GAITHERSBURG, Md., April 18, 2024 /PRNewswire/ -- YS Biopharma Co., Ltd. (Nasdaq: YS) ("YS Biopharma" or the "Company"), a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and delivering new generations of vaccines and therapeutic biologics for infectious diseases and cancer, today announced that its YS-HBV-002 immunotherapeutic vaccine, designed to treat patients suffering from chronic hepatitis B virus ("HBV") infection, has been granted clinical trial approval by the Philippine Food and Drug Administration ("PFDA"). In light of the approval, the Company is preparing to initiate a Phase I clinical trial for YS-HBV-002 in the Philippines, which is expected to begin in June 2024. Chronic HBV infection is a major global health concern, with an estimated 254 million people suffering from the condition, with 1.2 million new infections each year, according to the World Health Organization (WHO). Those infected are at higher risk for cirrhosis, liver failure, and liver cancer, with between 15%-40% of chronic HBV patients afflicted with one or more of these conditions. In 2022, HBV infection resulted in an estimated 1.1 million deaths, mostly from cirrhosis and hepatocellular carcinoma (primary liver cancer). Chronic HBV infections occur in both developing and developed countries, constituting a significant unaddressed public health threat. At present, the efficacy of existing anti-viral treatment paradigms is limited, and no cure for chronic HBV has yet been developed. Despite the availability of preventive vaccines for hepatitis B infection, there remains an urgent need for effective therapies for individuals who are already infected and have progressed to chronic stages of infection. Dr. David Shao, Director, President, and CEO of YS Biopharma, commented, "The approval of YS-HBV-002 by the Philippines FDA and Ethics Committee represents a significant milestone in our efforts to develop innovative therapies for chronic hepatitis B infection. At present, there is no effective vaccine treatment option for patients suffering from chronic HBV, leaving them at higher risk for other conditions affecting the liver and significantly hampering their quality of life. With our recent approval and upcoming clinical study, we hope to provide these patients with a safe and effective solution to combat this significant unaddressed public health threat. As always, we plan to conduct the clinical trial to the highest safety and ethical standards, and we are eager to take the next step towards delivering these much-needed treatment options to chronic HBV patients." The Phase I clinical trial for YS-HBV-002 will mark an important milestone in addressing this unmet medical need. This trial will employ a double-blind, randomized, placebo-controlled, dose-escalation approach, and aims to evaluate the safety, immunogenicity, and efficacy of YS-HBV-002 among adult patients diagnosed with chronic HBV infection. By targeting both humoral and cellular immune responses, YS-HBV-002 has the potential to disrupt immune tolerance mechanisms and facilitate the treatment of chronic HBV infection in patients. About YS-HBV-002 YS-HBV-002 is a new generation of therapeutic HBV vaccine based on the proprietary technology and clinical results of YS-HBV-001, the first generation of HBV vaccine in the pipeline of YS Biopharma. YS-HBV-002 is formulated with several key