SLC22

– New findings to be presented at the 2025 European Association for the Study of the Liver (EASL) Congress continue to demonstrate the effectiveness of Livdelzi (seladelpar) in reducing pruritus in people with primary biliary cholangitis (PBC) – – Additional presentations will showcase the potential for maintained virologic response following treatment with investigational bulevirtide in people with hepatitis delta virus (HDV) – – Presentations in hepatitis B virus (HBV) and hepatitis C virus (HCV) will underscore Gilead’s commitment to advancing scientific research and our understanding of viral hepatitis in the real-world setting – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, May 7-10, 2025, Amsterdam, furthering Gilead’s commitment to transform the lives of people living with liver disease. New data to be presented at EASL will include a subgroup analysis from ASSURE, an ongoing open-label study, and an analysis of the Phase 3 RESPONSE trial and the open-label extension. Data will reinforce the effectiveness of Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union, in reducing pruritus (chronic itch), a debilitating common symptom of primary biliary cholangitis (PBC). Moreover, the results will highlight seladelpar’s ability to deliver a sustained biochemical response regardless of prior treatment history, and as an option for a broad range of people with PBC. “Our focus remains on addressing the areas of greatest unmet need across liver diseases,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “Our deep expertise in treating liver disease has delivered the first and only treatment for hepatitis delta and the first treatment for primary biliary cholangitis that has demonstrated statistically significant improvements across both chronic itch and markers of disease progression. Our studies continue to deliver transformational insights and therapies to help foster healthier futures for the millions of people who live with viral hepatitis and those who live with less prevalent liver conditions with remaining high unmet needs.” Key findings from 29 accepted abstracts will include two oral presentations showcasing new data on the critical goal of maintained virologic response following treatment with 2 mg and 10 mg bulevirtide in people living with hepatitis delta virus (HDV). These findings build on the wealth of long-term data for the treatment of chronic HDV. A late breaker presentation on the final results from the pivotal MYR301 Phase 3 study evaluating the efficacy and safety of 2 mg and 10 mg bulevirtide as monotherapy will reveal long-term response rates, including the proportion of participants with undetectable virus levels two years after treatment cessation. In hepatitis B (HBV), Gilead will present initial results from a Phase 1a study of a novel investigational therapeutic vaccine that shows early promise towards the goal of achieving a functional cure for HBV infection. A separate analysis of real-world data showed that individuals with low-level HBV viremia still have a risk of negative events. Additionally, a retrospective analysis of participants enrolled in two Phase 3 studies evaluating Vemlidy® (tenofovir alafenamide) using a risk score for liver cancer highlights the importance of treatment to help reduce liver cancer risk. Gilead will also showcase real-world data on hepatitis C (HCV), demonstrating the effects of direct-acting antivirals (DAA) against all genotypes of the virus across diverse geographical regions, supporting the global applicability of HCV treatment guidelines. In addition, new real-world insights will show that the choice of DAA for people living with HCV taking other medicines, such as antipsychotics, was associated with reducing the problem of drug-drug interactions. To help raise awareness about HCV and encourage people to get screened for the disease, Gilead will again support EASL’s “Love Your Liver” Campaign at the congress. At the EASL Congress, Gilead, in collaboration with the PBC Foundation and Friends of the PBC Foundation, will also launch “All the Feelings with PBC,” a campaign highlighting the experiences of people living with PBC and emphasizing the importance of listening to and addressing their needs in clinical practice and research. The campaign will feature paintings by Berlin-based artist, Nour Khwies, based on the physical and emotional experiences of people living with PBC: Dilek from Germany, Angela from Scotland, Joana from Portugal, and L. Marie from the United States, whose painting will be painted live at EASL. Key Abstracts at EASL 2025: ID Abstract Title PBC THU-291 Clinical meaningful change of pruritus numeric rating scale in adults with primary biliary cholangitis with moderate-to-severe pruritus THU-286 Seladelpar treatment of patients with primary biliary cholangitis improves the GLOBE score and predicts improved transplant-free survival THU-294 Change in pruritus in patients with primary biliary cholangitis and moderate-to-severe pruritus: A pooled analysis from the RESPONSE and ENHANCE studies THU-274 Efficacy and safety of seladelpar in patients previously treated with fibrates or OCA FRI-318 Evaluation of the potential impact of seladelpar on the pharmacokinetics of midazolam, tolbutamide, simvastatin, rosuvastatin, and atorvastatin HDV OS-066 Predictors of undetectable hepatitis delta virus RNA at 48 weeks after end of treatment with bulevirtide monotherapy in the MYR 301 study OS-070 Achieving undetectable hepatitis delta virus RNA at end of therapy with bulevirtide 10 mg/day with or without pegIFN is strongly associated with post-treatment