"创新药九死一生，罕见病药物尤其如此。有了市场独占期制度，一旦成功，这类药物就可以享受到独 占红利。"国内罕见病药企北海康成创始人、董事长兼首席执行官薛群在接受智通财经记者采访时表 示，国际上很多国家都有罕见病的市场独占期制度，比如美国是7年，欧盟是9年，包括北海康成在内， 多年来国内也有很多力量在推动这一制度的确立，如今条例正式公布，称得上里程碑式时刻，将鼓励更 多药企投入到更小众的罕见病领域，也有望引导行业实现"反内卷"。 凯西中国总裁兼总经理邓浩青表示，此次条例的修订将进一步鼓励创新，支持以临床价值为导向的研 发。条例还明确规定了药品上市的快速审评通道，加快新药好药上市，尽快惠及患者。其中，对符合条 件的罕见病药品给予不超过7年的市场独占期，这不仅和国际标准接轨，也给深耕罕见病领域的企业打 了一剂强心针，让公司感受到了政府鼓励"真创新"、加速罕见病患者药物可及的满满心意。 邓浩青介绍，目前，借助海南博鳌乐城先行先试政策，公司已率先落地了两款罕见病产品，还有7款罕 见病治疗药物待进入中国，其中不乏目前国内该适应证唯一的治疗选择，希望乘着中国政策的东风，将 这些产品尽快带入中国，让罕见病患者尽早用上创新药， ...

Group 1 - The company North Sea Kang Cheng-B (01228) announced the grant of a total of 6,372,575 stock options to 30 option grantees under its post-IPO stock option plan [1] - Additionally, the company granted a total of 6,372,575 restricted stock units to 28 grantees under its post-IPO restricted stock unit plan [1] - The exercise price for the granted stock options is set at HKD 2.32 per share [1]

智通财经APP讯，北海康成-B(01228)公布，于2026年1月12日，公司根据首次公开发售后购股权计划向 30名购股权承授人授出合共6,372,575份购股权及根据首次公开发售后受限制股份单位计划向28名受限制 股份单位承授人授出合共6,372,575份受限制股份单位。授出的购股权的行使价为每股2.32港元。 ...

格隆汇1月12日丨北海康成-B(01228.HK)公告，于2026年1月12日，公司根据首次公开发售后购股权计划 向30名购股权承授人授出合共6,372,575份购股权及根据首次公开发售后受限制股份单位计划向28名受限 制股份单位承授人授出合共6,372,575份受限制股份单位。 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或完 整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因依賴該等內 容而引致的任何損失承擔任何責任。 CANbridge Pharmaceuticals Inc. 北海康成製藥有限公司 （於開曼群島註冊成立的有限公司） （股份代號：1228） 授出購股權及受限制股份單位 本公告由北海康成製藥有限公司（「本公司」）作出。於2026年1月12日，本公司根據首次公開發售後購 股權計劃向30名購股權承授人授出合共6,372,575份購股權及根據首次公開發售後受限制股份單位計 劃向28名受限制股份單位承授人授出合共6,372,575份受限制股份單位。 授出購股權 於2026年1月12日（交易時段後），本公司根據首次公開發售後購股權計劃向30名購股權承授人授出合 共6,372,575份購股權，惟須待購股權承授人接納後方可作實。 授出購股權的詳情載列如下： 授出日期： 2026年1月12日 購股權承授人數量： 30名（其中24名為非關連購股權承授人，4名為董事購股權承授人及2 名為服務供應商購股權承授人） 授出的購股 ...

FF301 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年12月31日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 北海康成製藥有限公司（於開曼群島註冊成立之有限公司） 呈交日期: 2026年1月7日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 01228 | 說明 | | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | | 50,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.00001 | USD | ...

Core Insights - The innovative drug sector is experiencing a significant bull market, with the entry threshold for top-performing stocks raised considerably [1] - In 2024, the median stock price increase for the top 10 innovative drug companies was 57.9%, while in 2025, this surged to a median increase of 495.41%, with the highest increase reaching 1824% [2] Group 1: Top Performing Companies - The top-performing stock in 2025 was Beihai Kangcheng, with an astonishing annual increase of 1824%, surprising many in the market [4] - Following Beihai Kangcheng, the second highest was Sanleaf Biotech, which saw an increase of 870%, despite facing significant operational challenges [10] - Yaojie Ankang ranked third with a 773% increase, although its valuation raised concerns due to its limited clinical progress [12] - Heber Pharmaceuticals achieved a 553% increase, driven by its dual-engine model of R&D and business development [16] - Xuan Bamboo Biotech, a newly listed company, experienced a 507% increase, attributed to its new stock status and positive clinical data [20] Group 2: Market Dynamics and Trends - The market has seen a trend of speculative trading, with some companies experiencing price surges not necessarily backed by fundamental improvements [4] - The rise of companies like Heber Pharmaceuticals and Rongchang Biotech illustrates that long-term undervalued firms can achieve significant valuation recovery through continuous R&D and commercialization breakthroughs [4][30] - The innovative drug sector's growth is heavily influenced by liquidity and market sentiment, with many price increases based on speculative expectations rather than solid fundamentals [39] Group 3: Company-Specific Developments - Beihai Kangcheng's stock price recovery was linked to strategic capital injections, resolving its cash flow crisis [7] - Sanleaf Biotech's stock price rebound was primarily driven by its RSV vaccine pipeline, despite facing significant financial pressures [10][11] - Yaojie Ankang's rapid valuation increase raised questions about its sustainability, given its limited clinical advancements [13][14] - Heber Pharmaceuticals' growth was supported by strategic partnerships and a robust technology platform, enhancing investor confidence [18][19] - Rongchang Biotech's stock performance was bolstered by successful product approvals and strategic financing, improving its market outlook [31]

