Androgen-Insensitivity Syndrome

SHANGHAI, Dec. 14, 2023 /PRNewswire/ -- The Japan-based Global Health Innovative Technology Fund (GHIT Fund) announced today that it will invest approximately US$3.3 million (approximately 500 million yen[1]) in a global multicenter Phase III clinical trial project (the "Program") led by Fosun Pharma for a triple artemisinin combination drug (Artemether-Lumefantrine-Amodiaquine fixed-dose formulation) against malaria in Africa and Southeast Asia, to accelerate the development and commercialization of this new drug. The Project will be jointly conducted by Fosun Pharma, a major Chinese pharmaceutical and healthcare company, Marubeni, a leading Japanese integrated trading and investment business conglomerate, a Thailand-based research collaboration of universities, Mahidol-Oxford Tropical Medicine Research Unit (MORU), and the product development partnership Medicines for Malaria Venture (MMV), which provides technical support and market access expertise. This is the first time GHIT Fund has invested in a research project led by a Chinese pharmaceutical company. This drug candidate should have a significant public health benefit as it is expected to play an important role in the fight against artemisinin partial resistance (ART-R) which is now observed widely in the Greater Mekong Subregion (GMS) of Southeast Asia[2] and to some extent in several African countries, including Rwanda and Uganda. Importantly, the project includes the development of a co-formulated child-friendly version, given that most malaria cases are in children[3]. Malaria is an infectious parasitic disease transmitted by mosquitos that affects approximately 250 million people annually and was responsible for approximately 620,000 deaths in 20213. Infection in the African region constitutes 95% of the total global malaria cases, and children under the age of 5 account for 80% of all malaria deaths in this region. The GHIT Fund invests in innovative drug development with the aim of contributing to global health through facilitating collaboration between Japanese and global institutions' technology and innovation to address these neglected infectious diseases. Wen Deyong, CEO of Fosun Pharma, said, "We are very pleased to work with GHIT Fund to promote the clinical research on this antimalarial innovator drug. The collaboration will accelerate the launch of this new drug so as to actively respond to the threat of artemisinin partial resistance and partner drug resistance of Plasmodium falciparum parasites and save more lives from malaria. Fosun Pharma is committed to further improving the accessibility and affordability of antimalarial drugs through continuous innovation and our global operational capabilities, so as to continuously strive for a malaria-free world." Dr. Osamu Kunii, CEO of the GHIT Fund, said "We are very excited to have Marubeni and FOSUN PHARMA as our new product development partners. It is an important step forward to invest in the development of antimalarial drugs in late-phase clinical trials to advance commercialization. The number of malaria cases and deaths in children under 5 years old is an urgent issue. This investment will make a significant contribution to reducing the burden of malaria globally, especially among young children." The antimalarial drug independently developed by Fosun Pharma has been used to treat more than 60 million patients with severe malaria worldwide The artemisinin based antimalaria medicines originated from China have made significant contributions to global malaria prevention and control. In Sub-Saharan Africa alone, about 240 million people benefit from artemisinin-based combination therapies every year. The artesunate for injection (Artesun®) independently developed by Fosun Pharma is the first-line treatment of severe malaria for both adults and children recommended by the WHO since 2011. It has become a well-known Chinese innovator drug in Africa and the world. So far, Artesun® has been used to treat more than 60 million patients with severe malaria worldwide, most of whom were African children under five years old. In June 2023, the second-generation artesunate for injection (Argesun®) independently developed by Fosun Pharma was prequalified by the WHO (WHO-PQ), becoming the first injectable artesunate presented with a single solvent system approved by WHO-PQ. It greatly improves the convenience of clinical use and is particularly practicable for remote areas in Africa with backward medical conditions to save more lives. Up to now, the product has been registered and marketed in 18 countries. The deployment of Fosun Pharma's new generation Argesun® has further improved the accessibility of high-quality antimalarial