Naloxone hydrochloride

Agreement provides dedicated commercial channel for REZENOPY™ across approximately 2,000 OTP (Opioid Treatment Program) Clinics and other Addiction Treatment Center Networks in the United States According to IQVIA data (MAT July 2026), the U.S. naloxone market generated approximately $140 million in annual sales across 9.8 million units COMMACK, NY, Sept. 22, 2026 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) (“Scienture”), 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 announced that its wholly owned subsidiary, Scienture, LLC, has entered into an exclusive Sales, Marketing and Distribution Agreement with a distribution partner to provide opioid and substance-use disorder treatment centers nationwide with REZENOPY™ (naloxone hydrochloride nasal spray 10 mg/0.11 mL) within the U.S. addiction treatment center market. Under the agreement, REZENOPY™ will be available exclusively through the distribution partner’s established customer network of approximately 2,000 OTP (Opioid Treatment Program) clinics and other Addiction Treatment Centers across the United States, expanding the product’s reach within the substance use disorder treatment market. The agreement complements Scienture’s commercialization strategy and provides access to REZENOPY™ within the defined addiction treatment center field. Scienture will continue to commercialize REZENOPY™ outside this field through multiple concurrent commercial channels, including its existing and future wholesaler agreements, group purchasing organizations (“GPOs”), other distributors and customer relationships. “This agreement represents an important expansion of our commercialization strategy for REZENOPY™ and provides us with a dedicated channel into approximately 2,000 OTP Clinics and addiction treatment centers across the United States,” said Narasimhan Mani, President and Co-Chief Executive Officer of Scienture Holdings. “This strategic collaboration allows us to leverage established experience and relationships within the substance use disorder treatment market, making this relationship complementary to our broader commercialization efforts and provides an additional pathway to expand product availability while we continue building access through our wholesale, GPO, distributor and other institutional channels. As adoption expands across the OTP Clinic and Addiction Treatment Center networks, we believe this relationship has the potential to become a meaningful contributor to REZENOPY™ revenue and support the continued growth of the franchise.” “Expanding access to REZENOPY™ among addiction treatment providers is an important component of our commercial strategy,” Shankar Hariharan, Executive Chairman and Co-Chief Executive Officer of Scienture. “We believe our distribution partner’s established presence in this market can help us efficiently reach treatment centers where naloxone availability is particularly relevant. As adoption develops, we believe this channel has the potential to contribute meaningfully to REZENOPY™’s overall commercial growth alongside our other distribution initiatives.” REZENOPY™ is the highest-dose FDA-approved naloxone hydrochloride nasal spray available in the United States, delivering 10 mg of naloxone hydrochloride in a single-use nasal spray device for the emergency treatment of known or suspected opioid overdose. Built on the proven naloxone molecule and a familiar nasal spray delivery platform, REZENOPY™ is designed to provide an important treatment option for overdoses involving highly potent synthetic opioids. According to IQVIA data (MAT July 2026), the U.S. naloxone market generated approximately $140 million in annual sales across 9.8 million units, highlighting a substantial commercial opportunity for REZENOPY™. As previously disclosed, Scienture, LLC, a wholly-owned subsidiary of Scienture Holdings, Inc., entered into a definitive agreement with Summit Biosciences Inc. (a Kindeva subsidiary) in March 2025, for the exclusive U.S. commercialization rights to REZENOPY™ (naloxone hydrochloride) Nasal Spray 10 mg, which received FDA approval on April 19, 2024. About REZENOPY™ REZENOPY™ (naloxone hydrochloride) 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, the success those products may have in the marketplace, such as REZENOPY™, 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. 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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 Stock Market LLC; 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, as amended, and subsequent reports filed with the Securities and Exchange Commission. 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 11725Email: IR@Scienture.com