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康诺亚(2162.HK):关注下半年商业化进展及医保谈判结果
Ge Long Hui· 2025-08-29 18:53
CM310 上半年实现1.69 亿元销售,维持首年销售目标5 亿元不变,下半年积极准备医保谈判工作: CM310 商业化正在稳步推进中,截至2025 年8 月,公司商业团队规模达到360+人,已覆盖30 省, 240+城市,覆盖医院超1,400 家。公司表示,上半年CM310 在鼻科的放量(两个适应症:鼻窦炎伴鼻息 肉、过敏性皮炎)略超其在皮肤科放量(特应性皮炎适应症),下半年公司商业化工作重心为医院准 入、加大皮肤科的推广力度以及积极准备国家医保谈判。公司对于CM310多个适应症同时纳入医保充 满信心,我们认为至少特应性皮炎及鼻窦炎伴鼻息肉两项适应症应该可轻松纳入医保。此外,管理层认 为,尽管近期也有其他国产IL4R 递交NDA,但CM310 仍然具有先进的工艺开发及大规模生产优势从而 维持短中期内极具竞争力的价格,因此管理层维持对CM310 于今年实现5 亿元销售,长期实现50 亿元 销售峰值的目标。剂型及适应症拓展方面,自动注射笔有望于4Q25 获批,青少年AD 及结节性痒疹均 有望于1H26 申报上市。 机构:浦银国际 研究员:阳景/胡泽宇 1H25 归母净亏损好于预期。维持"买入"评级,上调目标价。 ...
康诺亚-B(2162.HK):持续深耕潜力管线 司普奇拜单抗商业化快速放量
Ge Long Hui· 2025-08-29 18:53
司普奇拜单抗商业化快速放量。 机构:光大证券 研究员:王明瑞/张瀚予 事件:公司发布2025 年半年报,实现营业收入4.99 亿元,同比+812%,其中药品销售收入约1.7 亿元, 公司对外合作的收入约3.3 亿人民币;扣非归母净利润为-0.79 亿元。 点评: CM313:抗CD38 人源化高效单抗,持续开展多项自免疾病研究,ITP(免疫性血小板减少症)、IgAN (IgA 肾病)等多项临床II 期研究快速推进中。 盈利预测、估值与评级: 因为25H1 公司司普奇拜单抗的实际销售收入超过预期收入,因此我们上调2025年归母净利润预测 为-6.24 亿元(原预测为-7.37 亿元);考虑到国内及海外研发费用进一步扩大,下调2026 年归母净利润 预测为-4.34 亿元(原预测为-3.04 亿元);新增2027 年归母净利润预测为-0.64 亿元。公司核心产品司 普奇拜单抗获批上市后销售迅速放量;后续管线布局广阔,覆盖患者人群庞大,且研发进度领先。基于 以上因素,我们维持"买入"评级。 风险提示:研发进度不达预期的风险;销售情况不达预期的风险;国际合作不达预期的风险。 25H1 司普奇拜单抗销售收入约1.7 亿 ...
康诺亚-B(02162):关注下半年商业化进展及医保谈判结果
SPDB International· 2025-08-29 11:06
Investment Rating - The report maintains a "Buy" rating for the company and raises the target price to HKD 77.0, indicating a potential upside of 16% from the current price of HKD 66.5 [2][5][7]. Core Insights - The company's net loss attributable to shareholders for the first half of 2025 was better than expected, with revenue reaching RMB 499 million, a year-on-year increase of 812.1%. Product revenue was RMB 169 million, while collaboration revenue was RMB 329 million, up 502.6% year-on-year [5][7]. - The company is focusing on the commercialization of CM310 and preparing for national medical insurance negotiations, with confidence in multiple indications being included in the insurance scheme [5][7]. - The next-generation core pipeline drug, CM512, is being prioritized for development, showing promising safety and efficacy in preclinical studies [5][7]. Financial Performance - For 1H25, the company reported a net loss of RMB 78.84 million, significantly reduced from RMB 337 million in 1H24, primarily due to better-than-expected collaboration revenue and improved gross margins [5][7]. - The company’s cash position improved to RMB 2.8 billion as of June 30, 2025, up from RMB 2.16 billion at the end of 2024, aided by a successful placement in June [5][7]. - Revenue projections for the upcoming years show significant growth, with expected revenues of RMB 823 million in 2025, RMB 1.5 billion in 2026, and RMB 2.3 billion in 2027, reflecting year-on-year growth rates of 92%, 82%, and 54% respectively [7][9].