innovator drugs in Africa, providing a convenient solution for primary medical institutions to treat sever malaria patients and save lives. Fosun Pharma was therefore recognized on Fortune 2023 China's Most Admired Company List. Effectively reduce the incidence rate of severe malaria in children from treatment to prevention As an innovation-driven global pharmaceutical and health industry group, Fosun Pharma has independently developed innovative antimalarial products covering malaria prevention and treatment, as well as the rescue of critically ill patients. From "treatment" to "prevention", Fosun Pharma continues to provide more prevention and treatment solutions for malaria patients, especially children. In August 2018, Fosun Pharma's SPAQ-CO® Disp (co-packed sulfadoxine-pyrimethamine dispersible tablets and amodiaquine dispersible tablets), for the prevention of malaria in children, was prequalified by WHO. Fosun Pharma has actively carried out community-oriented "Child Malaria Prevention Knowledge Popularization Projects" in 14 malaria-endemic countries in Africa. These projects aim to enhance local awareness of malaria prevention among African populations, thus helping to reduce the incidence of malaria and interrupt community transmission of the disease. By the end of June 2023, more than 245 million children in Africa had benefited from the "Seasonal Malaria Chemoprevention Program", for which SPAQ-CO® Disp is used as the core drug, effectively reducing the incidence of malaria in children under five years old in Africa. About GHIT Fund The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma will uphold the development model of "Innovation Transformation, Integrated Operation and Steady Growth", with the mission of creating shareholder values through strengthening its independent R&D and external cooperation and enriching its product pipelines, as well as promoting the global networks and enhancing operational efficiency. Fosun Pharma will actively promote the digital and physical business layout in the pharmaceutical and healthcare industry and is committed to becoming a first-class enterprise in the global pharmaceutical and healthcare markets. For more information, please visit our official website: . SOURCE Fosun Pharma

First investment in a Japanese trading company and a Chinese pharma company. Accelerating new drug development by investing in late-phase clinical trials. TOKYO, Dec. 13, 2023 /PRNewswire/ -- The Global Health Innovative Technology (GHIT) Fund announced today an investment of approximately 1.3 billion yen (US$8.8 million1) for the development of new drugs for malaria and Chagas disease.2 Malaria is an infectious parasitic disease transmitted by mosquitos that affects approximately 250 million people annually and was responsible for approximately 620,000 deaths in 2021.3 The African region constitutes a staggering 95% of global malaria cases, and children under the age of 5 account for 80% of all malaria deaths in this region. The GHIT Fund invests in new product development with the aim of contributing to global health by facilitating collaborations between Japanese technology and innovation and global institutions to address these neglected infectious diseases. This is the first investment by the GHIT Fund in a general trading company, Marubeni Corporation (Marubeni), and a pharmaceutical company in China, Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd. (FOSUN PHARMA), with the aim of accelerating the development of new drugs by focusing on investments in late-phase clinical trials. First investment in a Japanese trading company and a Chinese pharma company — new malaria drug in a phase III trial by Marubeni, Fosun Pharma, MORU, and MMV The GHIT Fund will invest approximately 500 million yen (US$3.3 million1) in a clinical phase III trial for a triple artemisinin combination drug against malaria, in partnership with a leading Japanese integrated trading and investment business conglomerate, Marubeni, a major Chinese pharmaceutical and health care company, FOSUN PHARMA, a Thailand-based research collaboration of universities, Mahidol-Oxford Tropical Medicine Research Unit (MORU), and the product development partnership Medicines for Malaria Venture (MMV), which provides technical support and market access expertise. This drug candidate should have a significant public health benefit as it is expected to play an important role in the fight against artemisinin partial resistance (ART-R), which is now observed widely in the Greater Mekong Subregion (GMS) of Southeast Asia4 and to some extent in several African countries, including Rwanda and Uganda. Importantly, the project includes the development of a co-formulated child-friendly