Simnotrelvir/Ritonavir

New York, NY, and Tel Aviv, ISRAEL, Nov. 29, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today announced that its majority-owned subsidiary 3CL Pharma was awarded oral and poster presentations at World Antiviral Congress 2022. Oral Presentation Details: Title: Showcase 6: Mechanism based designed 3CL inhibitors. From HRV to Covid19 Date: 30th of November, 2022 Time: 3:45pm PT Room: Commodore A & B Loews Coronado Bay Resort, San Diego Poster Presentation Details: Title: NLC-V (Tollovir™) as an Adjunctive Therapy in Hospitalized Patients Diagnosed with COVID-19: A Phase 2 Randomized, Double-Blind, Placebo-controlled Trial Date: 30th of November 2022 Exhibition Hall Loews Coronado Bay Resort To learn more about the 3CL protease in SARS-CoV-2 replication, please visit . To purchase Tollovid please visit Amazon or . About Todos Medical Ltd. Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that examines cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos’ two internally developed cancer-screening tests, TMB-1 and TMB-2 have received a CE mark in Europe. Todos recently acquired U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing, Long COVID Panel analyses, and Provista's proprietary commercial-stage Videssa® breast cancer blood test. More information on Provista is available at . Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain. Todos formed the Israeli-based majority-owned joint venture 3CL Pharma, Ltd with NLC Pharma in March of 2022 to consolidate all of the intellectual property surrounding 3CL protease–based diagnostic testing and development of 3CL protease botanical and pharmaceutical inhibitors that target a fundamental reproductive mechanism of coronaviruses. 3CL Pharma, through Todos’ brand, has commercialized the 3CL protease inhibitor immune support dietary supplement Tollovid™ in the United States, is developing the dual mechanism 3CL protease inhibitor and anti-cytokine therapeutic drug candidate Tollovir™, while also developing the 3CL protease diagnostic TolloTest™. To purchase Tollovid please visit Amazon or . For more information, please visit . Forward-looking Statements Certain statements contained in this press release may constitute forward-looking statements. For example, forward-looking statements are used when discussing our expected clinical development programs and clinical trials. These forward-looking statements are based only on current expectations of management, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for product candidates; competition from other biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from the competition; and laboratory results that do not translate to equally good results in real settings, all of which could cause the actual results or performance to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Todos Medical does not undertake any obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Todos Medical, please refer to its reports filed from time to time with the U.S. Securities and Exchange Commission. Todos Corporate Contact: Daniel Hirsch CFO Todos Medical 917-983-4229 x 104 Dan.h@todosmedical.com Todos Press Contact: Giancarlo Greager TreviPR 702-768-1906 giancarlo@trevipr.com

NANJING, China, Sept. 5, 2022 /PRNewswire/ -- Simcere Pharmaceutical Group Limited (2096.HK) announced its financial results for the first half of 2022. As of June 30, Simcere recorded operating revenue of RMB 2.7 billion for the first half of the year, with a year-over-year growth of 27.3%. The estimated net profit for the first half of 2022 after deducting non-recurring profits and losses would be RMB 390 million. Innovative drug revenue grew 44.8% year-over-year to RMB 1.767 billion, accounting for a record-high 65.4% of total revenue. Simcere has transformed into an innovative pharmaceutical company that relies on innovation and R&D for performance growth. According to the report, Simcere Pharmaceutical currently has 6 branded innovative drug products on the market. In the two years since its launch, Sanbexin® (Edaravone and Dexborneol concentrated solution for injection), Simcere's innovative drug for stroke, has benefited 860,000 patients nation-wide, driving a 74.7% year-over-year revenue growth of the CNS portfolio and further improving Simcere's leading market position in this field. Moreover, revenue contribution from products such as Enweida® (Envafolimab injection), the world's first subcutaneous PD-(L) 1 antibody, further validated Simcere's business capabilities. Under the R&D strategy of "focusing on more effective therapies and emphasizing differentiation", the company is currently fast-tracking nearly 60 innovative drug pipeline projects and conducting 20 registered clinical studies on 16 potential innovative drugs. 