ד"ר פאלק פארמה ו-Allianthera (Suzhou) Biopharmaceuticals יוצרות שותפות אסטרטגית לפיתוח אגוניסט AhR חדשני

פרייבורג (גרמניה), סוג'ואו (סין) ובוסטון (ארה"ב), 30 ביולי 2025:

Dr. Falk Pharma GmbH ו-Allianthera (Suzhou) Biopharmaceuticals Co., Ltd. מכריזות על שותפות אסטרטגית לפיתוח אגוניסט AhR חדשני לטיפול בקוליטיס כיבית בינונית עד חמורה.

Dr. Falk Pharma GmbH, חברת תרופות מבוססת מחקר המתמחה ברפואת עיכול ומטבולית, Allianthera (Suzhou) Biopharmaceuticals Co., Ltd., וחברת הבת שלה Allianthera Boston, Inc., חברת ביוטכנולוגיה בשלב קליני המתמקדת במחקר ופיתוח תרופות חדשניות באימונולוגיה ומחלות דלקתיות, (Allianthera), שמחות להודיע על חתימת הסכם על פיתוח משותף, אפשרות רישיון, ייצור ומסחור של המולקולה הקטנה החדשה ATB102, אגוניסט קולטן פחמימנים אריל (AhR) שנמצא כעת בניסוי קליני שלב 1 בארצות הברית.

Dr. Falk Pharma and Allianthera (Suzhou) Biopharmaceuticals Forge Strategic Partnership for Novel AhR Agonist Development

Freiburg (Germany), Suzhou (China) and Boston (USA), July 30, 2025:

Dr. Falk Pharma GmbH and Allianthera (Suzhou) Biopharmaceuticals Co., Ltd. Announce Strategic Partnership to Develop a Novel AhR Agonist for the Treatment of Moderate to Severe Ulcerative Colitis

Dr. Falk Pharma GmbH, a research-based pharmaceutical company specializing in digestive and metabolic medicine, Allianthera (Suzhou) Biopharmaceuticals Co., Ltd., and its affiliate Allianthera Boston, Inc., a clinical stage biotechnology company focusing on novel drug research and development in immunology and inflammatory diseases, (Allianthera), are pleased to announce the signing of an agreement on the co-development, license option, manufacturing, and commercialization of the novel small molecule ATB102, an aryl hydrocarbon receptor (AhR) agonist currently undergoing a phase 1 clinical trial in the United States.

Under the terms of the newly signed agreement, Dr. Falk Pharma and Allianthera will collaborate to develop ATB102 for inflammatory bowel disease (IBD), with an initial focus on refractory moderate-to-severe ulcerative colitis (UC). Dr. Falk Pharma will enjoy the exclusive rights to license, manufacture, and commercialize ATB102 worldwide, excluding Mainland China, Hong Kong, Macau and Taiwan. As part of the agreement, Allianthera will receive a signing fee, significant development milestone payments as well as a licensing fee, followed by sales milestone payments and tiered royalties.

ATB102, developed by Allianthera, is a gut-enriched AhR agonist which represents a new therapeutic approach for IBD. It is designed to specifically target inflammation and mucosal damage within the gastrointestinal tract, with a particular emphasis on treating refractory moderate-to-severe UC. In pre-clinical research, ATB102 supports immune homeostasis, restores mucosal barrier integrity, and confers anti-fibrotic and anti-oxidative benefits, making it a potential new option for patients unresponsive to or relapsed from existing therapies.

Dr. Falk Pharma, in cooperation with its fully-owned subsidiary Losan Pharma GmbH, a leading contract development and manufacturing organisation (CDMO) partner and formulation expert, will develop an innovative colonic-release formulation of ATB102 to complement the current immediate release formulation.

“The aryl hydrocarbon receptor represents a truly novel mechanism of action to address the significant unmet needs in inflammatory bowel disease - especially in ulcerative colitis. The ATB team has discovered what we believe to be the best-in-class AhR agonist optimized for safety, gut enrichment, and therapeutic impact. We are delighted to join forces with Dr. Falk Pharma, who has deep expertise in formulation and clinical development. By combining our complementary strengths, we are confident that we will accelerate this program and deliver a much-needed, high-quality therapy to patients faster than ever before,” said Yuanhua Ding, CEO of Allianthera.

