Humanitas SpA

SHANGHAI, June 28, 2023 /PRNewswire/ -- Recently, Henlius successfully held its first Overseas Scientific Advisory Board (SAB) meeting of 2023 in California, United States. The gathering brought together leading experts in the fields of biotechnology, pharmacology, oncology, and immunology to discuss the latest scientific findings, medical needs, Henlius' R&D pipeline, technology platform layout, and future strategic plans. The meeting was held in a hybrid format, incorporating both in-person and virtual participation. Henlius' SAB members including Professor Christopher Garcia from Stanford University School of Medicine, members of the National Academy of Science and the National Academy of Medicine; Professor Alberto Mantovani, a renowned scholar researching inflammation-cancer connection, Scientific Director and Emeritus Professor at Humanitas Clinical and Research Center in Italy; Professor Abul K. Abbas, a Distinguished Professor and former Chair of the Department of Pathology at the University of California, San Francisco (UCSF), and Professor David R. Gandara, Professor Emeritus and Co-director of the Centre for Experimental Therapeutics at the University of California Davis Comprehensive Cancer Centre, along with scientists from Henlius' innovation centres in China and the United States, attended the meeting. Dr. Qiang Liu, head of the company's US Innovation Centre, delivered the opening remarks on behalf of the company, warmly welcoming the distinguished guests. Following that, Dr. Yongqiang Shan, general manager of Shanghai Innovation Centre, provided an overview and summary of the company's recent research progress and strategic ambitions. The company's strategic development strategy was discussed by Arthur Sheng, general manager of Global Strategy and PMO. Scientific advisors and Henlius' scientists engaged in in-depth discussions regarding novel approaches to oncology immunotherapy, new targets, and cutting-edge technology platforms, the progress of projects that in the stage of early drug discovery, covering scientific rationale, competitive landscapes, the latest research data, and future plans. The SAB members also provided constructive feedback regarding the prioritization of research projects, the selection of disease areas, the allocation of research resources, team building, and mechanisms of action. Henlius is dedicated to addressing unmet medical needs by constructing a network through SAB and engaging in in-depth dialogues with leading scholars in key disciplines. The company aims to gain rich professional insights and guidance. Moving forward, Henlius will continue to focus on developing ground-breaking treatment solutions, enhancing its innovation capabilities and global presence in relevant areas, and ultimately benefiting more patients around the world. About Henlius Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable, and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases, and ophthalmic diseases. Up to date, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, the U.S., and the EU, respectively. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®, the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets. SOURCE Henlius

Overall response rate of 70.1% and complete response rate of 33.3% in heavily pretreated patients; median duration of response of 13.7 months Safety pro consistent with prior findings Preparing for potential submission of a Biologics License Application to the FDA Cami data and diffuse large B-cell lymphoma posters to be presented today at the European Hematology Association 2022 Hybrid Congress LAUSANNE, Switzerland--(BUSINESS WIRE)-- ADC Therapeutics SA (NYSE: ADCT) announced today results from the ongoing pivotal Phase 2 clinical trial of camidanlumab tesirine (Cami) in relapsed or refractory (r/r) Hodgkin lymphoma. An overall response rate (ORR) of 70.1% and a complete response (CR) rate of 33.3% was observed with a median duration of response of 13.7 months for all responders in r/r Hodgkin lymphoma patients who were refractory or had relapsed after a median of 6 prior treatments, including brentuximab vedotin (BV) and a PD-1 blockade. The safety pro Cami was substantially consistent with previously reported interim findings. The results will be presented today during an oral session at the European Hematology Association 2022 Hybrid Congress (EHA2022). The Phase 2 single-arm, multicenter, open-label clinical trial is evaluating Cami in 117 patients with r/r Hodgkin lymphoma who have received ≥3 prior lines of treatment (≥2 lines if ineligible for hematopoietic stem cell transplantation, HSCT). Patients received a median of 6 prior lines of systemic therapy. “Cami has demonstrated consistently favorable response rates and durability in Hodgkin lymphoma patients who have relapsed, despite using the best available treatments. These results offer hope to patients and doctors who need a new option,” said Joseph Camardo, MD, Chief Medical Officer of ADC Therapeutics. “With these data from our Phase 2 trial in hand, we look forward to scheduling a meeting with the FDA to discuss the potential submission of a Biologics License Application.” Data to be presented at EHA2022 by Carmelo Carlo-Stella, MD, Department of Biomedical Sciences, Humanitas University, and Department of Oncology and Hematology, IRCCS Humanitas Research Hospital in Milan, Italy, include: ORR of 70.1% and CR rate of 33.3% in patients with a median of 6 prior treatments Median duration of response (DOR) was 13.7 months and median progression-free survival (PFS) was 9.1 months; patients who achieved a CR had a median DOR of 14.5 months 14 patients received HSCT following treatment with Cami The most common grade ≥3 treatment-emergent adverse events in ≥5% of patients were: thrombocytopenia (9.4%), anemia (8.5%), hypophosphatemia (7.7%), neutropenia (7.7%), maculopapular rash (6.8%) and lymphopenia (5.1%) 8/117 patients developed Guillain-Barré syndrome/polyradiculopathy. GBS symptoms could be mitigated with careful medical intervention. “Very few viable or sustainable treatment options are available for patients with Hodgkin lymphoma who are refractory or relapse following treatment with brentuximab vedotin and PD-1 inhibitor therapy,” said Dr. Carlo-Stella. “Results from the pivotal Phase 2 trial indicate Cami, a novel CD25-targeted ADC, has the potential to fill the need for a new treatment option for heavily pretreated patients with Hodgkin lymphoma.” In addition, the following three posters will be presented at EHA2022 today from 16:30 – 17:45 CEST / 10:30 a.m. – 11:45 a.m. EDT in Hall D: Health-Related Quality Of Life And Tolerability Of Loncastuximab Tesirine In High-Risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated In A Phase 2 Clinical Trial (LOTIS 2) Abstract Code: P1717 Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Patients Who Received Car-T Therapy Abstract Code: P1182 Real-World Characteristics And Clinical Outcomes In Relapse/Refractory Diffuse Large B-Cell Lymphoma Post Car-T Failure Abstract Code: P1181 About Camidanlumab Tesirine (Cami) Camidanlumab tesirine (Cami) is an antibody drug conjugate (ADC) comprised of a monoclonal antibody that binds to CD25 (HuMax®-TAC, licensed from Genmab A/S), conjugated to the pyrrolobenzodiazepine (PBD) dimer payload, tesirine. Once bound to a CD25-expressing cell, Cami is internalized into the cell where enzymes release the PBD-based payload, killing the cell. This applies to CD25-expressing tumor cells and also to CD25-expressing Tregs. The intra-tumoral release of its PBD payload may also cause bystander killing of neighboring tumor cells, and PBDs have also been shown to induce immunogenic cell death. All of these properties of Cami may enhance immune-mediated anti-tumor activity. Cami is being evaluated in a pivotal Phase 2 clinical trial in patients with relapsed or refractory Hodgkin lymphoma and a Phase 1b clinical trial as monotherapy and in combination with pembrolizumab in solid tumors. About ADC Therapeutics ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs). The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors. ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large b-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents. Cami (camidanlumab tesirine) is being evaluated in a pivotal Phase 2 trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors. In addition to ZYNLONTA and Cami, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development. ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit and follow the Company on Twitter and LinkedIn. ZYNLONTA® is a registered trademark of ADC Therapeutics SA. Forward-Looking Statements This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business and commercialization strategy, market opportunities, products and product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, projected revenues and expenses and the timing of revenues and expenses, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. View source version on businesswire.com: Contacts Investors Eugenia Litz ADC Therapeutics Eugenia.Litz@adctherapeutics.com +44 7879 627205 Amanda Hamilton ADC Therapeutics amanda.hamilton@adctherapeutics.com +1 917-288-7023 Media Mary Ann Ondish ADC Therapeutics maryann.ondish@adctherapeutics.com +1 914-552-4625 Source: ADC Therapeutics View this news release online at:

SHANGHAI and BOSTON, March 22, 2021 /PRNewswire/ -- Citrine Medicine, a China-based rare disease therapeutics company, today announced that it has received a clinical trial waiver from the National Medical Products Administration (NMPA) in China for Wakix® (pitolisant), a narcolepsy drug approved in the European Union and the United States for the treatment of narcolepsy in adult patients with and without cataplexy. The company also announced, during a ceremony that took place during Sleep Awareness Week, that its holding company the RareStone Group has signed a five-year strategic partnership with the Chinese Alliance for Rare Diseases (CARD), a non-profit organization promoting the development of rare disease therapies and treatment access in China. Together, these efforts support Citrine's efforts to build the first rare disease ecosystem in China. The clinical trial waiver enables Citrine to accelerate its efforts to bring Wakix to patients in need. Wakix is approved by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) to treat adults suffering from narcolepsy, a serious, chronic disorder characterized by excessive daytime sleepiness (EDS), with or without cataplexy. The clinical trial waiver enables Citrine to submit a New Drug Application (NDA) using data from the U.S. and Europe. As part of the strategic partnership, Citrine will work closely with CARD to promote advances in rare disease prevention, diagnosis, and treatment. The partnership will include rare disease research collaborations; the establishment of a patient registry; rare disease education projects and collaborations; the establishment of rare disease expert panels; and the launch of rare disease-focused conferences in China. "Together, the clinical trial waiver for Wakix and our new partnership with CARD represent a significant step forward in our efforts to build Citrine into a leading rare disease platform company in China," said Melissa Bradford-Klug, Citrine's chief business officer and U.S. president. "The clinical trial waiver will vastly increase the speed at which we can bring Wakix to patients with narcolepsy, and provides important validation of our business model and our platform. We founded Citrine to build a rare disease ecosystem in China and bring much-needed drugs to