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点击蓝字 关注我们 农历十月十四 December.3星期三 Daily News 源创 | 药闻资讯 NEWS 天气 1℃~8℃ 01 生活提示 体感温度 4℃ 体感舒适 紫外线指数 4弱 湿度 28% 北风＜3级 穿衣 宜穿大衣 02 化药CDE最新受理 情况与批件送达信息 03 中药CDE最新受理 情况及批件送达信息 04 生物药CDE最新受理 情况与批件送达信息 05 药闻资讯 1.关于将Vorasidenib纳入“儿童抗肿瘤药物研发鼓励试点计划（星光计划）”试点项目的通知。 链接： https://www.cde.org.cn/main/news/viewInfoCommon/e6c468cbe43c54601d2c197136b5f386 2.关于公开征求《药物研发及申报临床常见问题技术指导原则（征求意见稿）》意见的通知。 链接： https://www.cde.org.cn/main/news/viewInfoCommon/17b37729742949c6198d8faa4a018b85 06 热点聚焦 1 .国家卫健委2日发布公报，2024年全国医疗卫生机构总诊疗人次101.5亿，比上年增加6亿人次。 2 .香港特区政府2日下午就大埔宏福苑火灾召开记者会介绍，截至当天下午4点，火灾已造成156人遇难，仍有约30人失联。 3 .香港特区政府表示，将确保大埔宏福苑灾民有免费住屋，直至他们重建家园。 07 每日充电站 图片来自网络 星光不问赶路人，时光不负有心人。将简单的事做到极致，便是不简单；将平凡的事做到极致，便能成就非凡。你只管努力，时间自会给你想要的答案。 重磅通知 我司现有雷贝拉唑钠肠溶片、丙戊酸钠原料药、沙库巴曲缬沙坦钠原料药项目、氯雷他定糖浆项目研发进程取得重大进展，项目进展情况如下： 1.雷贝拉唑钠肠溶片项目     已完成中试放大研究，产品工艺重现性好，质量稳定可控，预计BE通过率很高，目前待开展临床研究，全套药学研究资料可转让。  2.丙戊酸钠原料药研发项目    已完成小试工艺放大研究，规模400克/批，常规反应条件，工艺适合放大生产，总收率65%，工艺具备物料成本优势，待中试放大研究，中间体1的制备方法申请发明1篇，国家知识产权局已受理，正在实质审查中。 3.沙库巴曲缬沙坦钠原料药项目 已完成小试工艺放大研究，规模400g/批，常规反应条件，工艺适合放大生产，总收率70%，具备物料成本优势，待中试放大研究，其杂质制备方法申请发明1篇，国家知识产权局已受理，正在实质审查中。 3.氯雷他定糖浆项目     已完成工艺验证并完成长期12个月的稳定性考察，申报资料已提交CDE并已受理，正在实质审查中。 欢迎意向客户垂询 联 系 人：张女士 联系电话：+86-13812760254 邮      箱：zhangjie@youtron.cn 企业简介： 苏州源创药物研究有限公司成立于 2017 年，是苏州园区科技局授予挂牌的“苏州工业园区药物评价中心”，为一站式药品研发平台，隶属于苏州工业园区生物医药产业创新中心系列平台体系。公司以小分子化学原料药及中间体、仿制药制剂为主要研究方向。公司已荣获“江苏省民营科技企业”、“苏州工业园区企业上市苗圃工程”、“高新技术企业”等殊荣。 以股东瑞星集团为强力依托，瑞星集团为集高端化工、生物医药、粮食加工三大主体板块和技术研发、国际贸易为一体的大型现代化企业集团，集团拥有职工5000余人，总资产200亿元，年营业收入200亿元，荣获“中国民营企业500强”、“中国制造业企业500强”、国家高新技术企业的等称号，苏州源创药物作为瑞星集团的医药研发中心，以旗下山东普瑞曼药业作为制剂生产基地，山东鲁瑞药业为原料药生产基地，已与多家知名药企、研发单位、持有人（MAH方）合作，以高效的技术转移服务、专业的商业化生产能力，打造合作共赢的CMO合作平台。 苏州源创药物长期致力于创新药和仿制药及其高附加值医药中间体以及药物杂质的开发和生产服务，平台将QbD的管理理念应用到创新药和仿制药研发的每个阶段管理中。涵盖药物研发全生命周期管理，提供制剂研发的一站式整体解决服务，包括药学研究、委托生产、生物等效性研究、申报注册、MAH持证管理、上市后技术支持等。 END

Correction: In the press release published on November 28, 2025, the total financing amount was incorrectly stated as up to SEK 650 million upon full exercise of warrants and convertibles. The correct total amount is up to SEK 665 million. The full corrected press release is provided below. No other information has been changed. THIS PRESS RELEASE MAY NOT BE DISTRIBUTED, RELEASED, OR PUBLISHED, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, BELARUS, CANADA, HONG KONG, JAPAN, NEW ZEELAND, RUSSIA, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, OR ANY OTHER JURISDICTION IN WHICH SUCH ACTIONS, WHOLLY OR IN PART, WOULD BE UNLAWFUL OR DEMAND ADDITIONAL REGISTRATION OR OTHER MEASURES. PLEASE REFER TO “IMPORTANT INFORMATION” IN THE END OF THIS PRESS RELEASE. Cereno Scientific (Nasdaq First North: CRNO B) (the “Company”), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, announced today that the Company has entered into a loan financing agreement (the “Financing Agreement”) securing loan financing of up to SEK 350 million, and that the Board of Directors has resolved, by virtue of the authorization from the Annual General Meeting, on a directed issue of new B-shares of SEK 100 million and warrants that can provide the Company with up to an additional SEK 100 million upon exercise (the “Directed Issue”), before issue costs. The Financing Agreement includes convertible loans of SEK 175 million and a loan facility of SEK 175 million, with Fenja Capital II A/S (“Fenja”) and a company associated company to Fenja as lenders (jointly, the “Lenders”). This amounts to a total of approximately SEK 665 million upon full exercise of warrants and convertibles and secures the financial runway for Cereno Scientific to reach its set milestones in Q4-2027. The Directed Issue has been directed to existing shareholders and external investors. Cereno Scientific has established a new advisory relationship with the investment bank Stifel. Background and Rationale for the Financing Agreement Cereno Scientific is advancing a pipeline of three pioneering and potentially disease-modifying drug candidates targeting rare cardiovascular and pulmonary diseases. The lead program CS1 has delivered positive Phase IIa data in pulmonary arterial hypertension (PAH) demonstrating a favorable safety and tolerability profile along with efficacy signals indicating disease modification. With FDA endorsement of the Phase IIb study design in a Type C-meeting and Fast Track designation granted, preparations are underway for a global, multi-center, placebo-controlled Phase IIb trial. The Company’s second HDAC inhibitor, CS014, has completed a Phase I first-in-human study with favorable safety and is well-tolerated at exposure levels predicted from non-clinical data to support disease-modifying effects. These findings support progression into Phase II in idiopathic pulmonary fibrosis (IPF). CS585, a selective prostacyclin (IP) receptor agonist, continues to progress in preclinical development through the Company’s collaboration with the University of Michigan, with rare thrombotic diseases under evaluation as potential indications. Over the past year, Cereno Scientific has reached several important milestones across its pipeline and strengthened