condition characterized by high levels of potassium in the blood. Veltassa® has now received marketing authorizations in 41 countries worldwide. "We are pleased that Veltassa® has been approved in Japan, and congratulate our trusted partner Zeria," said Hervé Gisserot, General Manager of CSL Vifor. "This milestone reflects our shared commitment to addressing the needs of over 300,000 patients in Japan affected by hyperkalemia6, particularly those with chronic kidney disease or heart failure. As we continue to deliver on our promise, we are excited to introduce a next generation hyperkalemia management therapy, designed to be broadly utilized across diverse patient groups." The approval is based on the marketing authorization application filing by Zeria, which was supported by positive clinical data from the Japanese clinical development program of ZG-801 (Veltassa®) conducted in patients with hyperkalemia in Japan. In 2018, CSL Vifor granted Zeria the exclusive right to develop and market Veltassa® in Japan. Zeria expects to begin to market Veltassa® following National Health Insurance price listing. About CSL Vifor CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries. For more information about CSL Vifor visit, . About hyperkalemia Hyperkalemia is a serious condition in which the amount of potassium in the blood exceeds the normal level (between 3.5 and 5.0 mmol/L)7. Usually, hyperkalemia remains asymptomatic. However, when the levels of potassium are very high or increase rapidly, people may experience heart palpitations, shortness of breath, chest pain, nausea, or vomiting 8, 9. The most common causes of high potassium include chronic kidney disease (CKD) and heart failure (HF). Medications used to delay progression of HF and CKD – renin-angiotensin aldosterone system inhibitor (RAASi) – may as well increase the risk of hyperkalemia10. About Veltassa® (patiromer) Veltassa® is a sodium-free exchange potassium binder which reduces high amounts of potassium in the blood and maintains the potassium at a normal level. Veltassa® acts within the gastrointestinal tract by exchanging potassium for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process. Veltassa® enables patients to manage chronic hyperkalemia, permitting them to stay on optimal and guideline-recommended doses of life-saving RAASi medications. Veltassa® has demonstrated to enable optimized RAASi therapy use across a range of placebo-controlled, randomized clinical trials in a variety of patient profiles 2,3,11. As of September 2024, Veltassa® has been approved in 41 countries worldwide, including in the U.S. and the EU. References: CSL Vifor Media Contact Thomas Hutter +41 79 957 96 73 [email protected] Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

NEWARK, DE, USA I June 12, 2024 I Mage Biologics announces it has dosed the first study participant in a first-in-human study of MB-001, a best-in-class orally administered antibody designed for the treatment of inflammatory bowel disease (IBD). The trial is a randomised, double-blind phase 1 study to assess the safety and pharmacokinetics of single and multiple ascending doses of MB-001 in adult healthy volunteers (NCT06363383). Mage plans to complete the study in the first half of 2025. Johannes Spleiss, CEO of Mage, commented: “We are excited to have been able to move MB-001 into the clinic in a very short period of time and are grateful for the strong support of the experienced Tillotts team that enabled us to quickly produce GMP-grade material for this novel delayed- and sustained-release formulation. Despite more options today for patients with IBD, there still remains a need for safe and highly effective treatments, particularly for the elderly. MB-001 offers the potential to be such an option either as a stand-alone therapy or in combination with current treatments.” Alimentiv, a specialty GI-focused clinical research organisation (CRO) specialised in clinical trial delivery, medical imaging solutions and precision medicine services, provided an excellent project team with deep gastrointestinal expertise that seamlessly integrated into our newly created organisation. Mage Biologics also engages with Chorus, a full-service autonomous research and development unit within Eli Lilly and Company, to support an innovative clinical plan in collaboration with an international network of ulcerative colitis (UC) experts. About ulcerative colitis UC is an inflammatory bowel disease (IBD) that impacts millions of people worldwide. UC affects the innermost lining of the colon and the rectum, causing inflammation and ulcers in the digestive tract. In most people, symptoms usually develop over time, taking a relapsing-remitting course, which means that periods of flare-ups are followed by periods of remission. This can be draining and, in some cases, lead to life-threatening complications. While there is no known cure, current treatments aim to reduce signs and symptoms of the disease and bring remission. Over the last decade, biologics have gained an important place in the