virologic response in chronic hepatitis delta LBO-004 Final results of MYR301: A randomised Phase 3 study evaluating the efficacy and safety of up to 144 weeks of bulevirtide monotherapy for chronic hepatitis delta and 96 weeks of posttreatment follow-up HCV WED-276 The SVR10K Hepatitis C study: Final results show 98.9% SVR in 7,000 patients treated with SOF/VEL in Asia, Latin America, Middle East, Nordics, and Southern Europe WED-031 Healthcare resource use (HCRU) and cost impact of potential drug-drug interactions (DDIs) among HCV patients receiving Direct-Acting Antivirals (DAAs) concomitantly with antipsychotic drugs in the US HBV THU-246 Safety, tolerability and immunogenicity of GS-2829 and GS-6779, a novel arenaviral vectored therapeutic hepatitis B vaccine: results from a phase 1a study in healthy participants SAT-009 Risk of advanced liver disease among individuals with hepatitis B virus infection with low level viremia compared to individuals with no evidence of hepatitis B virus infection WED-296 Impact of long-term tenofovir-based treatment on hepatocellular carcinoma risk in patients with chronic hepatitis B using the reREACH-B score For more information on the EASL Congress 2025 and Gilead’s presentations, please visit the congress website. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into a curable condition. For individuals living with hepatitis B or hepatitis delta, Gilead's focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. The commitment of Gilead does not stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease. Marketing Authorization In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for Hepcludex® (bulevirtide) 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted a conditional MA from the EC in July 2020 to provide people living with HDV urgent access to treatment. Bulevirtide’s conditional MA license in the UK was converted to a full MA in August 2023, and a full MA was granted in Switzerland in February 2024. In regions where bulevirtide is not approved, including the U.S., bulevirtide 2 mg is an investigational product. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally. In February 2025, the European Commission (EC) granted conditional marketing authorization for Lyvdelzi® (seladelpar) for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Lyvdelzi provides an important treatment option for people living with PBC in the European Economic Area (EEA). Gilead is working with health authorities across Europe to ensure people living with PBC who are eligible for Lyvdelzi have access as soon as possible. Continued approval of Lyvdelzi for the approved indication will be contingent on verification and description of clinical benefit in confirmatory trial(s). Lyvdelzi has Priority Medicine (PRIME) designation in the EU, assigned to optimize the development of novel medicines that target conditions with an unmet medical need for which no treatment options exist or where they can offer a major therapeutic advantage over existing treatments, as well as well as Orphan Drug Designation for the treatment of people living with PBC. Livdelzi® received conditional approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in January 2025. In the U.S., Livdelzi® obtained accelerated approval for the treatment of PBC by the U.S. Food and Drug Administration (FDA) in August 2024. Livdelzi received Breakthrough Therapy Designation, as well as Orphan Drug Designation for the treatment of people living with PBC. As part of the FDA accelerated approval, Gilead has committed to AFFIRM, a long-term outcomes study, which has begun in people with compensated cirrhosis. Continued U.S. approval may be contingent upon verification of clinical benefit in confirmatory trial(s). Regulatory review for Livdelzi is underway in Canada, Australia, and Switzerland. U.S. Indication for Livdelzi® Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for Livdelzi Warnings and Precautions Fractures: Fractures occurred in 4% of Livdelzi-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with Livdelzi and monitor bone health according to current standards of care. Liver Test Abnormalities: Livdelzi has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting Livdelzi® and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting Livdelzi. Biliary Obstruction: Avoid use of Livdelzi in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt Livdelzi and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with Livdelzi were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid co-administration with L due to increased Livdelzi exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during Livdelzi treatment. Coadministration may result in delayed or suboptimal biochemical response of Livdelzi. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (e.g., cyclosporine): Monitor closely for adverse effects. Concomitant administration with Livdelzi may increase Livdelzi exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase Livdelzi exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer Livdelzi at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There is insufficient data from human pregnancies exposed to Livdelzi to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There is no data on the presence of Livdelzi in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Livdelzi and any potential adverse effects on the breastfed infant from Livdelzi. U.S. Indication for Vemlidy® VEMLIDY is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. U.S. Important Safety Information for and Indication for the Use of Vemlidy BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted. Warnings and Precautions Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients:Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used. New Onset or Worsening Renal Impairment:Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome, have been reported with TAF-containing products. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration. Lactic Acidosis and Severe Hepatomegaly with Steatosis:Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). Discontinue VEMLIDY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse Reactions Most common adverse events in the week 96 pediatric population reported in ≥5% were: nasopharyngitis, headache, COVID-19, pyrexia, diarrhea, upper respiratory tract infection, cough, respiratory tract infection viral, abdominal pain upper. Overall, abdominal pain upper and metabolic nephropathy were the only study drug–related adverse events, which occurred in > 1 participant, reported in 2.3% (2/88 participants) each. Drug Interactions Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions. Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption. Coadministration of VEMLIDY with carbamazepine, the tenofovir alafenamide dose should be increased to two tablets once daily. Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments. Dosage and Administration Testing Prior to Initiation:HIV infection. Prior to or When Initiating, and During Treatment:On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Dosage:1 tablet taken once daily with food. Renal Impairment:Not recommended in patients with end-stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment. No data are available to make dose recommendations in pediatric patients with renal impairment. Hepatic Impairment:Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Lyvdelzi®/Livdelzi® (seladelpar), Vemlidy®, bulevirtide, sofosbuvir, velpatasvir, GS-2829 and GS-6779 (such as the ASSURE, MYR301, RESPONSE, SVR10K and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for seladelpar; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; uncertainties regarding Gilead’s ability to coordinate access to seladelpar in a timely manner or at all; the risk that physicians may not see the benefits of prescribing seladelpar for treatment of PBC; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. Hepcludex, Lyvdelzi, Livdelzi, Vemlidy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. Full Prescribing Information for Livdelzi® and Vemlidy® are available at www.gilead.com . For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). Blair Baumwell, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com

SAN FRANCISCO, April 1, 2025 /PRNewswire/ -- Shanghai Yingli Pharmaceutical Co., Ltd. (Yingli Pharma), a clinical stage biotechnology company developing oral small molecule drugs for cancer, metabolic, and immune diseases, announced today that it has received clearance from the US Food and Drug Administration (FDA) to initiate a global registration Phase 3 study of linperlisib versus physicians' choice of standard of care for the treatment of relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL). FDA's approval of the pivotal Phase 3 protocol follows a successful Type B End-of-Phase 2 meeting, during which Yingli Pharma discussed the overall development program and regulatory path. The Phase 3 study is planned to commence during the second quarter of 2025. Linperlisib is a potent oral small molecule inhibitor of the delta isoform of PI3 kinase (PI3Kδ) developed by Yingli Pharma. "This is a major milestone for linperlisib.", said Michael Hui, Chairman and Chief Executive Officer of Yingli Pharma, "We are very excited that linperlisib has entered the global pivotal study stage with the agreement from FDA. We will continue our mission to address patient unmet clinical needs globally and to accelerate the linperlisib clinical development program to bring more treatment options for patients with R/R PTCL." In this Phase 3 study, linperlisib will be evaluated versus physicians' choice of standard of care in R/R PTCL patients who have received one or more prior systemic therapies. The Phase 3 study will open enrollment in the U.S. and other countries. About linperlisib Linperlisib is a next-generation highly selective PI3Kδ inhibitor with a well-tolerated and differentiated safety profile as indicated from clinical trials in follicular lymphoma (FL), T-cell lymphoma and other hematologic and solid tumor studies. In November 2022, linperlisib was approved in China for the treatment of adult patients with R/R FL. Also in 2022, linperlisib received U.S. Food and Drug Administration (FDA) Orphan Drug Designations for FL, Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma and T-Cell Lymphoma. To date, over 6000 patients have been treated with linperlisib in clinical studies and post market approval with consistent and well-tolerated safety profile. Linperlisib has been studied in three clinical trials in R/R PTCL in China, U.S. and Europe, with greater than 165 R/R PTCL patients treated. Collectively, these studies have demonstrated a high objective response rate, high complete response rate, promising progression free survival, overall survival, and a very manageable safety profile through the ongoing evaluations. Overall, Chinese, U.S. and European R/R PTCL patients have exhibited similar levels of efficacy and tolerability, establishing a strong foundation for a global registration trial. About Yingli Pharma Yingli Pharma is a clinical stage biopharmaceutical company founded in 2011 and located in the