康诺亚-B(02162):2025年半年报点评:持续深耕潜力管线,司普奇拜单抗商业化快速放量
EBSCN· 2025-08-29 07:15
2025 年 8 月 29 日 公司研究 持续深耕潜力管线,司普奇拜单抗商业化快速放量 ——康诺亚-B(2162.HK)2025 年半年报点评 要点 事件:公司发布 2025 年半年报,实现营业收入 4.99 亿元,同比+812%,其中 药品销售收入约 1.7 亿元,公司对外合作的收入约 3.3 亿人民币;扣非归母净利 润为-0.79 亿元。 点评: 司普奇拜单抗商业化快速放量。 25H1 司普奇拜单抗销售收入约 1.7 亿元,公司预测其峰值销售收入将突破 50 亿元。作为国内首个治疗慢性鼻窦炎伴鼻息肉、全球首个治疗季节性过敏性鼻炎 的 IL-4Rα 抗体药物,司普奇拜单抗有效满足了未被满足的治疗市场。公司聚焦 2 型炎症相关疾病领域,打造专业自免领域销售团队;推动渠道与市场准入,提 升药品可及性,惠及更多患者。截至 2025 年 8 月,商业化团队规模逾 360 人, 并将进一步持续扩增;药品已覆盖 30 省,240+城市,覆盖医院超 1,400 家,持 续产出医院 1,100+,可院内用药医院超 300 家。 持续深耕潜力管线。 盈利预测、估值与评级: 因为25H1公司司普奇拜单抗的实际销售收入超过预期收 ...
康诺亚-B(02162):司普奇拜单抗销售快速增长,早期管线全球价值凸显
HTSC· 2025-08-28 08:32
证券研究报告 港股通 康诺亚-B (2162 HK) 司普奇拜单抗销售快速增长,早期管 线全球价值凸显 2025 年 8 月 28 日│中国香港 生物医药 8 月 26 日,公司公告 1H25 业绩,营收 4.99 亿元(+812%yoy)。司普奇 拜单抗 1H25 收入约 1.69 亿元,在 AD 领域疗效安全性优势明显、竞争力 强劲,在鼻科独家适应症带动下,销售额快速增长,公司拟参与 2025 医保 谈判,有望提升可及性。同时公司多条早期管线全球潜力强劲,多项催化有 望兑现,我们预计 CMG901 有望 2026 年报产,CM512 有望 2H25 读出 AD 临床数据。维持"买入"。 司普奇拜单抗销售快步攀升 1H25 司普奇拜单抗销售额约 1.69 亿元,看好后续增长:1)产品较度普利 尤单抗疗效优势明显,有望持续渗透自费患者市场;2)秋季过敏季临近, 在此前春季过敏季取得的良好基础上,2H25 SAR 销售额增长可期;3)公 司拟参与 2025 年国谈,若纳入医保或提升药物可及性;4)注射笔剂型在 2024 年 10 月申报上市,有望 2025 年内获批,提升给药便捷性。 CM512:潜在 II 型 ...
里昂:升康诺亚-B目标价至78港元 上半年业绩超预期
Zhi Tong Cai Jing· 2025-08-28 08:04
里昂发布研报称,康诺亚-B(02162)上半年业绩超出市场预期,Stapokibart销售额达1.69亿元人民币,高 于先前指引的1.5亿元人民币。虽然CM512潜在的二次对外授权机会推动近期股价上升,但公司优先聚 焦国内市场的产品开发策略令市场稍为失望。考虑到CM512展现的积极临床进展及成为同类最佳药物 的潜力,该行将康诺亚的目标价由65港元上调至78港元,评级由高度确信跑赢大市调整至跑赢大市。 ...
里昂:升康诺亚-B(02162)目标价至78港元 上半年业绩超预期
智通财经网· 2025-08-28 08:00
智通财经APP获悉,里昂发布研报称,康诺亚-B(02162)上半年业绩超出市场预期,Stapokibart销售额达 1.69亿元人民币,高于先前指引的1.5亿元人民币。虽然CM512潜在的二次对外授权机会推动近期股价 上升,但公司优先聚焦国内市场的产品开发策略令市场稍为失望。考虑到CM512展现的积极临床进展 及成为同类最佳药物的潜力,该行将康诺亚的目标价由65港元上调至78港元,评级由高度确信跑赢大市 调整至跑赢大市。 ...
