Kadmon Corp. LLC

2025年秋，一则关于AI制药新锐“华深智药”与跨国巨头赛诺菲达成BD合作的消息，在创投圈和医药界同时刷屏。这则新闻的主角，是华深智药的CEO——朱祯平博士。两年前，当他离开三生制药这家“老牌”药企，转而投身一家从零开始的AI制药公司时，业内不乏观望与质疑。而今，朱祯平用一份扎实的BD成绩单证明，他那套追逐前沿创新项目的顶尖能力，在一个全新的平台上依然奏效。一个顶尖职业经理人的价值，在于其无可替代的“可迁移能力”。而回溯朱祯平的职业生涯，最浓墨重彩的一笔，无疑是他亲手主导并缔造的——三生制药的“惊天一跃”。如今，他过去缔造的传奇有了新进展：2025年11月，在创纪录的14亿美元首付款入账近半年后，三生制药与辉瑞联合宣布了SSGJ-707的全球III期临床开发计划。双方将“Jumpstart（快速启动）”多项全球、多中心注册性临床试验，剑指NSCLC和CRC的一线治疗。这则消息的分量，丝毫不亚于半年前那笔“天价”BD。它在一定程度上也回答了中国创新药行业最迫切的问题：“BD之后，我们到底应该看什么？”百利天恒、康方生物、科伦博泰、信达生物，以及三生，这几家不断刷新中国BD交易纪录的创新药公司，如今都不约而同地跟着合作伙伴们一起在全球启动大规模三期临床。和国内临床试验“小打小闹”不一样的是，全球舞台上的大规模多中心临床，是一种“基于高确定性”的大手笔投入，成本要多一个数量级。用赚来（抑或是融来）的人民币资金，去做按美元计价的成本支出，这个看似不合理的投入，是中国创新药企真正走向世界的必经之路。而国内这批公司，有的选择全让海外合作伙伴投入，有的则选择躬身入局。而对于朱祯平的新公司、以及今年42个总价加起来超过476亿美元BD出去的创新分子来讲，这其中最后有多少能进入到新一轮的“全球开发计划”，大抵上也是对中国创新药2025年启动的这轮BD热潮的一次大考。朱祯平和三生制药，未来将走向何方，一定程度上也逃不开这个产业的历史发展洪流。关键先生、“丹生”败局与辉瑞“All-in”要理解三生的“一跃”，必须先理解它的“稳健”。与绝大多数Biotech不同，三生制药是一家手握充裕“老钱”的成熟企业。它依靠TPO（特比澳）和EPO（益比奥）两大重组蛋白产品，奠定了在肾科、血液领域的绝对龙头地位。仅特比澳一个品种，就在近十年（2014-2024）实现了收入十倍增长，市占率稳居第一。这份强大的“家底”——超80亿的在手现金和超20亿的经营性现金流——是公司抵御行业寒冬、逆周期布局的底气。同时，公司通过战略并购中信国健（获得自免大品种“益赛普”）和浙江万晟（获得消费医疗“蔓迪”），构建了多元化的“护城河”。这是一个“没走过弯路”的优等生，商业化能力极强（拥有近3000人的销售团队）。但也正因如此，市场一度担忧其“成熟期”的天花板。转型的“火种”亟需点燃。而点燃这个火种的“关键先生”，正是朱祯平博士。朱祯平的履历堪称完美：全球顶级的VEGF通路专家之一，重磅药物Cyramza（雷莫芦单抗）的操盘手之一。这份履历让他对PD-1/VEGF这个方向有着超前的“执念”。早在2014年，当朱博士还在Kadmon任职时，团队就萌生了开发PD-L1/VEGF双抗的想法。但可惜，因公司战略重心转移，再加上那几年IO单抗都还没火起来，就更没有双抗的地位了，因此即便2016年在AACR上进行墙报展示，也未获重视。2017年，加盟三生制药担任研发总裁后，朱祯平终于获得了将其“执念”付诸实施的平台和资源。虽然那几年，双抗仍停留在“TCE治疗血液瘤”那种“为了上市而上市”的阶段，但那几年，朱祯平已经在公开场合大力推荐各种作用机理的新型双抗落地应用了（）。而SSGJ-707，这款后来震惊业界的PD-1/VEGF双抗，也在三生制药的实验室里诞生。然而，这个“金蛋”的孵化之路并非一帆风顺，它甚至险些在黎明前被“贱卖”。时间来到2022年，全球生物医药资本寒冬凛冽。三生制药也试图效仿主流Biotech的资本运作，宣布将707等双抗资产“装入”一家新公司（Newco）——“丹生医药”，进行独立融资。当时，丹生医药获得了由奥博资本（OrbiMed）等顶尖VC领投的4000万美元A轮融资，但估值仅在1亿美元左右。回头来看，这无异于“白菜价”。戏剧性的一幕发生在2022年9月。三生制药一纸公告，宣布因“新冠疫情等因素影响”，这笔A轮融资交易意外终止。