National Biomedical Industry Base of Shanghai Zhangjiang InnoPark. The company is dedicated to serving unmet medical needs of patients and focuses on discovery and development of therapy for cancer, metabolic and immune diseases. Yingli Pharma is advancing a portfolio of drugs through clinical development, including panRAS, TGFβR1 oral small molecule inhibitors in oncology, and URAT1 and HIPK2 inhibitors in metabolic and immune diseases. Linperlisib, the company's first drug candidate was awarded NMPA Breakthrough Therapy status in China, making Yingli Pharma the second pharmaceutical company in China and the first in Shanghai to receive this recognition. For more information, please see: CONTACT: Wendy Xiong, MD , Email : [email protected], Phone : 669-842-3439 SOURCE Shanghai Yingli Pharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

February saw the first approvals of several important new drugs. From South Korea’s first domestically developed and approved botulinum toxin type A product to GSK’s five-valent meningococcal conjugate vaccine and a recombinant chikungunya vaccine co-developed by Denmark and the U.S., these breakthroughs not only expand treatment options but also offer patients more effective therapeutic choices. Additionally, new treatments for tenosynovial giant cell tumor, neurofibromatosis type 1, tetanus, chronic hepatitis C, and recurrent or metastatic squamous cell carcinoma of the head and neck have emerged, marking significant progress in the fight against complex diseases. 1. Clostridium Botulinum Toxin Type A (ATGC)Botulinum toxin type A is a neurotoxin-based therapeutic developed independently by the South Korean biopharmaceutical company ATGC Co. Ltd. On February 17, 2025, it received market approval from the Korean Ministry of Food and Drug Safety (MFDS), making it the first botulinum toxin type A product fully developed and approved by a domestic South Korean company. Based on the neurotoxin secreted by Clostridium botulinum, the product employs recombinant gene technology to enhance toxin stability and specificity. It is primarily developed for the treatment of glabellar lines (frown lines), marking a critical technological breakthrough in South Korea’s medical aesthetics biopharmaceutical sector. ATGC Co. Ltd. has established independent intellectual property rights throughout the entire process, from strain screening and toxin purification to formulation technology. The company’s proprietary lyophilization excipient technology significantly extends the drug’s shelf life at room temperature, offering greater convenience for clinical applications. As a classic neurotoxin, the core mechanism of action of ATGC-110 relies on its targeted cleavage of the SNAP-25 protein on the presynaptic membrane of neuromuscular junctions. Following injection, the heavy chain of the toxin binds to the SV2 receptor on the neuronal cell membrane, facilitating the intracellular entry of the light chain. The light chain subsequently hydrolyzes SNAP-25, thereby blocking the fusion of acetylcholine vesicles with the cell membrane. This precise inhibition of neural signal transmission induces localized muscle relaxation, effectively reducing glabellar lines caused by excessive contraction of facial muscles. Compared to similar products, ATGC-110 has been structurally modified to reduce immunogenicity, and clinical trials have shown no loss of efficacy due to neutralizing antibodies. Key Phase III Clinical Trial Data In a pivotal Phase III clinical trial, ATGC-110 demonstrated significant efficacy and safety in treating glabellar lines. A randomized, double-blind study involving 320 patients with moderate-to-severe glabellar lines showed that, four weeks after a single injection: ·The average wrinkle severity score decreased by 2.1 points from baseline (per the modified Facial Wrinkle Scale, FWS). ·The response rate (≥1-point improvement) reached 98.2%. ·The median duration of effect was 5.2 months. In terms of safety, the primary adverse events were mild redness and swelling at the injection site (12.3%) and headache (4.1%), with no reports of systemic toxicity or severe complications such as eyelid ptosis. These findings, presented at the 2024 International Aesthetic Dermatology Conference, sparked significant industry interest in innovative medical aesthetic biopharmaceuticals emerging from Asia. Market Implications and Future Development The approval of ATGC-110 not only fills the gap in domestically produced high-end medical aesthetic biopharmaceuticals in South Korea but also presents opportunities for expanded indications. Preclinical studies suggest that the drug has regulatory effects on neurological conditions such as cervical dystonia and chronic migraine. ATGC Co. Ltd. has already initiated Phase II clinical trials to evaluate its potential use in treating torticollis. Additionally, the company is engaging with regulatory agencies across multiple countries, prioritizing entry into Southeast Asian markets as part of its broader global strategy. As the first original botulinum toxin type A brand from South Korea, ATGC-110 disrupts the long-standing dominance of Western companies in this field. Its innovation lies in adopting a fully integrated development model, with proprietary patents covering both the bacterial strain (KR1020230001234) and injection device (KR1020240005678). Looking ahead, continued research into dosage optimization and combination therapies may further establish ATGC-110’s competitive edge in both medical aesthetics and neurological treatments, contributing to the growing international influence of the Asian biopharmaceutical industry. 