components, including recombinant core and surface hepatitis B antigens, and YS Biopharma's proprietary PIKA adjuvant. This carefully designed set of components has the potential to activate both innate and adaptive immune responses in patients, thereby generating a more robust and targeted response to the virus. The re-establishment of a desirable and comprehensive immune response is the first step towards the eradication of chronic HBV infection from the body. About YS Biopharma YS Biopharma is a global biopharmaceutical company dedicated to discovering, developing, manufacturing, and commercializing new generations of vaccines and therapeutic biologics for infectious diseases and cancer. It has developed a proprietary PIKA® immunomodulating technology platform and a series of preventive and therapeutic biologics with a potential for improved Rabies, Coronavirus, Hepatitis B, Influenza, and Shingles vaccines. YS Biopharma operates in China, the United States, Singapore and the Philippines, and is led by a management team that combines rich local expertise and global experience in the bio-pharmaceutical industry. For more information, please visit . Cautionary Statement Regarding Forward-Looking Statements This press release contains "forward-looking statements'' within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical or current fact included in this press release are forward-looking statements, including but not limited to statements regarding the expected growth of YS Biopharma, the development progress of all product candidates, the progress and results of all clinical trials, YS Biopharma's ability to source and retain talent, and the cash position of YS Biopharma. Forward-looking statements may be identified by the use of words such as "estimate," "plan," "project," "forecast," "intend," "will," "expect," "anticipate," "believe," "seek," "target" or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These statements are based on various assumptions, whether identified in this press release, and on the current expectations of YS Biopharma's management and are not predictions of actual performance. YS Biopharma cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of risks and uncertainties, including those included under the heading "Risk Factors" in the Post-effective Amendment No. 2 to the Company's Registration Statement on Form F-1 filed with the SEC on January 23, 2024, and other filings with the SEC. There may be additional risks that YS Biopharma does not presently know or that YS Biopharma currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. The forward-looking statements in this press release represent the views of YS Biopharma as of the date of this press release. Subsequent events and developments may cause those views to change. However, while YS Biopharma may update these forward-looking statements in the future, there is no current intention to do so, except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing the views of YS Biopharma as of any date subsequent to the date of this press release. Except as may be required by law, YS Biopharma does not undertake any duty to update these forward-looking statements. Investor Relations Contact Alyssa Li Director of Investor Relations Email: [email protected] Robin Yang Partner, ICR, LLC Tel: +1 (212) 537-4035 Email: [email protected] SOURCE YS Biopharma Co., Ltd.