its clinical and regulatory position. To ensure continued progress toward key milestones in Phase IIb for CS1 and Phase II for CS014 and maintain momentum in ongoing partnering activities, the Board of Directors has resolved to enter into the Financing Agreement. The loans under the Financing Agreement and proceeds from the Directed Issue are primarily intended for the execution of the global, multi-center, placebo-controlled Phase IIb trial of CS1 in pulmonary arterial hypertension (PAH). The financing further secures the Company’s ability to progress its broader pipeline toward key clinical and regulatory milestones while maintaining strategic and financial flexibility, including continued advancement of business development and partnering activities. The proceeds also include refinancing of the existing loans from Fenja, Arena Investor, and the two Danish investors Venusat ApS and SAJ Finans Aps (the “Existing Loans”). “This financing arrangement provides the resources required to execute the planned Phase IIb trial of CS1 in PAH. It also enables us to continue progressing our broader pipeline toward key clinical and regulatory milestones while maintaining the financial and strategic flexibility necessary at this stage of development. With this structure in place, we can move forward with strengthened clarity and focus on delivering on our clinical plans and supporting long-term value creation for patients and shareholders,” said Sten R. Sörensen, CEO and Board member, Cereno Scientific. Jeppe Øvlesen, Chairman of the Board at Cereno Scientific, comments “The Board of Directors views this financing arrangement as an important step in ensuring that Cereno Scientific has the means to advance CS1 into Phase IIb and continue developing the Company’s other programs toward upcoming milestones. The structure provides both stability and flexibility, supporting continued execution of the Company’s clinical strategy as well as its business development activities. We appreciate the confidence shown in the Company and remain committed to securing long-term value creation for all shareholders.” Main terms of the Financing Agreement The Financing Agreement is divided into three components: (i) the issue of convertible loans of SEK 175 million to the Lenders (the “Convertibles”), (ii) the issue of 9,593,901 warrants, without consideration, to the Lenders (the “Warrants”), and (iii) a loan facility of SEK 175 million (the “Loan Facility”). The Financing Agreement is subject to a customary arrangement fee, and the Convertibles and the Loan Facility are subject to interest deemed ,by the Board of Directors of the Company, to be on market terms. The Convertibles are issued by the Board of Directors of Cereno Scientific by virtue of the authorization granted by the Annual General Meeting on 10 June 2025. The Convertibles are due for repayment on 30 November 2027 and may be converted into B-shares in the Company by the Lenders up to a specified amount of maximum five (5) million shares each quarter through and including the first quarter of 2027. The conversion price is fixed at SEK 10.00, subject to customary recalculation principles. The Warrants are also issued by the Board of Directors of Cereno Scientific by virtue of the abovementioned authorization. Each Warrant entitles the holder to subscribe for one (1) new B-share in the Company until and including 30 November 2030 at a subscription price of SEK 12.00 per share, subject to recalculation principles including a dilution protection. Upon exercise of all Warrants, the Company is expected to receive additional issue proceeds of approximately SEK 115 million. The Company may draw on the Loan Facility from 1 April 2026 until and including 30 June 2027 to the extent that the Lenders have converted the Convertibles and divested the shares, and subject to the fulfilment of certain financial conditions. The Convertibles, the Warrants, and the Loan Facility under the Financing Agreement are distributed between the Lenders as follows: Fenja approximately 71.4 per cent and the company associated to Fenja approximately 28.6 per cent. The Directed Issue The Board of Directors of Cereno Scientific has, by virtue of the authorization from the Annual General Meeting, resolved on the Directed Issue. The Directed Issue consists of (i) a directed issue of 14,285,706 new B-shares with a total consideration of approximately SEK 100 million and (ii) a directed issue of 10,000,000 warrants of series 2025/26:1. The Directed Issue was subscribed by certain existing shareholders, including Cihan Punar, David Palm, Jan Butt, Andreas Ejlegård, Tim Rönnborg, Jonathan Ljuskvist, Louisa Razai och Andreas Fuentes-Rivera, Ringsökalven Förvaltning AB, Myrlid AS, Peyman Pournouri, Vasa Capital AB, as well as external investors, Niklas Estensson, and Bojan Markovic. The B-shares are issued at a subscription price of SEK 7 per share and reflect a premium of approximately two (2) per cent in relation to the volume-weighted average price (VWAP) of the Company’s B-shares during the last ten (10) trading