Pentazocine Hydrochloride

Company highlights accelerating access and revenue growth for ARBLI™ and confirms REZENOPY™ launch timeline, addressing a combined US annual losartan and naloxone market size of close to $385 million Outlines Q1 2026 outlook and reports significant balance sheet improvement last quarter COMMACK, NY, Feb. 03, 2026 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through the development, commercialization, and distribution of novel specialty products that address unmet market needs, today provided a commercial update on ARBLI™ (losartan potassium) oral suspension, the first and only FDA-approved ready-to-use oral liquid formulation of losartan, alongside key market access achievements, financial strengthening initiatives, and near-term outlook—including reaffirming its plan to commercially launch REZENOPY™, a life-saving opioid overdose emergency treatment, in the second quarter of 2026. Over the past four months, Scienture has executed a series of commercial, payer and patient-focused initiatives designed to materially expand access to ARBLI™ across retail, institutional, and managed care channels within the approximately $241 million in total annual sales and 72 million prescriptions (IQVIA MAT Dec 2025) U.S. losartan market. Key highlights: Secured multiple PBM-led GPO rebate agreements, supporting expanded commercial coverage and formulary placement for ARBLI™Executed multiple Institutional GPO agreements, expanding U.S. access to more than 2,500 healthcare institutions nationwideAchieved formulary inclusion with major national health plans, expanding coverage to over 100 million covered livesEstablished a strategic collaboration with BlinkRx, enhancing patient access, fulfillment, and adherence through a streamlined digital pharmacy and hub service platform “These milestones significantly expand the commercial opportunity for ARBLI™ and represent an important inflection point in its launch trajectory,” commented Narasimhan Mani, President and co-CEO of Scienture. “By securing GPO agreements, expanding formulary inclusion, and partnering with BlinkRx, we are significantly increasing the number of patients and providers who can readily access ARBLI™.” Looking ahead to the first quarter of 2026, Scienture expects: Continued sequential growth in ARBLI™ prescription volumes and product adoptionImproved commercial efficiency, as early launch investments translate into recurring demandFurther expansion of payer and pharmacy engagement, supporting broader patient access across commercial and government sectors “We are encouraged by the steady progress we’ve made with ARBLI™ since launch,” stated Shankar Hariharan, Executive Chairman and co-CEO of Scienture. “The last four months have validated the unmet need for a ready-to-use oral suspension of losartan, and we believe Q1 2026 will reflect the momentum we’ve built across prescriber adoption, distribution, and patient demand.” Scienture reaffirms its plan to commercially launch REZENOPY™, a life-saving opioid overdose emergency treatment in the second quarter of 2026, representing the Company’s second product launch in the US market for naloxone (IQVIA MAT Dec 2025 of $143 million and 9.2 million (eaches) in total annual sales and volume respectively). Management believes REZENOPY™ will leverage Scienture’s expanding commercial infrastructure and access footprint established through ARBLI™. “Our progress with ARBLI™ has laid the groundwork for a scalable, multi-product commercial platform. With REZENOPY™ planned for launch in the first quarter of 2026, we believe Scienture is entering its next phase of growth. Importantly, during Q4 2025, we fundamentally strengthened our balance sheet through a substantial reduction in outstanding debt and a meaningful improvement in our cash resources . As of December 31, 2025, the Company had a cash position of approximately $7.0 million. With an optimized capital structure, we believe we are now well positioned and adequately capitalized to execute our commercial strategy, support the continued growth of ARBLI™, and advance our key operational and pipeline objectives,” concluded Narasimhan Mani, President and co-CEO of Scienture. About ARBLI™ ARBLI™ is a novel proprietary formulation of losartan, a widely prescribed angiotensin receptor blocker (ARB) for hypertension. It is the first and only liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. ARBLI™ is FDA-approved for the treatment of hypertension in patients greater than six years old, for reducing the risk of stroke in patients with hypertension and left ventricular hypertrophy, and for treating diabetic nephropathy in certain patients with type 2 diabetes. By offering a safe, effective, and convenient liquid alternative, ARBLI™ provides a tailored solution for patients who require or prefer a liquid formulation. As an FDA-approved product, ARBLI™ provides consistent quality and dosing accuracy, addressing the risks and inconsistencies often associated with extemporaneously compounded losartan prescriptions. ARBLI™ has two issued patents from the USPTO, which are also listed in the FDA Orangebook. ARBLI™ is the first and only oral liquid formulation of losartan approved by the U.S. FDA. ARBLI™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 24 months from the date of manufacture when stored at room temperature. INDICATION ARBLI™ is an angiotensin II receptor blocker (ARB) indicated for: Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension. IMPORTANT SAFETY INFORMATION Do not take ARBLI™ when pregnant. When pregnancy is detected, discontinue ARBLI™ as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ARBLI™ can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.Do not co-administer ARBLI™ with aliskiren in patients with diabetes. Avoid use of aliskiren with ARBLI™ in patients with renal impairment (GFR <60 mL/min).Do not administer ARBLI™ in patients with severe hepatic impairment. ARBLI™ has not been studied in patients with severe hepatic impairment.The most common adverse reactions are (incidence ≥2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917. Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider. About Hypertension Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg. About REZENOPY™ REZENOPY™ (naloxone HCl) Nasal Spray 10mg, is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. It is intended for immediate administration as emergency therapy in settings where opioids may be present. REZENOPY™ nasal spray is for intranasal use only and is supplied as a carton containing two (2) blister packages each with a single spray device. IMPORTANT SAFETY INFORMATION Administration: REZENOPY™ nasal spray is for intranasal use only. Seek emergency medical care immediately after use. Administer a single spray into one nostril. If the patient does not respond within 2 to 3 minutes or responds and then relapses into respiratory depression, an additional dose may be given into the other nostril with a new device. Do not administer more than 2 sprays per day. Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.Contraindications: REZENOPY™ nasal spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.Warnings and Precautions: Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer additional doses as necessary while awaiting emergency medical assistance.Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid-dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.Risk of Cardiovascular Effects: Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular effects. These events have primarily occurred in patients who had pre-existing cardiovascular disorders or received other drugs that may have similar adverse cardiovascular effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride. Adverse Reactions: The following adverse reactions were observed in a REZENOPY™ nasal spray clinical study: upper abdominal pain, nasopharyngitis, and dysgeusia.Storage and Handling: Store REZENOPY™ nasal spray in the blister and cartons provided. Store between 2°C to 25°C (36°F to 77°F). Excursions permitted up to 40°C (104°F). Do not freeze or expose to excessive heat above 40°C (104°F). Protect from light. REZENOPY™ nasal spray may freeze at cold temperatures. If this happens, the device will not spray. If REZENOPY™ nasal spray is frozen and is needed in an emergency, do NOT wait for it to thaw; get emergency medical help right away. For more detailed information, please refer to the full prescribing information provided by the FDA. About Scienture Holdings, Inc. SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), through its wholly owned subsidiary, Scienture, LLC, is a comprehensive pharmaceutical product company focused on providing enhanced value to patients, physicians and caregivers by offering novel specialty products to satisfy unmet market needs. Scienture, LLC is a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit: www.scientureholdings.com and www.scienture.com. Cautionary Statements Regarding Forward-Looking Statements This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, such as ARBLI™ and REZENOPY™, the success those products may have in the marketplace, and our strategies related to those products. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC. Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law. Contact: SCIENTURE HOLDINGS, INC.20 Austin BlvdCommack, NY 11725Phone: (866) 468-6535Email: IR@Scienture.com