北海康成创始人、董事长兼首席执行官薛群日前在接受中国证券报记者专访时表示，罕见病创新药市场 是"蓝海中的蓝海"，国内存在大量未被满足的临床需求。凭借二十余年深耕积累，公司已构建起多元产 品矩阵，未来将以"双核驱动"战略深化全球创新布局，借力政策红利与产业协同，让更多罕见病患者享 受到创新药带来的希望。 逾二十载深耕筑根基 薛群介绍，公司的三款上市产品已精准填补多个临床空白：海芮思和迈芮倍两款产品是公司通过专利买 断引进后在国内上市，填补了黏多糖贮积症Ⅱ型（MPS Ⅱ）、阿拉杰里（ALGS）综合征等领域的临床 空白，还刷新了相关适应症的国家诊疗共识与指南；戈芮宁于2025年5月获批上市，是我国首个本土自 主研发生产的针对戈谢病的酶替代1类创新药。 政策赋能破困局 在罕见病创新药研发的高成本赛道上，政策支持成为破解产业困境的关键力量。薛群直言，公司核心产 品戈芮宁的成功上市，既离不开企业直面研发挑战的坚守，更得益于国家生物制品分段生产试点政策的 精准赋能。 戈芮宁的研发历程曾深陷高成本困境。作为国内首个本土自主研发的戈谢病酶替代治疗药物，其采 用"上海外高桥（600648）基地生产原液+江苏无锡GMP厂房制剂罐装 ...

Core Insights - The company, Beihai Kangcheng, has established itself as a global biopharmaceutical firm focused on rare diseases, with three approved products and seven in development [1][2] - The founder, Xue Qun, emphasizes the unmet clinical needs in the rare disease sector as a significant opportunity for growth and innovation [4] Company Development - Beihai Kangcheng was founded in 2012 after Xue Qun's decade-long experience in the rare disease field, initially focusing on oncology due to funding challenges [1] - A pivotal moment for the company was in 2018 when the Chinese government released a rare disease directory, leading to strategic partnerships and significant funding [1][3] Product Portfolio - The company has three marketed products that address clinical gaps in conditions such as MPS II and ALGS, with the first domestically developed enzyme replacement therapy for Gaucher disease, Gorenin, expected to be approved by May 2025 [2][4] Policy Support - Government policies have played a crucial role in alleviating challenges in rare disease drug development, particularly through the segmented production pilot policy that supports innovative biopharmaceuticals [3][5] - Gorenin's successful development benefited from this policy, allowing for a segmented production model that meets clinical needs while navigating regulatory hurdles [3][5] Market Strategy - The company is entering a 3.0 development phase, implementing a "dual-core drive" strategy to solidify its leadership in the domestic rare disease market while expanding internationally [7] - A strategic partnership with Baiyang Pharmaceutical aims to enhance commercialization efforts and leverage each other's strengths in the rare disease sector [7][8] Future Outlook - The company anticipates a significant market expansion for rare disease drugs, particularly with the inclusion of Gorenin in the first commercial insurance innovation drug directory set to take effect in January 2026 [5][6] - Xue Qun envisions a collaborative ecosystem that integrates diagnostics and patient education to improve awareness and treatment of rare diseases [8]

北海康成创始人、董事长兼首席执行官薛群日前在接受中国证券报记者专访时表示，罕见病创新药市场 是"蓝海中的蓝海"，国内存在大量未被满足的临床需求。凭借二十余年深耕积累，公司已构建起多元产 品矩阵，未来将以"双核驱动"战略深化全球创新布局，借力政策红利与产业协同，让更多罕见病患者享 受到创新药带来的希望。 逾二十载深耕筑根基 作为专注罕见疾病领域的全球化生物制药公司，北海康成如今已拥有3个已获批上市产品和7个在研药 物。 在2012年创建北海康成之前，薛群已在罕见病领域深耕十年，其中有四五年时间以拓荒者的身份在国内 推广，彼时国内罕见病领域尚处启蒙阶段。2011年，他任职的健赞公司被收购，薛群表示，出于对更具 挑战性、更高节奏创业环境的追求，他当时主动选择离开。"在我看来，国内存在大量未被满足的临床 需求，是更有作为的创业沃土。"基于这一判断，北海康成应运而生。 创业初期的道路并不平坦。"受融资难题限制，无法直接布局罕见病赛道。"薛群坦言，当时公司的首要 目标是活下来，因此早期管线均围绕肿瘤领域展开。2018年成为公司发展的关键转折点，行业风口迎来 集中爆发：国家五部门联合发布首批罕见病目录，将121种疾病纳入其 ...