days (including this day). The warrants of series 2025/26:1 are issued free of charge. The subscription price been negotiated at arm’s length and in consultation with the Lenders. In light of this, it is the Board of Directors’ assessment that the subscription price in the Directed Issue reflects the prevailing market conditions and should be considered to be at market terms. Each warrant of series 2025/26:1 entitles the holder to subscribe for one (1) new B-share in the Company from and including October 1, 2026, until and including December 31, 2026, at a subscription price of SEK 10.00 per share, subject to customary recalculation principles. Upon exercise of all warrants of series 2025/26:1, the Company will receive additional issue proceeds of SEK 100 million. Deviation from the Shareholders’ Preferential Rights The Board of Directors of Cereno Scientific has conducted an overall assessment and carefully evaluated the alternative of raising capital through an issue with preferential rights for the Company’s existing shareholders. The Board of Directors has furthermore, together with financial advisors, carefully evaluated various alternative financing alternatives for the Company. The Board of Directors has made the assessment that it was more beneficial for the Company and its shareholders to raise additional capital and refinance the Existing Loans through the Financing Agreement and the Directed Issue, with deviation from the shareholders’ preferential rights, considering that a rights issue: - would most likely have had to be carried out at less favorable terms for the Company and resulting in higher dilution; - would be significantly more time-consuming, which may risk that the Company misses out on potential growth opportunities; - would lead to significantly higher costs for the Company, mainly attributable to the necessary procurement of an underwriting consortium and costs for advisors; and - would expose the Company to higher market volatility, especially considering the current market conditions. Furthermore, the Directed Issue constitutes a requirement for the Financing Agreement, which further motivates the deviation from the shareholders’ preferential rights. In light of the foregoing, it is the Board of Directors’ overall assessment that the reasons for carrying out the Financing Agreement and the Directed Issue with sufficient strength outweigh the reasons supporting the general rule that issues should be carried out with preferential rights for existing shareholders, Furthermore, it is the Board of Directors’ assessment that the Financing Agreement and the Directed Issue are the most favorable alternatives for the Company to raise capital and refinance the Existing Loans. Shares, Share Capital, and Dilution Through the shares issued in the Directed Issue, the total number of shares in Cereno Scientific will increase by 14,285,706 B-shares, from 295,917,109 shares to 310,202,815 shares, of which 722,248 A-shares and 309,703,047 B-shares. The share capital will increase by SEK 1,428,570.60, from SEK 29,591,710.90 to SEK 31,020,281.50. The shares issued in the Directed Issue entail a dilution effect of approximately 4.61 per cent in relation to the number of shares and approximately 4.51 per cent in relation to the number of votes in the Company. Upon full exercise of the warrants of series 2025/26:1 issued in the Directed Issue, the number of shares in Cereno Scientific will increase by an additional 10,000,000 B-shares and the share capital will increase by an additional SEK 1,000,000. It will result in an additional dilution effect of up to approximately 3.12 per cent in relation to the number of shares and approximately 3.06 per cent in relation to the number of votes in the Company after the issue of B-shares in the Directed Issue. Upon full conversion of the Convertibles, the total number of shares in Cereno Scientific will increase by 17,500,000 B-shares and the share capital will increase by SEK 1,750,000, corresponding to an additional dilution effect of approximately 5.18 per cent in relation to the number of shares and approximately 5.08 per cent in relation to the number of votes in the Company. Upon full exercise of the Warrants issued under the Financing Agreement, the total number of shares in Cereno Scientific will increase by 9,593,901 B-shares and the share capital will increase by SEK 959,390.15, corresponding to an additional dilution effect of approximately 2.76 per cent in relation to the number of shares and approximately 2.71 per cent in relation to the number of votes in the Company. The new B-shares, the warrants of series 2025/26:1, the Warrants, and the Convertibles will be registered with the Swedish Companies Registration Office. The new B-shares will be admitted to trading on Nasdaq First North Growth Market, meanwhile the warrants of series 2026:1, the Warrants, and the Convertibles will not be admitted to trading. Engagement of Stifel as new advisory relationship Cereno Scientific has established a new advisory relationship with the investment bank Stifel, forming