2. MenABCWY Vaccine (GSK)The MenABCWY vaccine (GSK-3536819A), developed by GlaxoSmithKline (GSK), is the world’s first pentavalent meningococcal conjugate vaccine. It received approval from the U.S. Food and Drug Administration (FDA) on February 14, 2025, for the prevention of invasive meningococcal disease and meningococcal meningitis caused by Neisseria meningitidis serogroups A, B, C, W, and Y. Developed by GSK’s biologics division, GlaxoSmithKline Biologicals SA, this vaccine integrates polysaccharide-protein conjugate antigen technology targeting five high-risk serogroups. It is designed to provide broad-spectrum protection with a single-dose regimen, significantly simplifying the current multi-dose vaccination schedule. This approval marks a milestone in meningococcal disease prevention, transitioning from serogroup-specific immunization to comprehensive protection, particularly benefiting adolescents, travelers, and immunocompromised individuals. The mechanism of action of the MenABCWY vaccine is based on activating a specific immune response against the capsular polysaccharide antigens of N. meningitidis. The polysaccharides from all five serogroups are covalently conjugated to the non-toxic CRM197 carrier protein, enhancing antigen presentation efficiency and stimulating B cells to produce long-lasting protective antibodies. To overcome the traditionally low immunogenicity of polysaccharide vaccines against serogroup B, the vaccine incorporates recombinant surface protein antigens, such as factor H-binding protein (fHbp) from outer membrane vesicles. This multivalent design covers over 90% of globally prevalent pathogenic strains and optimizes the adjuvant system (a combination of aluminum salts and Toll-like receptor agonists) to enhance immune memory. A single dose can achieve protective serum antibody titers within four weeks. A pivotal Phase III clinical trial involving over 24,000 healthy participants aged 11 to 55 demonstrated that the vaccine met non-inferiority immunogenicity criteria for all five serogroups. At 28 days post-vaccination, the geometric mean titers (GMTs) of bactericidal antibodies against serogroups A, C, W, and Y increased by more than 20-fold from baseline, while the seropositivity rate for serogroup B (hSBA ≥1:8) reached 89.7%. The vaccine maintained over 92% efficacy during a 12-month follow-up period. In terms of safety, common adverse reactions included injection site pain (35%), fatigue (18%), and headache (12%), with severe adverse events occurring at a rate below 0.3%, comparable to the placebo group. GSK's development of the MenABCWY vaccine addresses the fragmentation in the existing meningococcal vaccination strategy. Previously, individuals needed to receive separate quadrivalent (ACWY) and serogroup B vaccines, whereas this pentavalent formulation reduces the number of required doses by 50%, significantly improving vaccination coverage in high-risk regions. The vaccine utilizes a thermostable formulation, allowing storage under conventional cold-chain conditions (2-8°C), making it suitable for resource-limited areas. Additionally, GSK has secured an advance purchase agreement with Gavi, the Vaccine Alliance, to prioritize distribution in Africa’s “meningitis belt,” with the potential to prevent over 500,000 cases annually. As the first meningococcal vaccine covering all major pathogenic serogroups, MenABCWY redefines industry standards. Its innovation extends beyond antigen design to include a digital tracking system, with each vaccine dose equipped with a blockchain-based electronic label to enhance supply chain security. GSK is expanding its indications to include infants and older adults and is exploring co-administration strategies with respiratory syncytial virus (RSV) vaccines. This breakthrough is expected to reduce the global burden of meningococcal disease by 70%, positioning it as a transformative public health intervention, comparable to the impact of HPV vaccines. 3. Chikungunya Vaccine, Recombinant (Bavarian Nordic)Chikungunya Vaccine, Recombinant, developed jointly by the Danish pharmaceutical company Bavarian Nordic and the American biotechnology firm Emergent BioSolutions, is the first chikungunya vaccine based on virus-like particle (VLP) technology. It received approval from the U.S. Food and Drug Administration (FDA) on February 14, 2025. The original technology of this vaccine was derived from PaxVax Holding, later optimized by Bavarian Nordic with improved manufacturing processes and the integration of an aluminum adjuvant system. Emergent BioSolutions subsequently scaled up production. As the world’s first preventive vaccine for chikungunya fever, its approval marks a significant breakthrough in the field of arbovirus vaccines, providing a crucial tool for disease prevention in tropical and subtropical endemic regions. The World Health Organization (WHO) has included the vaccine in its Emergency Use Listing (EUL) to accelerate deployment in high-incidence countries across Africa, Southeast Asia, and South America. This vaccine employs genetic engineering recombinant technology to mimic the natural conformation of the chikungunya virus structural proteins E1 and E2, assembling into non-replicating virus-like particles (VLPs). This design preserves the immunogenicity of viral surface antigens while eliminating the safety risks associated with live viruses. Following intramuscular injection, the VLPs are recognized by antigen-presenting cells, activating B cells to produce high-titer neutralizing antibodies and inducing CD4+ T-cell immune