Sciatica

精彩内容4月22日，国家药监局官网发布最新药品获批信息，浙江华海药业的美索巴莫注射液和泊沙康唑肠溶片同日获批，截至目前公司今年已累计拿下了8个新品。2024上半年在中国三大终端六大市场，泊沙康唑肠溶片的销售额大涨超过220%，潜力不容小觑。图1：华海药业最新获批的产品来源：国家药监局官网美索巴莫注射液是一款肌肉松弛药，用于治疗关节肌肉扭伤、腰肌劳损、坐骨神经痛等症。米内网数据显示，目前该产品的竞争格局（进口+国产）达18家。图2：美索巴莫注射液的销售情况（单位：万元）来源：米内网格局数据库在中国三大终端六大市场（统计范围见文末），美索巴莫注射液的销售额在2020-2023年保持正增长态势，2023年销售额超过3亿元，2024上半年下滑了7%左右，是肌肉松弛药（化+生）市场TOP5产品。华海药业在2018年拿下了罗库溴铵注射液，成功进军肌肉松弛药（化+生）30亿市场，美索巴莫注射液是公司在该类药物市场第二款获批的产品。泊沙康唑肠溶片是一款全身用抗真菌药，主要用于治疗念珠菌病、隐球菌病、球孢子菌病等。米内网数据显示，目前该产品的竞争格局（进口+国产）达10家。图3：泊沙康唑肠溶片的销售情况（单位：万元）来源：米内网格局数据库在中国三大终端六大市场，泊沙康唑肠溶片的销售额一路飞涨，2022年突破1亿元，2023年涨至2.6亿元以上，2024上半年大涨220%，是全身用抗真菌化药市场TOP6产品。华海药业在2018年拿下了伏立康唑片，成功进军全身用抗真菌化药90亿市场，2023年公司的注射用伏立康唑获批，泊沙康唑肠溶片是公司在该类药物市场第三款获批的产品。表1：华海药业今年以来获批的新产品来源：米内网中国申报进度（MED）数据库今年以来，华海药业硕果丰盈，8个已获批的新品涉及5个大类（7个亚类），其中卡左双多巴缓释片为国产第二家获批。截至目前，华海药业还有1款生物药新药、42个高端仿制药报产在审，公司的产品线将越来越丰富，实力也将逐步提升。资料来源：国家药监局官网、米内网数据库注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。数据统计截至4月23日，如有疏漏，欢迎指正！免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。本文为原创稿件，转载文章或引用数据请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092【分享、点赞、在看】点一点不失联哦

PALO ALTO, Calif., April 11, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, neurodegenerative and cardiometabolic disease, today announced that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-35, to be effective as of 12:01 a.m. Eastern Time on April 15, 2025. Scilex’s common stock will begin trading on a reverse stock split-adjusted basis at the opening of the market on April 15, 2025. Following the reverse stock split, Scilex’s common stock will continue to trade on The Nasdaq Capital Market under the symbol “SCLX” with the new CUSIP number, 80880W 205. The reverse stock split is intended for Scilex to regain compliance with the minimum bid price requirement of $1.00 per share of common stock for continued listing on The Nasdaq Capital Market. The reverse stock split will not change the authorized number of shares of Scilex’s common stock. No fractional shares will be issued in connection with the reverse stock split, and stockholders who would otherwise be entitled to receive a fractional share in connection with the reverse stock split will instead receive a cash payment in lieu thereof equal to such fraction multiplied by the closing sales price of Scilex’s common stock as reported on The Nasdaq Capital Market on April 14, 2025. In addition, the reverse stock split will apply to Scilex’s common stock issuable (or deemed issuable, as applicable) upon the exercise or conversion, as applicable, of certain of Scilex’s outstanding warrants, shares of Series A Preferred Stock, convertible notes and stock options, with proportionate adjustments to be made to the exercise and conversion prices thereof, in each case in accordance with the respective terms of such warrants, shares of Series A Preferred Stock, convertible notes and stock options (and the applicable equity incentive plans). The reverse stock split will reduce the number of issued and outstanding shares of Scilex’s common stock from approximately 243 million to approximately 6.9 million. At Scilex’s special meeting of stockholders held on March 19, 2025, Scilex’s stockholders approved the reverse stock split in connection with Scilex’s common stock and gave Scilex’s board of directors discretionary authority to select a ratio for the reverse stock split ranging from 1-for-14 shares to 1-for-50 shares. Scilex’s board of directors approved the reverse stock split at a ratio of 1-for-35 on April 3, 2025. Continental Stock Transfer & Trust Company is acting as the exchange agent and paying agent for the reverse stock split. Stockholders holding their shares in book-entry form or in brokerage accounts need not take any action in connection with the reverse stock split. Continental Stock Transfer & Trust Company will provide instructions to any stockholders with certificates regarding the process in connection with the exchange of pre-reverse stock split stock certificates for ownership in book-entry form or stock certificates on a post-reverse stock split basis. Stockholders are encouraged to contact their bank, broker or custodian with any procedural questions. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex Holding Company is headquartered in Palo Alto, California. About Semnur Pharmaceuticals, Inc. Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly-owned subsidiary of Scilex, is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding Scilex’s ability to regain or remain in compliance with the continued listing standards of Nasdaq, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts:Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com # # # SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2025 Scilex Holding Company All Rights Reserved.