version, given that most malaria cases are in children.3 800-million-yen investment in a phase IIb study of the new anti-malarial drug candidate SJ733 as a radical cure for P. vivax The GHIT Fund will also invest approximately 800 million yen (US$5.4 million1) in the anti-malarial drug project by Eisai Co., Ltd. and the University of Kentucky to develop a radical cure for P. vivax malaria. SJ733, an antimalarial drug candidate, has completed a Phase IIa trial for single administration and has shown efficacy and tolerability against P. vivax malaria. With this new investment, the project aims to shorten the treatment period by using SJ733 in combination with the existing drug tafenoquine. Dr. Osamu Kunii, CEO of the GHIT Fund, said "We are very excited to have Marubeni and FOSUN PHARMA as our new product development partners. It is an important step forward to invest in the development of antimalarial drugs in late-phase clinical trials to advance commercialization. The number of malaria cases and deaths in children under 5 years old is an urgent issue. This investment will make a significant contribution to reducing the burden of malaria globally, especially among young children." In addition, the GHIT Fund will invest approximately 16 million yen (US$0.1 million1) in Nagasaki University and Drugs for Neglected Diseases initiative (DNDi) for a screening project against Chagas disease, which is one of the neglected tropical diseases. As of December 14, 2023, there are 50 ongoing projects, including 19 discovery projects, 18 preclinical projects and 13 clinical trials5 in the GHIT Fund's portfolio. The total amount of investments since 2013 is 31.6 billion yen (US$211 million). The GHIT Fund is a Japan-based international public-private partnership (PPP) fund that was formed between the Government of Japan, multiple pharmaceutical companies, the Bill & Melinda Gates Foundation, Wellcome, and the United Nations Development Programme (UNDP). The GHIT Fund invests in and manages an R&D portfolio of development partnerships aimed at addressing neglected diseases, such as malaria, tuberculosis, and neglected tropical diseases, which afflict the world's vulnerable and underserved populations. In collaboration with global partners, the GHIT Fund mobilizes Japanese industry, academia, and research institutes to create new drugs, vaccines, and diagnostics for malaria, tuberculosis, and neglected tropical diseases. Appendix 1. Project Details G2022-205 G2022-218 S2023-121 *All amounts are listed at an exchange rate of USD1 = JPY149.52, the approximate exchange rate on October 31, 2023. Appendix 2. Investment Overview (as of December 14, 2023) Investments to date Total investments: 31.6 billion yen (US$211 million1) Total invested projects: 123 (50 active projects and 73 completed projects) To learn more about GHIT Fund's investments, please visit Investment Overview: Portfolio: Advancing Portfolio: Clinical Candidates: For more information, contact: Katy Lenard at +1-301-280-5719 or [email protected] Mina Ohata at +81-36441-2032 or [email protected] SOURCE GHIT Fund

BRONX, N.Y., Sept. 7, 2023 /PRNewswire/ -- In findings with potentially important implications for cervical cancer screening, scientists at the National Cancer Institute (NCI)-designated Montefiore Einstein Cancer Center (MECC) have developed a test for detecting a type of cervical cancer that Pap tests often miss. The findings published online today in the Journal of the National Cancer Institute (JNCI). "Our novel test appears sensitive for detecting cervical adenocarcinoma [ADC]—which now accounts for up to 25% of cervical cancer cases—as well as its precursor lesions, adenocarcinoma in situ [AIS], that often develop into ADCs," said Howard Strickler, M.D., M.P.H., co-senior and corresponding author of the JNCI paper and a member of MECC. "Because ADCs are often missed by current screening methods, they have higher mortality rates than the more common cervical squamous cell cancer," Dr. Strickler added. "Our goal is to catch the disease early, before it develops into cancer." Dr. Strickler is also professor and head of the division of epidemiology and the Harold and Muriel Block Chair in Epidemiology and Population Health at Albert Einstein College of Medicine. A Novel Approach to Testing The widespread use of the Pap test, in which a pathologist examines tissue samples for abnormal cells, has significantly reduced the incidence of cervical squamous cell cancer over the past six decades. However, the incidence of ADC has not decreased, probably because the Pap test is less effective at detecting it. In recent years, testing for human papillomaviruses (HPVs)—which cause virtually all cases of cervical cancer—joined