7 projects have entered Phase 3 clinical trials, including 2 highlighted candidates, Sanbexin sublingual tablets, and SIM0417, an investigational anti-SARS-CoV-2 drug. The Sanbexin sublingual tablets (oral formulation of Edaravone and Dexborneol), an innovative drug currently being developed at phase 3 clinical study, offers anti-inflammatory and anti-free radical effects together with blood-brain barrier protection to minimize brain cell damage caused by stroke. The administration of sublingual tablet is not restricted by medical institution capabilities or patient compliance, making it suitable for various conditions of acute or chronic CNS diseases. It is expected to form a sequential regimen with Sanbexin® injection. At present, patient enrollment of 914 subjects have been completed for the product's pivotal Phase 3 trial within just 10 months ahead of schedule. Simcere is going to expedite its NDA in China in the near term. Market analysis revealed that the drug would quickly achieve peak sales after reaching the market owing to Simcere Pharmaceutical's long-standing CNS market share. The scarcity of innovative CNS drugs in China also increases Simcere's investment value. SIM0417, another important product being developed by Simcere, is an anti-SARS-CoV-2 candidate that targets 3CL, a key protease essential for virus replication, and has shown good antiviral activity against a variety of strains. Preclinical studies have shown that some of the SIM0417 efficacy and safety metrics are better than those of molecules having similar biological targets currently on the market. As of the announcement date, Simcere Pharmaceutical has been conducting two Phase2/3 clinical trials of SIM0417 combined with Ritonavir versus placebo for antiviral treatment in COVID-19 patients, and for post-exposure prophylaxis for close contacts of individuals who test positive for COVID-19 throughout several provinces and cities in accordance with the clinical trial protocol approved by CDE(Center for Drug Evaluation). During the persistent epidemic and recurrent outbreaks, there is a significant unmet need for the prevention and treatment of COVID-19 close contacts. As a small molecule drug and oral tablet, SIM0417 has inherent advantages in responding to the pandemic due to its convenience in storage, transportation, and administration. As a result of Simcere's efforts combining in-house R&D with extensive R&D collaborations, the business development has contributed tremendously to the company's pipeline. On July 12, 2022, Simcere received conditioned approval for its first-in-class innovative drug Cosela® (Trilaciclib hydrochloride for injection), developed through licensing–in collaboration. Cosela® is the world's first myelo-protection drug that prevents damage of bone marrow stem cells from cytotoxic chemotherapy. The successful development of this drug took only 708 days from the date of license-in agreement signing till market approval in China. According to published industrial data, among the top 100 license-in products in China between 2019 and 2021 in terms of transaction amount, only 4 products are approved with new indications on the Chinese market. In this list, Trilaciclib takes the first place for fast development in China, nearly shortens the time frame by a year compared to the product ranked second. As one of the first pharmaceutical companies in the industry to complete innovation transformation, the advantages of Simcere's differentiated R&D capabilities, manufacturing capacities benchmarked against international metrics, and leading business capabilities, are gradually emerging. The innovative drug R&D pipelines have started to pay off, allowing Simcere to launch more differentiated innovative drugs more efficiently and successfully while expanding its business capabilities. Since the successful IPO on the Hong Kong Stock Exchange in 2020, Simcere Pharmaceutical's innovative drug business has become a major driver for the company's continued growth. According to the outlook section in the announcement, Simcere will fast-track its Sanbexin sublingual tablet R&D process to complete its pivotal phase 3 clinical trials, actively explore possible new indications of Cosela, and expedite the R&D of anti-SARS-CoV-2 drug SIM0417. As the national bulk-buy program bringing heavy impact to the pharmaceutical industry, Chinse companies are turning their focused on differentiated innovation. Simcere chooses a unique approach to innovation based on its continuous R&D investment, diversified and differentiated pipelines, and proven business capabilities. These efforts will provide driven force for future growth and development. About Simcere Simcere Pharmaceutical Group Limited (2096.HK) is a pharmaceutical company driven by innovative R&D and committed to synergistic innovation. It has established the State Key Laboratory of Translational Medicine and Innovative Drug Development and currently boasts four R&D centers in Nanjing, Shanghai, Boston and Beijing. With the commitment to "providing today's patients with medicines of the future" the Company focuses on three therapeutic areas: oncology central nervous system diseases and autoimmune diseases while actively expanding its strategic presence in prospective disease areas with significant clinical needs in the future. Simcere now has six global first-in-class innovative drugs and is holding leading market shares for its key products in China with its excellent R&D and commercialization capabilities. Its vigorous in-house R&D efforts and extensive R&D collaborations have made it a strategic cooperation partner with international and domestic leading innovative pharmaceutical enterprises medical institutions and research institutes. SOURCE Simcere Pharmaceutical Group Limited