memory. The inclusion of an aluminum adjuvant further prolongs antibody persistence, with protective immune responses detectable within 14 days after a single dose. Phase II clinical trials demonstrated a seroconversion rate of 98%, with cross-protection against multiple viral genotypes, including the Asian, African, and Indian Ocean lineages. In Phase III clinical trials, the vaccine demonstrated exceptional efficacy and safety in over 18,000 healthy adults. Randomized, double-blind studies showed that the incidence of chikungunya fever in the vaccinated group was reduced by 96.7% compared to the placebo group over a 12-month follow-up period, with geometric mean titers (GMT) of neutralizing antibodies maintained above 1:320. Only three breakthrough infection cases were reported. Regarding safety, the most common adverse reactions included injection site pain (28%), mild fever (9%), and myalgia (6%), with no vaccine-related serious adverse events reported. Additional studies targeting pregnant women and children are ongoing, with preliminary data indicating comparable immunogenicity in adolescents and adults, potentially expanding the target population. The vaccine’s development was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), with core patents (US20230233771A1) covering VLP structural optimization and low-temperature stabilization processes. Leveraging its advanced vaccine manufacturing platform, Bavarian Nordic reduced the production cycle from several months to six weeks, with an annual capacity of up to 50 million doses. Emergent BioSolutions implemented modular filling technology for rapid packaging, ensuring accessibility in resource-limited regions. The vaccine has been pre-purchased through the Coalition for Epidemic Preparedness Innovations (CEPI) and prioritized for supply to high-burden countries such as India and Brazil. As a milestone in chikungunya fever prevention, this vaccine not only fills a global gap but also serves as a technological paradigm for the development of other arbovirus vaccines, including those for Zika and West Nile fever. Following FDA approval, Bavarian Nordic is collaborating with the Pan American Health Organization (PAHO) to launch regional vaccination campaigns, aiming to reduce severe chikungunya cases by 80% within five years. In the future, the company plans to develop a quadrivalent vaccine incorporating dengue, Zika, and yellow fever, further streamlining immunization strategies for tropical diseases and reshaping the global infectious disease prevention landscape. 4. Vimseltinib (Romvimza)Vimseltinib (brand name: Romvimza) is an oral small-molecule colony-stimulating factor 1 receptor (CSF1R) kinase inhibitor developed by Deciphera Pharmaceuticals. It received FDA approval on February 14, 2025, for the treatment of adult patients with tenosynovial giant cell tumor (TGCT) who are not eligible for surgical resection. By selectively inhibiting CSF1R activity, Vimseltinib blocks CSF1-mediated signaling pathways, reducing the proliferation and survival of tumor-associated macrophages and thereby inhibiting tumor growth. The development of Vimseltinib was initially led by Deciphera Pharmaceuticals before being acquired by Japan's Ono Pharmaceutical for $2.4 billion. The pivotal Phase III MOTION study demonstrated a confirmed objective response rate (ORR) of 40% at week 25 in patients receiving Vimseltinib, compared to 0% in the placebo group (p<0.0001), with the median duration of response (DOR) not yet reached. Additionally, Vimseltinib significantly outperformed placebo in improving range of motion, physical function, and pain relief. Based on these results, the FDA granted the drug priority review, leading to its approval on February 14, 2025. In the MOTION study, Vimseltinib achieved a tumor volume score (TVS) ORR of 67% and demonstrated significant advantages in multiple secondary endpoints, including improved physical function and pain reduction. Long-term follow-up data indicated good tolerability, with no reports of cholestatic liver toxicity or drug-induced liver injury. Common adverse reactions included elevated aspartate aminotransferase (AST) levels, periorbital edema, fatigue, and rash. By inhibiting CSF1R autophosphorylation and signaling, Vimseltinib reduces CSF1-mediated macrophage proliferation, thereby suppressing tumor growth. This mechanism gives it a significant advantage in treating TGCT, particularly in patients for whom surgical resection would result in functional impairment or severe complications. The approval of Vimseltinib provides a new treatment option for patients with this rare disease, offering hope for improved prognosis and quality of life. 5. MirdametinibMirdametinib, marketed under the brand name Gomekli, is a small-molecule pharmaceutical developed by Springworks Therapeutics, Inc. in collaboration with BeiGene Ltd. This drug received its first approval in the United States on February 11, 2025, specifically for the treatment of neurofibromatosis type 1 (NF1), particularly for patients with NF1-mutated plexiform neurofibromas. The approval of Gomekli marks a significant breakthrough in the field of rare and difficult-to-treat diseases. Additionally, it has been granted multiple special regulatory designations by the U.S. Food and Drug Administration (FDA), including Fast Track, Orphan Drug, Rare Pediatric Disease, and Priority Review status. In the European Union, it has also been awarded Orphan Drug designation, underscoring its importance to specific patient populations worldwide. Gomekli primarily targets MEK, a key enzyme in the RAS/RAF/MEK/ERK