the Pap test as a standard screening tool for cervical cancer. Although there are more than 100 types of HPV, three types—HPV 16, 18, and 45—account for more than 70% of all cervical cancer cases and more than 90% of ADC cases. The current HPV tests cover all three types and can alert infected women that they face a high risk for developing cervical cancer. While vaccines for preventing cervical cancer—including Gardasil-9, which protects against nine HPV types—are safe and effective, several generations of women are above the age for receiving the vaccine. Therefore, screening and treatment for prevention of cervical cancer will remain critical for decades to come. The MECC-developed HPV test assessed HPV 16, 18, and 45 in a novel way: by specifically looking at methylation levels. "The advent of next-generation genetic testing has opened up opportunities for us to more accurately detect oncogenic HPV strains and patterns in the genomes that correspond with the development of AIS and ADC," said Robert D. Burk, M.D., professor of pediatrics, of microbiology & immunology, of epidemiology and population health, and of obstetrics & gynecology and women's health at Einstein and MECC member, who co-led the study. Methylation—the addition of methyl (CH3) groups to a region of DNA—is a routine occurrence in DNA, both viral and human, and plays a critical role in altering gene expression. The JNCI study, a collaborative project with the NCI, part of the National Institutes of Health, investigated methylation levels in cervical tissue samples from 1,400 women who had undergone cervical cancer screening at Kaiser Permanente Northern California before 2014 and whose cervical cancer status was known. In assessing the HPVs in the cytological samples, the researchers tallied up the methylation percentages for each of 35 different viral-genome sites, with each sample receiving a final "methylation score" equal to the average methylation percentage across all 35 sites. Those women with methylation scores in the upper 25% had very high odds for having developed either ADC or AIS. "Our findings, if confirmed by clinical trials, suggest that women with a high methylation score may benefit from colposcopy and specialized tissue evaluation, beyond just a Pap test, which could lead to early diagnosis and treatment for ADC or the removal of AIS lesions before they develop into ADC," said Dr. Burk. Improving Equity in Cervical Cancer Screening "Given that our test uses equipment that could be simplified, it has the potential to expand testing in lower-resourced countries," said Dr. Strickler, who has long studied HPV in women living with HIV, who are more likely to acquire an HPV infection. Cervical cancer remains the fourth most common type of cancer in women, with the burden significantly higher in lower- and middle-income countries, including those in Sub-Saharan Africa, where HIV-HPV coinfections are common. There are also significant disparities within the United States. In New York City, rates of cervical cancer in the Bronx, which is home to the poorest urban congressional district in the country, are 50% higher than in Manhattan. More frequent and effective screening could help address this health disparity. "Ideally, the new HPV methylation test would only need to be done once every three to five years," said Dr. Strickler. "We are hopeful that this test will be able to increase cervical cancer screening equity in the U.S. as well." The paper is titled "A Novel HPV/Host DNA Methylation-Score and Detection of Cervical Adenocarcinoma." In addition to Drs. Strickler and Burk, other Einstein authors on the study were Ana Gradissimo, Ph.D., Xiaonan Xue, Ph.D., and Philip E. Castle, Ph.D, M.P.H. (also affiliated with the NCI). Other contributors were Megan A. Clarke, Ph.D., M.H.S., Mark Schiffman, M.D., M.P.H., and Nicolas Wentzensen, M.D., Ph.D., M.PH., all at NCI, and Tina R. Raine-Bennett, M.D., M.P.H. at Kaiser Permanente. About Montefiore Einstein Cancer Center Montefiore Einstein Cancer Center (MECC) is a national leader in cancer research and care located in the ethnically diverse and economically disadvantaged borough of the Bronx, N.Y. MECC combines the exceptional science of Albert Einstein College of Medicine with the multidisciplinary and team-based approach to cancer care of Montefiore Health System. Founded in 1971 and a National Cancer Institute (NCI)-designated Cancer Center since 1972, MECC is redefining excellence in cancer research, clinical care, education and training, and community outreach and engagement. Its mission is to reduce the burden of cancer for all, especially people from historically marginalized communities. SOURCE Montefiore Einstein Cancer Center