Investing.comCodex · 实盘不做把握 5/10
北京时间·🕒 发布 07-23 19:36:36时区推断·⟳ 抓取 07-23 19:38:10·⚡ 决策 07-24 01:05:43 +5h27m·95.7 天前
海思科PNH新药思普可泮获中国NMPA上市批准，Nuvectis持有部分海外权益
思普可泮获批用于既往未接受补体抑制剂治疗的成人PNH患者，原文披露59.5%患者达到12 g/dL血红蛋白目标、94.6%无需输血，临床数据明确正面。
📄 原文Investing.com↗ 原文
China approves Nuvectis’ ciprocopan for blood disorder PNH
Google raises annual spending estimates amid rapid AI infrastructure build-out FORT LEE, N.J. - Nuvectis Pharma, Inc. (…
不做 海思科（002653.SZ）
获批利好明确但PNH罕见病量级相对约800亿元市值不够清晰，且MAA在审已公开、股价前期剧烈交易，追多edge不足。
不做 Nuvectis Pharma（NVCT.US）
中国商业化权益不归NVCT，当前更多是机制验证；海外注册和销售仍未落地，不做。
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)
研究档案
消息传播链
- Nuvectis披露从海思科获得NXP100等海外权益，并说明中国PNH两项MAA在审。
- 海思科公告国家药监局批准琥珀酸思普可泮片上市。市场反应:海思科此前7月15日至17日已连续大幅波动，获批前存在预期交易。
- 英文稿扩散海思科1类创新药获批上市信息。
- 美股端将该获批表述为Nuvectis相关资产在中国获批。
关键理由
- 思普可泮获批用于既往未接受补体抑制剂治疗的成人PNH患者，原文披露59.5%患者达到12 g/dL血红蛋白目标、94.6%无需输血，临床数据明确正面。
- 海思科是中国开发、申报和商业化主体，Nuvectis仅持有大中华、印度及部分东南亚以外权益，因此中国获批对NVCT主要是临床验证而非直接收入。
- 量级上PNH为罕见病，海思科市值约800亿元人民币量级，且MAA在审和6月授权交易已提前披露，单一适应症获批的短线新增业绩弹性不足以追多。
主要风险
- 海思科获批前股价已在7月15日至17日出现+9.45%、+6.83%、-10.00%的剧烈波动，存在预期交易和兑现风险。
- NVCT尚需在海外推进开发和注册，中国获批不等于其立即产生销售收入。
反向证据
- 做多前查反向 · 来源 web · 日期 2026-06-22 · 影响 weakens
Nuvectis此前已披露中国PNH MAA在审，海思科近期股价已剧烈波动，削弱获批当日追多edge。
检索:海思科 思普可泮 获批 股价 7月 2026 MAA 在审 原文 ↗
原文全文
展开原文 · 2,012 字
Google raises annual spending estimates amid rapid AI infrastructure build-out
FORT LEE, N.J. - Nuvectis Pharma, Inc. (NASDAQ:NVCT) announced today that ciprocopan, a once-daily oral complement Factor B inhibitor, received marketing approval from China’s National Medicinal Products Administration for treating patients with Paroxysmal Nocturnal Hemoglobinuria who have not previously received complement inhibitor treatment.
The approval marks the first global authorization for a once-daily oral complement Factor B inhibitor, according to a press release statement from the clinical-stage biopharmaceutical company. Ciprocopan is also known as NXP100.
The approval was based on a Phase 3 head-to-head study comparing ciprocopan to Soliris (eculizumab) in treatment-naive PNH patients. The study met all primary and secondary endpoints. Results showed 59.5% of ciprocopan patients reached a hemoglobin target of 12 g/dL compared to 8.3% for eculizumab. Hemoglobin increased approximately 5.0 g/dL from baseline with ciprocopan versus 2.2 g/dL with eculizumab. Additionally, 94.6% of ciprocopan patients required no transfusions during the study compared to 69.4% of eculizumab patients.
The study demonstrated a favorable safety profile with no adverse events leading to treatment discontinuation or study withdrawal.
Haisco independently developed ciprocopan and handles its development, regulatory approvals, and commercialization in China. Under a June 2026 exclusive license agreement, Nuvectis holds exclusive rights to develop and commercialize ciprocopan outside Greater China, India, and certain Southeast Asian countries.
A separate ciprocopan application for patients with PNH previously treated with anti-C5 therapies is currently under review in China.
Nuvectis is a clinical-stage biopharmaceutical company focused on developing therapies for complement-related conditions and oncology.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
FORT LEE, N.J. - Nuvectis Pharma, Inc. (NASDAQ:NVCT) announced today that ciprocopan, a once-daily oral complement Factor B inhibitor, received marketing approval from China’s National Medicinal Products Administration for treating patients with Paroxysmal Nocturnal Hemoglobinuria who have not previously received complement inhibitor treatment.
The approval marks the first global authorization for a once-daily oral complement Factor B inhibitor, according to a press release statement from the clinical-stage biopharmaceutical company. Ciprocopan is also known as NXP100.
The approval was based on a Phase 3 head-to-head study comparing ciprocopan to Soliris (eculizumab) in treatment-naive PNH patients. The study met all primary and secondary endpoints. Results showed 59.5% of ciprocopan patients reached a hemoglobin target of 12 g/dL compared to 8.3% for eculizumab. Hemoglobin increased approximately 5.0 g/dL from baseline with ciprocopan versus 2.2 g/dL with eculizumab. Additionally, 94.6% of ciprocopan patients required no transfusions during the study compared to 69.4% of eculizumab patients.
The study demonstrated a favorable safety profile with no adverse events leading to treatment discontinuation or study withdrawal.
Haisco independently developed ciprocopan and handles its development, regulatory approvals, and commercialization in China. Under a June 2026 exclusive license agreement, Nuvectis holds exclusive rights to develop and commercialize ciprocopan outside Greater China, India, and certain Southeast Asian countries.
A separate ciprocopan application for patients with PNH previously treated with anti-C5 therapies is currently under review in China.
Nuvectis is a clinical-stage biopharmaceutical company focused on developing therapies for complement-related conditions and oncology.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
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