炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 近日，劲方医药科技（上海）股份有限公司（以下简称"劲方医药"）向港交所递交IPO文件，拟通过 18A规则于港交所主板上市，中信证券为其独家保荐人。此前，公司曾于今年1月首次递表，本次为前 次招股书失效后的第二次递表。 招股书显示，劲方医药成立于2017年，公司专注于肿瘤、自体免疫和炎症性疾病领域的创新药物开发。 与诸多寻求港股上市的18A生物医药公司不同，劲方医药目前已拥有商业化产品，公司核心产品小分子 选择性KRAS G12C蛋白抑制剂GFH925已于2024年8月获批。 然而，在对招股书等资料进行梳理后发现，公司仍存在诸多隐忧。首先，KRAS G12C抑制剂市场竞争 日益激烈，已上市同靶点同适应症竞品销量惨淡，且国内已有两款同一适应症的竞品上市，另有多款处 于临床后期的在研管线，商业化前景难言乐观。其次，GFH925五个专利族申请仅一个获授权，国内外 市场均或面临专利风险，而公司删除前次招股书中的风险提示或为"欲盖弥彰"。此外，公司创收依赖于 对外授权，而与信达生物的合作协议已然生变，需向其退还2千万美元，使公司本就吃紧的资金情况进 ...

Core Viewpoint - Jinfang Pharmaceutical Technology (Shanghai) Co., Ltd. has submitted its listing application to the Hong Kong Stock Exchange, with CITIC Securities as the sole sponsor [1] Company Overview - Jinfang Pharmaceutical is a biopharmaceutical company focused on developing new treatment solutions for oncology, autoimmune, and inflammatory diseases [4][6] - The company has established a product pipeline consisting of eight candidate drugs, five of which are in clinical development [4] Key Products - GFH925 (fulzerasib), a selective KRAS G12C inhibitor, has been commercially approved in China for treating advanced non-small cell lung cancer (NSCLC), making it the first of its kind in China and the third globally [4] - GFH375 is an oral small molecule inhibitor targeting KRAS G12D, with ongoing Phase I/II clinical trials in China for patients with advanced solid tumors carrying the KRAS G12D mutation [4][6] Research and Development - The company aims to diversify its product pipeline beyond RAS drug matrices, including GFS202A, a bispecific antibody targeting GDF15 and IL-6, and GFH312, a small molecule drug targeting RIPK1 [4][6] - R&D expenses for 2023 and 2024 are projected to be approximately RMB 313 million and RMB 332 million, accounting for 86.2% and 85.1% of total operating expenses, respectively [6] Financial Performance - Revenue for 2023 and 2024 is estimated at approximately RMB 73.73 million and RMB 105 million, with net losses of approximately RMB 508 million and RMB 678 million for the same periods [6][7] - The fluctuations in net losses are primarily attributed to significant investments in R&D activities and changes in the fair value of equity redemption liabilities due to the company's rising valuation [6]

聚焦肿瘤、自体免疫和炎症性疾病领域。 本文为IPO早知道原创 作者｜罗宾 2021年，劲方医药与信达生物（1801.HK）就GFH925达成授权交易，授予信达生物于大中华区开 发及商业化GFH925权益，以及在中国以外的全球地区开发及商业化此款产品的中国境外选择权。 2024年1月，双方签订GFH925补充协议，终止上述协议中的中国境外选择权。 劲方正在推进GFH925的海外临床开发，包括在EMA监管区域内国家进行与cetuximab（一款靶向 EGFR的抗体药物）联用作为一线治疗晚期NSCLC的联合疗法的Ib/II期临床试验。公司认为此款联 合疗法有望在抑制EGFR-RAS通路方面实现协同效应。 劲方医药另一款核心产品GFH312为劲方医药自主研发的高效小分子抑制剂，能针对受体相互作用的 丝氨酸/苏氨酸蛋白激酶1（RIPK1）并抑制其激酶活性， GFH312已获得FDA关于在美国开展第II 期临床试验的IND批准 ，以评估GFH312对外周动脉疾病（PAD）伴间歇性跛行（IC）患者的安全 性和疗效。与全球其他临床阶段的RIPK1抑制剂相比，劲方医药聚焦 GFH312的差异化临床计划， 针对一些可能严重影响患 ...