PALO ALTO, Calif., March 26, 2025 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease, reiterates that it has appealed a lower court decision to the U.S. Court of Appeals for the Federal Circuit in Washington, DC and will continue to vigorously pursue its infringement action on appeal against Aveva Drug Delivery Systems, Inc. (“Aveva”). In May 2022, Scilex received notice that a pharmaceutical maker, Aveva and its former related entities, Apotex Corp. and Apotex Inc. (collectively, the “Apotex Parties”), had submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (“FDA”) and had filed a Paragraph IV notice, alerting both the FDA and Scilex that the proposed product may infringe Scilex’s ZTlido patents that are listed in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations” publication (the FDA’s “Orange Book”). In response, Scilex filed a patent infringement lawsuit against those parties in June 2022, in the U.S. District Court for the Southern District of Florida (the “District Court”), alleging infringement of Scilex’s Orange Book-listed patents covering ZTlido. The Apotex parties were later dismissed from the lawsuit. Following the trial in July 2024, the District Court found that the proposed product did not infringe Scilex’s patents. Scilex has appealed that decision to the U.S. Court of Appeals for the Federal Circuit in Washington, DC. Scilex intends to continue to vigorously pursue its infringement action on appeal. “We remain steadfast in our belief in the strength and validity of our ZTlido intellectual property and that Aveva is infringing on our patents. In light of the Court’s decision, we are pursuing an appellate review at the U.S. Court of Appeals for the Federal Circuit as warranted. We firmly believe we have built a strong portfolio of intellectual property and that the ZTlido franchise is well protected on multiple levels. The infringement suit is ongoing, and we have additional patents that are forthcoming for the follow-on programs,” said Jaisim Shah, President and Chief Executive Officer of Scilex. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on Semnur Pharmaceuticals, Inc., refer to www.semnurpharma.com For more information on ZTlido®, including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com About Scilex Holding Company Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain and, following the formation of its proposed joint venture with IPMC Company, in neurodegenerative and cardiometabolic disease. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and is dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of acute pain and for which Scilex has recently completed a Phase 2 trial in acute low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia. Scilex Holding Company is headquartered in Palo Alto, California. About Semnur Pharmaceuticals, Inc. Semnur Pharmaceuticals, Inc. (“Semnur”), a wholly-owned subsidiary of Scilex, is a clinical late-stage specialty pharmaceutical company focused on the development and commercialization of novel non-opioid pain therapies. Semnur’s product candidate, SP-102 (SEMDEXA™), is the first non-opioid novel gel formulation administered epidurally in development for patients with moderate to severe chronic radicular pain/sciatica. Semnur Pharmaceuticals, Inc. is headquartered in Palo Alto, California Forward-Looking Statements This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the final outcome of the patent infringement lawsuit or the timing thereof, any additional patents that are forthcoming for the follow-on programs, Scilex’s proposed joint venture with IPMC Company and the potential development and commercialization of treatments for obesity, neurodegenerative, cardiometabolic disease. Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: Scilex’s ability to obtain and maintain proprietary protection for its products, technology and know-how and to prevent others from infringing on its proprietary rights, Scilex’s ability to consummate a joint venture or any other transaction with IPMC Company and develop and commercialize treatments for obesity, neurodegenerative, cardiometabolic disease; risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file with the SEC, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law. Contacts: Investors and MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310 Email: investorrelations@scilexholding.com Website: www.scilexholding.com SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company. Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company. ELYXYB® is a registered trademark owned by Scilex Holding Company. All other trademarks are the property of their respective owners. © 2025 Scilex Holding Company All Rights Reserved.