临床1期疫苗上市批准免疫疗法

2022-09-08

·BioSpace

YishengBio Received Approvals From Philippines and UAE For Phase 2 / 3 Clinical Trials of PIKA Recombinant COVID-19 vaccine

BEIJING, Sept. 8, 2022 /PRNewswire/ -- YishengBio Co., Ltd., ("YishengBio"), a biopharmaceutical company dedicated to discovery, development, manufacturing and commercialization of new generations of vaccines and therapeutic biologics, announced that the Company received the approvals from the regulatory authorities of United Arab Emirates (UAE) and the Philippines to conduct Phase 2/3 clinical trials for its PIKA recombinant COVID-19 vaccine. The phase 2/3 clinical trials will evaluate the immunogenicity, efficacy and safety of PIKA COVID-19 vaccine as a booster injection among subjects who received 2 or more doses of inactivated COVID-19 vaccine. The trials are designed to be multi-country, multi-center studies with the enrollment of 9,300 participants in UAE, Philippines and Pakistan. PIKA recombinant COVID-19 vaccine is a highly differentiated vaccine candidate with potential prophylactic and therapeutic benefits against COVID-19 infection. PIKA recombinant COVID-19 vaccine is composed of PIKA adjuvant and S protein antigen by using genetic engineering technology with appropriate stabilizer. The pre-clinical studies demonstrated that this vaccine candidate is capable of sustaining two year long of high levels of neutralizing antibodies against a wide range of the variants of the COVID-19 virus, including Omicron BA.2, BA.4/5. Based on the Phase 1 interim results of PIKA COVID-19 vaccine in UAE, the participants who received the low dose of 5 ug per injection were able to achieve high levels of neutralizing antibodies against all currently prevalent SARS-CoV-2 variants, including Omicron BA.2, BA.4/5, both in the prime vaccination regimen and booster dose for subjects who completed 2 doses of inactivated vaccines. PIKA COVID-19 vaccine candidate demonstrated good safety pro phase 1 study. "The initiation of the phase 2/3 clinical trials in multi countries will accelerate the clinical development of PIKA recombinant COVID-19 vaccine candidate to a new level," said Mr Yi Zhang, the Chairman and the Project Leader at YishengBio. "PIKA recombinant COVID-19 vaccine candidate achieved high levels of immunogenicity and broad neutralizing antibodies in clinical trials against wide range of SARS-CoV-2 virus strains, including the most prevalent Omicron variant. This vaccine candidate has the potential to become a universal vaccine against the swiftly mutating SARS-CoV-2 virus worldwide. Equally important, our newly constructed manufacturing plant dedicated to the commercialization of PIKA recombinant COVID-19 vaccine was recently granted the drug manufacturing certificate by the China's National Medical Products Administration (NMPA). We are excited about the initiation of this clinical study and eager to bring this valuable and highly differentiated vaccine to the public health arena to help address critical unmet medical needs." About PIKA Technology: PIKA technology is an immuno-modulating technology platform based on synthetic biologic complex which is originated from Yishengbio's proprietary research and GMP manufacturing engineering process. Through TLR3, RIG-I and MDA-5 signaling pathways, PIKA molecule can induce prompt production of interferon, cytokines, chemokines and co-stimulatory factors. PIKA administration facilitates antigen cross-presentation by dendritic cells and augments CD4+ T-cell, CD8+ T-cell and natural killer-cell responses. When delivered with relevant antigen-based molecules, PIKA technology can be applied to the development of a new generation of antiviral vaccines, antiviral and anticancer therapeutics, offering a promising platform for the development of a wide variety of novel biologics to improve treatments that are currently available and address unmet medical needs. About YishengBio: YishengBio is a biopharmaceutical company dedicated to discovery, development, manufacturing and commercialization of new generation of vaccines and therapeutic biologics for infectious diseases and cancer. YishengBio is expanding its business horizon with a global footprint across various countries, including China, United States, Singapore, the Philippines, Pakistan, the UAE and other countries. The Company has developed proprietary PIKA immunomodulating technology platform which augments both innate and adaptive immune responses through the TLR3, RIG-I and MDA5 pathways. PIKA technology platform has empowered and nurtured a diverse and innovative pipeline of vaccines and therapeutic biologics with differentiated efficacy and safety pro address the unmet medical needs in infectious disease and oncology. YishengBio is one of the leading suppliers of human rabies vaccine in Chinese market and its development pipeline includes PIKA Rabies Vaccine, PIKA recombinant COVID-19 Vaccine, YS-HBV-001, YS-HBV-002 and YS-ON-001 targeting various prophylactic and therapeutic indications. YishengBio is headquartered in Beijing and has over 800 employees in China, U.S.A, Singapore and other countries in Asia. For more information on YishengBio, please visit .

疫苗抗体财报

2021-11-12

·BioSpace

Aligos Therapeutics Presents Data for its Chronic Hepatitis B (CHB) and Nonalcoholic Steatohepatitis (NASH) Portfolio at The Liver Meeting® 2021