a partnership focused on supporting the Company’s long-term growth journey. Cereno Scientific engaged Stifel to act as sole and exclusive private placement agent in respect of the Financing Agreement. Advisers MAQS Advokatbyrå has been the legal adviser to the Company. Stifel acted as sole and exclusive private placement agent in respect of the Financing Agreement. For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 73- 236 62 46 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. The company’s innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the fullest. Lead candidate CS1 is an HDAC inhibitor that works through epigenetic modulation and represents a novel therapeutic approach by targeting the root mechanisms of the pulmonary arterial hypertension (PAH). CS1 is a well-tolerated oral therapy with a favorable safety profile that has shown encouraging efficacy signals of reverse vascular remodeling and improvement of right heart function as observed in a Phase IIa trial in patients with PAH. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. CS014, a new chemical entity with disease-modifying potential, showed favorable safety and tolerability profile in a Phase I trial. CS014 is a HDAC inhibitor with a multimodal mechanism of action as an epigenetic modulator having the potential to address the underlying pathophysiology of rare cardiovascular and pulmonary diseases with high unmet needs such as idiopathic pulmonary fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like thrombosis prevention without increased risk of bleeding and pulmonary hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Company’s Certified Adviser is DNB Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Important information The release, announcement or distribution of this press release may, in certain jurisdictions, be subject to restrictions by law. The recipients of this press release in jurisdictions where this press release has been published or distributed shall inform themselves of and follow such restrictions. The recipient of this press release is responsible for using this press release, and the information contained herein, in accordance with applicable rules in each jurisdiction. This press release does not constitute an offer to sell or an offer, or the solicitation of an offer, to acquire or subscribe for shares or other securities issued by the Company, neither by the Company or anyone else, in any jurisdiction where such offer or invitation would be illegal prior to registration, exemption from registration or qualification under the securities laws of such jurisdiction. This press release is not a prospectus for the purposes of Regulation (EU) 2017/1129 (the “Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. The Company has not authorized any offer to the public of shares or other securities in any member state of the European Economic Area (“EEA”) and no prospectus has been or will be prepared in connection with the Financing Agreement or the Directed Issue. In any EEA Member State, this communication is only addressed to and is only directed at “qualified investors” in that Member State within the meaning of the Prospectus Regulation. This press release does not constitute or form part of an offer or solicitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the US Securities Act of 1933, as amended (the “Securities Act”), and may not be offered or sold within the United States absent registration or an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of the securities in the United States. The information in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, within or into the Unites States, Australia, Belarus, Canada, Hong Kong, Japan, New Zeeland, Russia, Switzerland, Singapore, South Africa, South Korea, or in any other jurisdiction where such announcement, publication or distribution of the information would not comply with applicable laws and regulations or where such actions are subject to legal restrictions or would require additional registration or other measures than what is required under Swedish law. Actions taken in violation of this instruction may constitute a crime against applicable securities laws and regulations. In the United Kingdom, this document and any other materials in relation to the securities described herein is only being distributed to, and is only directed at, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, “qualified investors” who are (i) persons having professional experience in matters relating to investments who fall within the definition of “investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”); or (ii) high net worth entities falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as “relevant persons”). In the United Kingdom, any investment or investment activity to which this communication relates is available only to, and will be engaged in only with, relevant persons. Persons who are not relevant persons should not take any action on the basis of this press release and should not act or rely on it. This announcement