医药行业周报:出海浪潮下,关注自免双抗的潜在BD布局机会-20250810
Hua Yuan Zheng Quan· 2025-08-10 07:36
Investment Rating - The investment rating for the pharmaceutical industry is "Positive" (maintained) [4] Core Views - The report emphasizes the potential opportunities in the autoimmune dual-antibody sector amidst the ongoing trend of international expansion. It highlights the increasing interest from multinational corporations (MNCs) in Chinese innovative drugs, particularly in the context of patent cliffs faced by leading MNCs [3][8] - The report suggests that the pharmaceutical sector is poised for growth in 2025, driven by several factors including the successful transition from traditional to innovative growth drivers, the increasing capabilities of Chinese companies in international markets, and the rising demand due to an aging population [4][47] Summary by Sections Market Performance - From August 4 to August 8, the pharmaceutical index declined by 0.84%, underperforming the CSI 300 index by 2.07%. Notable gainers included Nanmo Biology (+42.48%), Haichen Pharmaceutical (+41.29%), and Sino Medical (+39.52%). Conversely, Nanxin Pharmaceutical (-18.5%) and Qizheng Tibetan Medicine (-16.11%) were among the largest decliners [5][24] BD Opportunities - The report notes a surge in BD (business development) transactions, particularly in the autoimmune sector, with a total of over 100 license-out transactions in China from January 1 to August 7, 2025, amounting to $840.5 billion. The focus of these transactions has been primarily on oncology and metabolic fields, with a notable lack of activity in the autoimmune sector [9][8] Investment Recommendations - The report recommends focusing on innovative drugs and medical devices, particularly those with low valuations and potential for marginal improvement. Key companies to watch include Heng Rui Pharmaceutical, Keren Pharmaceutical, and Innovent Biologics [4][49] - It also highlights the importance of the aging population and the increasing demand for chronic disease treatments, suggesting that companies like Kunming Pharmaceutical and Yuyue Medical could benefit from this trend [48][47] Valuation Insights - As of August 8, 2025, the overall PE valuation for the pharmaceutical sector stands at 38.77X, indicating that the sector is still at a relatively low historical valuation compared to other sectors [36][47] Future Outlook - The report anticipates a rebound in the pharmaceutical sector in 2025, driven by innovative drugs and the ongoing internationalization of Chinese pharmaceutical companies. It emphasizes the need to focus on sectors with structural growth potential, such as innovative drugs, medical devices, and the aging population market [47][48]
自免领域迈入双抗时代,康诺亚(02162)成下一代自免药王的领路人?
智通财经网· 2025-08-02 02:36
Group 1 - The innovative drug market in China is experiencing a surge, with the total amount of License out transactions for innovative drugs expected to reach nearly $66 billion by the first half of 2025, surpassing the total BD transaction amount for 2024 [1] - The immune system drug market is the second largest prescription drug market globally, with an increasing proportion of BD transactions. The share of tumor pipeline overseas licensing transactions decreased from 72% in 2023 to 61% in 2024, while the share of metabolic and autoimmune drugs increased from 12% to 25% [1][2] - The autoimmune disease market is gaining attention due to its large unmet medical needs, with the global treatment market projected to reach $119.35 billion by 2027 [2] Group 2 - The immune drug market has evolved since the introduction of TNFα inhibitors, with new targets emerging, including interleukin classes and JAK/Tyk2 inhibitors. The competition in clinical and commercial stages is intensifying, with a focus on precision treatment [5][7] - Bispecific antibody drugs are gaining traction in the treatment of autoimmune diseases, offering the ability to target two different antigens simultaneously, which may lead to more effective disease management [7][8] - The first bispecific antibody drugs in the autoimmune field are expected to create a new wave of growth, with companies like 康诺亚 leading the development [23] Group 3 - 康诺亚's core product, CM310, is the first domestically approved IL-4Rα antibody drug, with significant market potential in treating various allergic diseases. Its success in entering the medical insurance negotiation at the end of the year is crucial for its market performance [13][16] - The company has a strong pipeline in the autoimmune field, with CM310 expected to generate substantial sales, potentially reaching 5 billion yuan by 2030 [23] - 康诺亚 is also advancing in the oncology sector with its ADC drug CMG901, which is in the lead for clinical development among competitors [19][23] Group 4 - 康诺亚 has successfully engaged in multiple NewCo agreements, indicating its potential for international expansion and valuation growth in the innovative drug sector [22] - The NewCo model provides a favorable environment for domestic biotech companies, allowing them to secure cash flow and mitigate risks while advancing their research and clinical trials [22] - The recent licensing deal with GSK, which includes a $500 million upfront payment and up to $12 billion in milestone payments, highlights 康诺亚's strong position in the market [12]
康诺亚-B(02162)、Moonshot Holdings Limited与牵头账簿管理人及联席账簿管理人订立配售及认购协议
智通财经网· 2025-06-11 00:17
Core Viewpoint - 康诺亚-B (02162) has entered into a placement and subscription agreement to sell and issue shares, aiming to raise approximately HKD 854 million for various development and operational purposes [1][2]. Group 1: Share Placement and Subscription - The total number of shares to be placed is 21.6 million, representing approximately 7.72% of the company's issued shares as of the announcement date [2]. - The number of subscription shares is 19 million, accounting for about 6.36% of the expanded share capital post-placement and subscription [2]. - The placement price is set at HKD 45.48 per share, which is a discount of approximately 6.52% compared to the closing price of HKD 48.65 on June 10, 2025 [2]. Group 2: Use of Proceeds - The net proceeds from the subscription, estimated to be around HKD 854 million after deducting commissions and estimated expenses, will be allocated for: - Research and development expenses for CM512, CM518D1, and other pipeline projects [2]. - Commercialization of the drug Siplizumab [2]. - Capital expenditures for manufacturing and research facilities [2]. - General corporate and operational funding [2].