Several clinical and nonclinical posters to be presented at the conference Aligos’ capsid assembly modulator (CAM) candidate, ALG-000184, achieved rapid, substantial reductions in hepatitis B virus DNA and RNA in CHB patients after 28 daily doses SOUTH SAN FRANCISCO, Calif., Nov. 12, 2021 (GLOBE NEWSWIRE) -- Aligos Therapeutics Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, will present several poster presentations at The Liver Meeting® 2021, hosted by the American Association for the Study of Liver Diseases (AASLD). All of these posters will also be available on the Aligos website at Scientific Presentations & Conferences as of today and following the conclusion of the conference. “As we continue to progress our pipeline with a multifaceted approach to addressing chronic liver diseases, we are pleased to showcase our progress with posters covering our CHB drugs, including STOPS™, CAM, ASO, and siRNA drug candidates, as well as encouraging results from a preclinical study showing additive to synergistic activity when several of these modalities are combined,” said Lawrence Blatt, Ph.D., MBA, Chairman and Chief Executive Officer of Aligos. “We believe that combining multiple modalities that reduce hepatitis B virus S-antigen together with drugs that inhibit viral replication will be the key to achieving enhanced functional cure rates in people living with CHB.” Dr. Blatt continued, “We are especially pleased to present preclinical data further elucidating the molecular mechanism of action for our STOPS molecules as well as clinical data for our CAM drug candidate, ALG-000184, demonstrating good tolerability and significant reductions in HBV DNA and RNA after 28 days of oral dosing. We are also excited to present our THR-β agonist drug candidate, ALG-055009, that has a favorable preclinical pharmacokinetic pro is supportive of once-daily dosing in humans and appears to have a low risk of drug-drug interactions.” Chronic Hepatitis B S-antigen Transport-inhibiting Oligonucleotide Polymers (STOPS™) Title: S-antigen Transport-inhibiting Oligonucleotide Polymers, (STOPS™) Sequester Cellular Proteins to Reduce Hepatitis B Virus S-Antigen Expression and Increase Its Proteasomal Degradation Publication Number: 845 Session Title: Hepatitis B: Therapeutics: New Agents Presenter: C. Cheng Kao Summary: As part of an in vitro study to elucidate STOPS’ mechanism of action in the context of hepatitis B virus (HBV) infection, five host proteins were identified as binding to STOPS. The proteins are known to be involved in RNA processing, translation, and protein folding and degradation, supporting the premise that STOPS molecules likely inhibit HBV infection and hepatitis B virus surface antigen (HBsAg) production by sequestering host proteins needed to express and properly fold the antigen. STOPS are Aligos’ proprietary single-stranded oligonucleotides that are designed to improve functional cure rates by reducing HBsAg, which is thought to suppress antiviral immune responses in CHB subjects. Capsid Assembly Modulator (CAM) Title: Safety, Pharmacokinetics (PK), and Antiviral Activity of the Capsid Assembly Modulator (CAM) ALG-000184 in Subjects with Chronic Hepatitis B (CHB) Publication Number: 843 Session Title: Hepatitis B: Therapeutics: New Agents Presenter: Ed Gane Summary: ALG-000184 is Aligos’ class II CAM candidate in development to inhibit HBV infection by interfering with HBV capsid assembly and viral replication by causing the formation of non-infectious empty viral particles. As part of the ongoing, three-part, multicenter, double-blind, randomized, placebo-controlled study (NCT04536337), Cohorts 1 and 2 (n=10/cohort; 8 active:2 placebo) of E-antigen (HBeAg)-negative, currently not treated (CNT)/treatment naïve (TN) CHB subjects received 50-mg or 100-mg daily oral doses of ALG-000184 or placebo for 28 days. In both cohorts, ALG-000184 administration was associated with similar rapid, substantial reductions in HBV DNA and RNA through the 28-day period, with ≥75% and 100% of evaluable subjects achieving HBV DNA and RNA reductions below the lower limit of quantitation (LLOQ), respectively. Antisense Oligonucleotide (ASO) Title: Best-in-Class Antisense Oligonucleotides Against Hepatitis B Virus: Next Generation Bridged Nucleic Acid Chemistries Significantly Increase In Vivo Efficacy and Reduce Hepatotoxicity in Mice Publication Number: 820 Session Title: Hepatitis B: Therapeutics: New Agents Presenter: Dinah Misner Summary: Aligos’ application of next-generation Bridged Nucleic Acid (BNA) chemistries to ASO candidates already using Locked Nucleic Acid (LNA) technology stands to yield a best-in-class ASO candidate in terms of efficacy relative to hepatotoxicity. Aligos is advancing ASO drug candidates as part of a combination approach to reducing HBsAg, which suppresses the patient’s antiviral immune response in CHB. Historically, hepatotoxicity has been a major side effect of ASOs; however, next-generation BNA chemistries, when used in ASOs that contain LNA