does not identify or suggest, or purport to identify or suggest, the risks (direct or indirect) that may be associated with an investment in the new shares. Any investment decision to acquire or subscribe for shares in connection with the Share Issue must be made on the basis of all publicly available information relating to the Company and the Company’s shares. This press release does not constitute a recommendation for any investors’ decisions regarding the Directed Issue. Each investor or potential investor should conduct a self-examination, analysis and evaluation of the business and information described in this press release and any publicly available information. The price and value of the securities can decrease as well as increase. Achieved results do not provide guidance for future results. Neither the contents of the Company’s website nor any other website accessible through hyperlinks on the Company’s website are incorporated into or form part of this press release. Failure to follow these instructions may result in a breach of the Securities Act or applicable laws in other jurisdictions. Forward-looking statements This press release contains forward-looking statements that reflect the Company's intentions, beliefs, or current expectations about and targets for the Company's future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that are not historical facts and may be identified by words such as "believe", "expect", "anticipate", "intend", "may", "plan", "estimate", "will", "should", "could", "aim" or "might", or, in each case, their negative, or similar expressions. The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions. Although the Company believes that the expectations reflected in these forward-looking statements are reasonable, it can give no assurances that they will materialize or prove to be correct. Because these statements are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcome could differ materially from those set out in the forward-looking statements as a result of many factors. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied in this release by such forward-looking statements. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are free from errors and readers of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements that are expressly or implicitly contained herein speak only as of its date and are subject to change without notice. Neither the Company nor anyone else undertake to review, update, confirm or to release publicly any revisions to any forward-looking statements to reflect events that occur or circumstances that arise in relation to the content of this press release, unless it is required by law or Nasdaq Stockholm’s rule book for issuers. Information to distributors Solely for the purposes of the product governance requirements contained within: (a) EU Directive 2014/65/EU on markets in financial instruments, as amended (“MiFID II”); (b) Articles 9 and 10 of Commission Delegated Directive (EU) 2017/593 supplementing MiFID II; and (c) local implementing measures (together, the “MiFID II Product Governance Requirements”), and disclaiming all and any liability, whether arising in tort, contract or otherwise, which any “manufacturer” (for the purposes of the MiFID II Product Governance Requirements) may otherwise have with respect thereto, the shares have been subject to a product approval process, which has determined that such shares are: (i) compatible with an end target market of retail investors and investors who meet the criteria of professional clients and eligible counterparties, each as defined in MiFID II; and (ii) eligible for distribution through all distribution channels as are permitted by MiFID II (the “Target Market Assessment”). Notwithstanding the Target Market Assessment, Distributors should note that: the price of the shares in the Company may decline and investors could lose all or part of their investment; the shares in the Company offer no guaranteed income and no capital protection; and an investment in the shares in the Company is compatible only with investors who do not need a guaranteed income or capital protection, who (either alone or in conjunction with an appropriate financial or other adviser) are capable of evaluating the merits and risks of such an investment and who have sufficient resources to be able to bear any losses that may result therefrom. The Target Market Assessment is without prejudice to the requirements of any contractual, legal or regulatory selling restrictions in relation to the Rights Issue. For the avoidance of doubt, the Target Market Assessment does not constitute: (a) an assessment of suitability or appropriateness for the purposes of MiFID II; or (b) a recommendation to any investor or group of investors to invest in, or purchase, or take any other action whatsoever with respect to the shares in the Company. Each distributor is responsible for undertaking its own Target Market Assessment in respect of the shares in the Company and determining appropriate distribution channels. Read PDF Share