这个差点被“低价”剥离的“金蛋”，阴差阳错地回到了母公司三生制药的怀抱。这被后来者视为“因祸得福”——它完美避免了资产在低点被VC“赚走中间差价”的行业宿命（恒瑞TSLP单抗的案例）。资产回流母公司后，707的临床开发继续推进。但与此同时，老牌药企的创新转型似乎也伴随着必然的磨合阵痛。2023年，朱祯平博士离开了三生制药，加盟AI制药新锐华深智药担任CEO。关于他离开的原因，市场众说纷纭。有人猜测，这或许是MNC背景的职业经理人与本土老牌药企在管理文化、创新激励上的“水土不服”；亦有人认为，在经历了“丹生医药”融资的波折后，双方在核心资产的未来路径上可能产生了分歧。无论如何，朱祯平的离去，为707的故事增添了更多传奇色彩。因为，他亲手打造的“金蛋”，在他离开后，迎来了最耀眼的“顶峰时刻”。2025年ASCO年会前后，PD-1/VEGF赛道被彻底引爆——康方生物AK112的优异三期数据、BMS与BioNtech就BNT327达成的天价合作，让全球MNC的目光都聚焦于此。此时，三生制药公布了707的II期数据：在NSCLC一线治疗中，展现了高达64.7%的cORR，显露出“Best-in-Class”的惊人潜力。辉瑞果断“All-in”入局。他们不仅开出了创纪录的14亿美元首付款，后面又追加1.5亿美元买断了中国权益，并入股1亿美元。辉瑞第一时间召开投资者会议（Pflash），将707（PF-08634404）列为肿瘤管线的核心资产。这笔交易，成为了对朱祯平博士此前工作的最高“加冕”。BD 2.0的“下半场”，中国药企的全球“大考”朱祯平的离场，标志着707“上半场”（研发+BD）的结束；辉瑞的入局，则开启了“下半场”（全球临床+商业化）。这也清晰地回答了那个行业终极问题：拿到钱之后，我们到底看什么？BD不是终点，而是“入场券”。707项目已从三生的“研发考场”转移到辉瑞的“全球临床考场”。辉瑞在投资者会议上明确表示，将“Jumpstart（快速启动）”707的全球III期临床，覆盖NSCLC、CRC及多个瘤种。这正是“创新出海2.0”的核心命题。BD之后，市场的焦点在于“全球临床推进以及关键数据读出”。如今，越来越多的中国创新药企正集体迈入这片“深水区”：科伦博泰/默沙东的sac-TMT（TROP2 ADC），已累计开启14项全球3期临床。百利天恒/BMS的BL-B01D1（EGFR/HER3 ADC），已开启3项全球3期临床。康方生物/Summit的依沃西单抗（AK112）（PD-1/VEGF），已启动多项全球3期，HARMONi研究数据已读出。以及三生制药/辉瑞的SSGJ-707，也已开启2项全球3期临床。这些产品正集体进入全球注册性临床阶段。BD 2.0时代，不再是“一锤子买卖”，而是看中国资产能否真正通过全球III期临床的严苛考验。707拿到了巨额资金，但竞争才刚开始。在PD-1/VEGF这个最火热的赛道上，一场全球“三国杀”已经上演。707将正式在全球舞台上，与康方/Summit的AK112、BMS/BioNtech的BNT327进行“头对头”的直接竞争。未来的价值兑现，取决于谁的临床数据更优、适应症拓展更快、上市速度更胜一筹。一家真正的创新龙头不能只靠一个产品。市场在为707欢呼的同时，也在审视三生制药的“第二增长曲线”。这是三生“老牌药企”优势的体现：自免军团（Fast Follow）：IL-17（608）、IL-1β（613）、IL-4R（611）等多个产品已进入NDA或III期，预计2026年起密集获批，有望接力增长。引进资产（License-in）：引进的口服紫杉醇、HER2-ADC（DB-1303）、司美格鲁肽（减重）等，将充分利用其近3000人的强大商业化机器快速变现。“下一个BD？”：早期管线中布局的TL1A、BCDA2、IL33等热门靶点，已具备再次“出海”的潜力。而除了三生，对于更多的半只脚已经踏入全球制药Pharma位列的药企来说，怎么去围绕当下的核心资产，无论是借助BD还是自己开发，去深度参与到原本是全球MNC们专属的下一轮治疗地位竞争中去，也是中国这一批创新药的新时代命题。结语：三生制药的转型故事，是中国创新药行业老牌药企转型的一个缩影。它融合了“老钱”+“新研”+“资本戏剧”等所有关键要素，最终在行业周期底部完成了价值的“惊天一跃”。而707的“天价BD”不是毕业典礼，而是中国创新药企集体获得的全球生物制药“牌桌”的“入场券”。“BD 2.0”时代，“上半场”——证明中国有能力“孵化”并“卖出”60亿美金的故事——已经结束。“下半场”的核心，是证明中国有能力在全球舞台上“打赢”这个故事。市场正在屏息以待，等待的不仅是707的全球III期数据，更在等待科伦、康方、百利等先行者们的第一份全球“大考”成绩单。而这将最终决定谁能从“产品卖家”真正蜕变为“全球玩家”。延申阅读：投资丨产业分析丨故事丨观察欢迎点个喜欢并留言讨论，笔者尽可能认真回答