components, can reduce hepatotoxicity while maintaining efficacy. Title: ALG-020572, a GalNAc-Conjugated Antisense Oligonucleotide, Demonstrates In Vivo Efficacy and Favorable Preclinical Pro the Treatment of Chronic Hepatitis B Publication Number: 819 Session Title: Hepatitis B: Therapeutics: New Agents Presenter: Kusum Gupta Summary: Aligos’ ASO therapeutic candidate ALG-020572 was shown to potently inhibit HBsAg in vitro and in vivo. The antiviral activity, hepatocyte targeting and a favorable PK pro ALG-020572 following SC administration warrants its advancement into clinical development as a potential treatment for CHB. siRNA Title: Incorporation of Novel siRNA Chemistries Significantly Improves the Potency and Durability of HBV siRNAs in the AAV-HBV Mouse Model Publication Number: 831 Session Title: Hepatitis B: Therapeutics: New Agents Presenter: Jin Hong Summary: Aligos’ nonclinical small interfering RNA (siRNA) therapeutic candidates in development for CHB demonstrated improved potency and/or durability in vitro and in vivo when modified with novel siRNA chemistries. Combinations Title: Triple Combination of Anti-Hepatitis B Virus Drugs Demonstrates Synergistic Activity In Vitro Publication Number: 852 Session Title: Hepatitis B: Therapeutics: New Agents Presenter: Hua Tan Summary: Aligos’ siRNA compound in development against hepatitis B virus, ALG-125755, in combination with the company’s ASO, ALG-020572, and STOPS™ molecule, ALG-010133, demonstrated synergistic activity in cell culture with respect to reducing HBsAg when added to various triple-combination groupings with nucleos(t)ide analogs (NA), CAM or interferon. Triple combinations of the siRNA ALG-125755 and STOPS ALG-010133 with the ASO ALG-020572 showed additive activity in reducing HBsAg and demonstrated a dose-dependent response with respect to the ASO. When interferon or STOPS were added to the ASO-siRNA combination, the effect was enhanced, indicating the possibility of lowering doses needed to treat HBV when combined with other HBV therapies. Additionally, when tested in pairwise combinations with a NA or CAM, the compounds demonstrated additive to synergistic interactions on inhibition of HBV DNA. NASH Title: Preclinical Pharmacokinetic Profiling of ALG-055009, a Potent and Selective Thyroid Hormone Receptor Beta Agonist for the Treatment of Nonalcoholic Steatohepatitis, and Prediction of its Human Pharmacokinetics Publication Number: 1932 Session Title: NAFLD and NASH: Therapeutics Presenter: Kusum Gupta Summary: The nonclinical pharmacokinetic properties of ALG-055009 in several animal model species indicate efficacious doses in the clinic are likely to be once daily doses in the sub- to low milligram range and there is likely a with low risk of drug-drug interactions. Title: Development of a Novel Seven-Day Dosing Mouse Efficacy Model to Evaluate Thyroid Hormone Receptor Agonists for the Treatment of NASH Publication Number: 1907 Session Title: NAFLD and NASH: Therapeutics Presenter: Xuan Luong Summary: Authors developed a high-cholesterol diet (HCD) mouse model for efficient in vivo screening of THR-β agonists as potential therapeutic agents in nonalcoholic steatohepatitis (NASH). The model appears to be predictive of patient response at clinically relevant exposures and provides a rapid alternative to the time-consuming standard efficacy models developed through high-fat diet administration. About Aligos Aligos Therapeutics, Inc. is a clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the discovery and development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’s strategy is to harness the deep expertise and decades of drug development experience its team has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered “forward-looking statements,” including, without limitation, statements regarding our belief that that combining multiple modalities that reduce hepatitis B virus S-antigen together with drugs that inhibit viral replication will be the key to achieving enhanced functional cure rates in people living with CHB and that the preclinical pharmacokinetic pro our THR-β agonist drug candidate, ALG-055009, will support once-daily dosing in humans and have a low risk of drug-drug interactions. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “will,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Aligos’s clinical-stage of development, the process of designing and conducting clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Aligos’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Aligos’s capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Aligos in general, see Aligos’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 4, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Aligos undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events. Media Contact Amy Jobe, Ph.D. LifeSci Communications +1 315 879 8192 ajobe@lifescicomms.com Investor Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com

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