patients affected by rare and orphan diseases. We thank our founding investors, F-Prime Capital, Vivo, and Eight Roads, for their continued support of our business model and platform, and look forward to working with the NMPA, as well as with physicians, patients, and families affected by narcolepsy, to bring Wakix and other important rare and orphan disease therapies to the Chinese market." "We are incredibly impressed by the speed that Citrine is moving towards bringing Wakix to patients," said Dandan Dong, Ph.D., a managing director at Vivo Capital and member of Citrine's Board of Investors. "After closing their Series A financing round late last year, the Citrine team is making incredible progress in their efforts to build a rare disease ecosystem to benefit patients and families in China." About Citrine Medicine Citrine Medicine is dedicated to improving the lives of patients with rare and intractable diseases by making diagnosis and essential treatments available and accessible to those who need them in China. Our mission is to build the first rare disease ecosystem in China and in doing so, enable people with rare diseases to live more normal lives. In addition to developing and marketing rare disease drugs, Citrine aims to establish a patient-centric platform which educates people on rare diseases, trains doctors on diagnosis and treatment, and helps doctors develop a full disease management protocol. Citrine's lead product candidate, Wakix® (pitolisant), is an investigational oral drug in development for the treatment of narcolepsy and obstructive sleep apnea in China. Citrine has initiated an Investigational New Drug (IND) submission for pitolisant in the treatment of narcolepsy and expects to complete the IND submission in the first quarter of 2021. Citrine also recently announced a strategic partnership that will allow the company exclusive rights to develop, register, and commercialize Alkindi®—the first clinically validated pediatric treatment for congenital adrenal hyperplasia—in the Greater China market. Citrine is a subsidiary of RareStone Group, and is headquartered in Shanghai and has other offices in Beijing, China and Cambridge, Mass. For more information, visit About CARD CARD is a national, non-profit, cooperative exchange platform for rare disease therapy development, supported by Peking Union Medical College Hospital, PhiRDA, the Chinese Medical Association, the Chinese Hospital Association and the Chinese Research Hospital Association, as well as multiple universities, scientific research institutes and enterprises. About Eight Roads Eight Roads is a global proprietary investment firm backed by Fidelity. The flexible nature of its capital means Eight Roads can back and build innovative and ambitious businesses looking to disrupt or lead their chosen markets. Eight Roads has over 20 years of venture capital experience in China and has supported over 100 companies in the country's healthcare and technology sectors. In the past 10 years, the Eight Roads ecosystem has invested almost $6 billion USD globally. About Vivo Capital Founded in 1996, Vivo Capital is a global investment firm focused on healthcare. Vivo has approximately $4.3 billion in assets under management, invested in over 250 public and private companies worldwide. Vivo provides a multi-fund investment platform, covering growth equity, private equity including buyout, venture capital, and public equity. The firm is headquartered in Palo Alto, California, with additional offices in Asia. About F-Prime Capital F-Prime Capital is a global venture capital firm investing in healthcare and technology. For the past 50 years, our independent venture capital group has had the privilege of backing great entrepreneurs building groundbreaking companies. With over two billion dollars under management and a global portfolio of more than 200 companies, we champion those dedicated to creating positive change in the world. F-Prime is headquartered in Cambridge, MA, with offices in London, UK and San Francisco, CA. About Pitolisant Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist which enhances the activity of histaminergic neurons. The drug was approved by the EMA in 2016 for the treatment of narcolepsy in adults with or without cataplexy and is marketed in major countries in Europe and was approved by the FDA in 2018. Cataplexy is characterized by sudden and uncontrolled muscle weakness or paralysis. Pitolisant has an orphan designation in the EU and the US for the treatment of narcolepsy. The drug pitolisant is distributed under the tradename WAKIX® in the European Union and the United States for the treatment of narcolepsy in adult patients with and without cataplexy. About Narcolepsy Narcolepsy is a rare, chronic, debilitating neurological disorder characterized by excessive daytime sleepiness, cataplexy, a sudden loss of muscle control triggered by emotions, and hallucinations among other symptoms. Two types of narcolepsy are currently recognized according to the ICSD3 diagnostic criteria, Type 1 and 2. Type 1 is associated with cataplexy and a reduction in of hypocretin-1 levels, while Type 2 is not associated with cataplexy. Important Safety Information In clinical trials conducted in patients with narcolepsy, the most frequent adverse drug reactions (ADRs) reported with pitolisant were insomnia (8.4%), headache (7.7%), nausea (4.8%), anxiety (2.1%), irritability (1.8%), dizziness (1.4%), depression (1.3%), tremor (1.2%), sleep disorders (1.1%), fatigue (1.1%), vomiting (1.0%), vertigo (1.0%), dyspepsia (1.0%), weight increase (0.9%), and upper abdominal pain (0.9%). Pitolisant is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and in women breastfeeding their children. Citrine Medicine Media Contacts: Sarah Sutton Finsbury Glover Herring sarah.sutton@fgh.com 202-337-0808