Kai Pinkernell, M.D., Managing Director, Science & Innovation at Dr. Falk Pharma, added, “We are excited about the addition of ATB102 to our R&D pipeline and to further exploring the potential of this novel molecule in future clinical trials together with Allianthera. The partnership with Allianthera reflects the strength of scientific excellence, mutual trust and a shared vision to better the lives of patients suffering from IBD. This collaboration not only reflects our growing global development and commitment to innovation in areas of high unmet medical need, it will also enhance Dr. Falk Pharma´s portfolio to treat digestive diseases and conditions.”

About Ulcerative Colitis

Ulcerative colitis is one of the disorders known as inflammatory bowel disease (IBD). Other disorders within this group of conditions include Crohn’s disease and two forms of microscopic colitis, called lymphocytic and collagenous colitis.

Ulcerative colitis is confined to the colon and typically begins in the rectum, spreading continuously throughout the rest of the large intestine. The exact cause of ulcerative colitis is still unclear; however immune system dysfunction, genetic factors, gut microbiome imbalance and dysregulation of the intestinal mucosal integrity as well as environmental factors are currently being investigated as potential contributors.

For more information, visit Dr. Falk Pharma’s website: https://drfalkpharma.com/en/indications/ulcerative-colitis/

About Allianthera

Allianthera was established in November 2020 with a research and development (R&D) center in Suzhou, China, and a subsidiary in Boston, USA. Allianthera strives to become a global leader in therapeutic innovation by combining their deep disease biology knowledge and industry-leading R&D expertise with partners’ technologies while leveraging unique strengths in different geographies, East or West. The company is building a strong portfolio through internal R&D programs and external partnerships with an initial focus on diseases with unmet medical needs in immunology and inflammatory diseases.

Further information on Allianthera can be found on LinkedIn: https://www.linkedin.com/company/allianthera-suzhou-biopharmaceutical-co-ltd

About partnering with Dr. Falk Pharma

Dr. Falk Pharma engages in a variety of collaboration and partnership models to develop and deliver innovative treatment concepts with great potential. These treatments can be based on any type of pharmacological approach, from small molecules to biologics to novel drug delivery technologies. The company is involved in partnership projects across the range of phases and partners, from all stages of pre-clinical/clinical development and marketing as well as with academic researchers, start-ups, and established companies.

Dr. Falk Pharma is an industry leader in innovative pharmaceutical formulations that deliver active substances to specific functional segments of the gastrointestinal tract. Many of their products have attained standard-of-care status. The company enjoys strong, long-standing collaborations with renowned clinical centres and with academic and clinical key opinion leaders in the fields of gastroenterology, hepatology and metabolic diseases.

For more information go to https://drfalkpharma.com/en/partnering/

About Dr. Falk Pharma GmbH

Dr. Falk Pharma GmbH has been developing and marketing innovative medicines to treat a wide range of gastrointestinal disorders like inflammatory bowel disease or eosinophilic esophagitis as well as hepatobiliary disorders such as primary biliary cholangitis for over 60 years. As the international experts in digestive and metabolic medicine, the company brings together physicians, scientists, and patients to devise new and powerful approaches to patient care. Dr. Falk Pharma engages in pre-clinical and clinical stage research that aims to meaningfully improve therapeutic practice as well as patient health and well-being. A family-owned business with a global presence, Dr. Falk Pharma has ten affiliates in Europe and Australia and is continuously growing. The company has its headquarters and R&D facilities in Freiburg, Germany, its pharmaceutical products are manufactured in Europe, mainly at sites in Germany, France, Italy and Switzerland. Dr. Falk Pharma employs approximately 1400 individuals globally and 340 in Freiburg.

Further information on Dr. Falk Pharma can be found online: https://drfalkpharma.com

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