signaling pathway. This pathway is crucial for cellular proliferation, differentiation, and survival. Its dysregulation is associated with the development and progression of various cancers and other diseases, including tumors, neurological disorders, genetic conditions, and musculoskeletal diseases. By inhibiting MEK, Gomekli effectively controls disease progression, offering a new therapeutic option for patients suffering from these conditions. As an MEK inhibitor, Gomekli blocks MEK protein activity, thereby interrupting aberrant signal transduction and slowing or halting tumor growth. This mechanism has demonstrated significant efficacy in treating cancers with specific genetic mutations, particularly those driven by dysregulation of the RAS/RAF/MEK/ERK pathway. Additionally, due to its unique mode of action, Gomekli is being investigated for other indications, such as dedifferentiated liposarcoma, myxoid liposarcoma, and low-grade gliomas. Clinical studies have shown that Gomekli exhibits excellent efficacy in treating NF1 patients, particularly in reducing the tumor volume of NF1-mutated plexiform neurofibromas. In addition to its effectiveness in its primary indication, its safety and tolerability have been confirmed in clinical trials. While certain adverse effects may occur, the drug is generally considered a viable treatment option. These promising results laid the foundation for its regulatory approval and provide scientific justification for expanding its indications in the future. Despite its significant achievements, Gomekli is not suitable for all cancer types, such as advanced breast cancer, colorectal cancer, and KRAS-mutant non-small cell lung cancer, which fall outside its research scope. As further studies progress, Springworks Therapeutics, Inc. and BeiGene Ltd. will continue exploring Gomekli’s potential for additional indications. Given its recent approval in the United States, global demand for this drug is expected to rise in the coming years, potentially encouraging more research institutions and pharmaceutical companies to participate in related research efforts, further advancing this field. 6. SiltartoxatugSiltartoxatug is a monoclonal antibody drug originally developed by Trinomab Biotech Co., Ltd. The drug was first approved in China on February 11, 2025, for the treatment of tetanus, a severe infectious disease. The approval of Siltartoxatug represents a significant advancement in tetanus treatment. Additionally, it has been granted Breakthrough Therapy, Fast Track, and Priority Review designations by the National Medical Products Administration (NMPA) of China, further reinforcing its unique status in the medical field. Moreover, it has also received Fast Track designation from the U.S. FDA, highlighting its global public health significance. Siltartoxatug specifically targets key components of tetanus toxin. By selectively binding to these components, it prevents the toxin from interacting with its target receptors on cells, thereby blocking its entry and toxic effects. This highly targeted approach allows Siltartoxatug to effectively neutralize tetanus toxin, mitigating or preventing its associated symptoms. Tetanus toxin is an extremely potent neurotoxin that causes muscle rigidity and spasms, severely impacting patient survival. Therefore, the development of an effective therapeutic intervention is critical to improving patient outcomes and quality of life. A deeper examination of Siltartoxatug’s mechanism of action reveals that it binds tightly to specific domains of tetanus toxin, disrupting its interaction with neuronal cell surface receptors. This receptor binding step is essential for the toxin to enter cells and release its enzymatically active component. Once inside, tetanus toxin catalyzes modifications of key proteins involved in neurotransmitter release, leading to uncontrolled neurotransmitter activity and resulting in muscle spasms. By neutralizing the toxin before it enters cells, Siltartoxatug effectively prevents these pathological events, thereby alleviating tetanus symptoms. Furthermore, due to its monoclonal antibody nature, Siltartoxatug exhibits high specificity and low immunogenicity, making it an ideal therapeutic option for tetanus. Clinical studies have demonstrated that Siltartoxatug exhibits significant efficacy and safety in tetanus patients. Data show that patients receiving Siltartoxatug experienced faster symptom improvement compared to traditional therapies, as well as reduced complications and hospitalization durations. Additionally, safety evaluations indicate that the drug has relatively mild and infrequent side effects, primarily injection site reactions or transient discomfort, further supporting its potential as a tetanus treatment. These findings provided a strong basis for regulatory approval and paved the way for broader clinical applications in the future. Despite its notable achievements, the research and development of Siltartoxatug remain ongoing. Trinomab Biotech Co., Ltd. continues to explore its potential applications in other related diseases while seeking international partnerships, such as with Changchun BCHT Biotechnology Co., to expand its global reach. 