treatment of UC, with several monoclonal antibodies available as subcutaneous or intravenous therapies approved for use in UC. Unfortunately, a substantial proportion of patients do not respond, lose response or develop intolerance to currently marketed products, leading to a substantial unmet medical need for safer, effective and more convenient therapeutic options. About MB-001 MB-001 is a best-in-class orally administered, humanised antibody formulation designed for targeted release in the inflamed mucosa, optimal tissue penetration by active receptor-mediated transport, improved potency compared to systemically applied antibodies and optimised receptor interaction by a modified glycosylation pattern. The drug was designed to exert its action in the inflamed tissue with minimal systemic uptake. About Mage Biologics Inc Mage Biologics is a special purpose company created to develop a novel, orally administered monoclonal antibody to clinical proof of concept for the treatment of UC. Mage Biologics is jointly funded by TVM Life Science Innovation II and Tillotts Pharma, and is led by an experienced management team. About Tillotts Pharma Tillotts Pharma AG, part of the Japanese Zeria Group, is a fast-growing specialty pharma company with close to 400 employees in Switzerland and abroad. Tillotts is dedicated to the development, acquisition and commercialisation of innovative pharmaceutical products for the digestive system. Tillotts successfully markets its own products for the treatment of IBD and Clostridioides difficile infection (CDI) as well as in-licensed products in around 65 countries through its affiliates within Europe and a network of partners throughout the world. Visit: www.tillotts.com . About TVM Capital Life Science TVM is a leading international venture capital firm focused on investing in life sciences innovations. The company has a highly experienced transatlantic investment team and approximately $900m under management. TVM’s portfolio focuses on therapeutics and medical technologies from North America and the EU that represent differentiated first-in-class or best-in-class assets with the potential to transform standard of care. TVM pursues a unique two-pronged strategy, financing innovative early-stage therapeutics through a single asset company approach (Project-Focused Company, PFC) that leverages the firm’s strategic relationship with global pharmaceutical firm, Eli Lilly and Company. TVM also invests in differentiated commercial-stage medical technologies and late clinical-stage therapeutics. The TVM investment team has worked together for over a decade to effectively utilise this innovative approach to maximise returns for investors and finance new therapies and technologies to meaningfully improve patient lives. Visit: https://tvm-capital.com . SOURCE: Mage Biologics

June 5, 2024 - In a significant development for the pharmaceutical industry, Zelgen Biopharmaceuticals has announced the submission of a Biologics License Application (BLA) to the National Medical Products Administration (NMPA) for its self-developed injectable recombinant human thyroid-stimulating hormone (rhTSH). The product is currently awaiting formal acceptance for review. The submitted application targets an important indication - the use of rhTSH in radioactive iodine (131I) whole-body scanning (WBS) and serum thyroglobulin (Tg) testing for follow-up of differentiated thyroid cancer patients who have undergone prior thyroidectomy. This represents an unmet need in the Chinese market, as no recombinant human thyroid-stimulating hormone has yet been approved for this specific application. The announcement has been welcomed by the market, with Zelgen Biopharmaceuticals's stock price soaring over 60% since its February low. This milestone marks the company's fourth product to reach the New Drug Application (NDA) stage, underscoring its robust pipeline and innovative capabilities. Thyroid cancer is on the rise globally, and the unique advantages of thyroid-stimulating hormone in cancer management make this a highly promising market opportunity. Currently, only Sanofi's Thyrogen, a recombinant human TSH, is approved in the United States, while the original Thyrogen has faced manufacturing challenges in gaining approval in mainland China. Zelgen Biopharmaceuticals's rhTSH and Suntory Biotech's SNA001 (approved in April 2024) are the two domestic players in the Chinese rhTSH market. Notably, the companies have chosen different initial indications, with SNA001 focusing on thyroid cancer treatment and Zeria's rhTSH targeting post-surgical diagnostic applications. This strategic positioning helps mitigate competitive risks in the emerging market. With the submission of the BLA and the positive results from its Phase III ZGTSH004 trial, Zelgen Biopharmaceuticals is well-positioned to capitalize on the growing demand for innovative thyroid cancer management solutions in China. The company's pipeline and stock performance suggest more exciting developments are in store for the industry and investors alike.