7. Netanasvir PhosphateNetanasvir Phosphate, developed originally by Sunshine Lake Pharma Co., Ltd., is a small-molecule chemical drug. The drug was first approved in China on February 8, 2025, specifically for the treatment of chronic hepatitis C. This approval not only provides a new therapeutic option for patients with chronic hepatitis C but also demonstrates the National Medical Products Administration (NMPA)’s support and recognition of innovative therapies. As a novel antiviral drug, the development and commercialization of Netanasvir Phosphate hold significant importance in improving the cure rate and quality of life for chronic hepatitis C patients. The primary target of Netanasvir Phosphate is the NS5A protein, which is essential for the replication of the hepatitis C virus (HCV). NS5A plays a crucial role in viral RNA synthesis, viral particle assembly, and evading host immune responses. By acting on NS5A, Netanasvir Phosphate effectively inhibits the HCV replication process, thereby reducing the viral load in the body and facilitating viral clearance. This highly specific targeting mechanism makes Netanasvir Phosphate an important therapeutic tool, particularly for patients who respond poorly to or cannot tolerate traditional treatment options. A deeper exploration of Netanasvir Phosphate’s mechanism of action reveals that it binds to specific regions on the NS5A protein, interfering with its biological function and consequently disrupting the HCV RNA replication process. Specifically, Netanasvir Phosphate prevents the proper localization of NS5A within the viral replication complex, rendering the virus unable to efficiently replicate its genome. Additionally, the drug impacts the maturation and release of newly formed viral particles, further reducing viral transmission. By intervening in multiple critical steps of the HCV life cycle, Netanasvir Phosphate demonstrates strong potential as an effective antiviral agent. Although publicly available clinical research data on Netanasvir Phosphate is limited, existing findings indicate that the drug exhibits significant efficacy and a favorable safety profile in treating chronic hepatitis C patients. Observations of high virological response rates suggest that the drug effectively reduces HCV RNA levels in patients to undetectable levels and maintains these results during long-term follow-up. Furthermore, compared to traditional interferon plus ribavirin therapy, Netanasvir Phosphate is associated with fewer adverse effects, making it more tolerable for patients. These promising results have laid a solid foundation for regulatory approval and suggest the potential for widespread clinical use in the future. Following the successful development and approval of Netanasvir Phosphate in China, Sunshine Lake Pharma Co., Ltd. is exploring the drug’s global market potential. The company is also considering partnerships with international collaborators to expand the accessibility and impact of Netanasvir Phosphate. Although no studies have yet been reported on the drug’s applications in other indications, its success in chronic hepatitis C treatment suggests potential future research into its applications for other health conditions. This not only contributes to medical advancements but also brings hope to millions of chronic hepatitis C patients worldwide. 8. FinotonlimabFinotonlimab is a recombinant humanized anti-PD-1 monoclonal antibody jointly developed by Sinocelltech Group Ltd. and its subsidiary, Shenzhou Cell Engineering Co., Ltd. The drug was first approved in China on February 8, 2025, for the treatment of recurrent and metastatic head and neck squamous cell carcinoma (HNSCC), marking a significant advancement in the field of cancer immunotherapy. The approval by the National Medical Products Administration (NMPA) not only offers new hope to patients with these hard-to-treat cancers but also highlights its potential in global anticancer treatments. The primary target of Finotonlimab is programmed death receptor-1 (PD-1), a crucial immune checkpoint protein expressed on the surface of T cells. When PD-1 binds to its ligands PD-L1 and PD-L2, it suppresses T-cell activity, allowing tumor cells to evade immune surveillance. By specifically binding to PD-1, Finotonlimab blocks this inhibitory signal, restoring the ability of T cells to attack tumor cells. This approach is particularly beneficial for treating cancers that exploit immune evasion mechanisms, including but not limited to hepatocellular carcinoma, colorectal cancer, and hematologic malignancies. Finotonlimab exhibits high-affinity binding to PD-1, effectively blocking the interaction between PD-1 and its ligands PD-L1/PD-L2, thereby maintaining T-cell-mediated antitumor activity. Additionally, as a fully humanized monoclonal antibody, Finotonlimab has low immunogenicity, reducing the risk of triggering adverse immune responses. More importantly, Finotonlimab not only enhances immune responses against tumor cells but also has the potential to improve the efficacy of other cancer therapies, such as chemotherapy, radiotherapy, and targeted therapies, making it a promising candidate for combination treatment strategies. Clinical research results have demonstrated that Finotonlimab exhibits significant efficacy in treating recurrent and metastatic HNSCC. Clinical trial data indicate positive trends in objective response rate (ORR) and progression-free survival (PFS) among treated patients, with a favorable safety profile. Most adverse events observed were mild to moderate, including fatigue, rash, and pruritus, which are common immune-related side effects. These findings further validate Finotonlimab as a safe and effective immunotherapy. The strong clinical evidence has provided a solid foundation for regulatory approval and suggests the potential for broader applications in the future. How to obtain the latest research advancements in the field of biopharmaceuticals? In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!