The European Medicine Agency's drug advisory panel recommended approval of Sanofi's immune thrombocytopenia (ITP) therapy Wayrilz (rilzabrutinib) and Insmed's lung disease drug Brinsupri (brensocatib) on Friday. However, the French pharma's experimental graft-versus-host disease (GvHD) treatment wasn't as lucky — the Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for Rezurock (belumosudil). The panel also voted to keep Pfizer's sickle cell therapy Oxbryta (voxelotor) off shelves. Two thumbs upWayrilz and Brinsupri are a step closer to European approval, just a few months after they were greenlit in the US. The FDA in August cleared Wayrilz — gained via Sanofi's $3.7-billion purchase of Principia Biopharma in 2020 — for adults with persistent or chronic ITP who have had an insufficient response to a previous treatment.In the Phase III LUNA 3 study, the oral BTK inhibitor met the primary endpoint of durable platelet response, with 23% of ITP patients who received the therapy achieving platelet counts at or above 50,000/μL for at least eight out of the last 12 weeks of the 24-week blinded treatment period in the absence of rescue therapy, compared with zero patients in the placebo group. Also in August, Brinsupri became the first drug approved in the US for non-cystic fibrosis bronchiectasis (NCFB), and it's poised to earn the same title in the EU.The DPP1 inhibitor met the pivotal ASPEN study's primary endpoint, with low- and high-dose Brinsupri achieving statistically significant 21.1% and 19.4% reductions in the annualised rate of pulmonary exacerbations, respectively. "With this positive CHMP opinion and the recent FDA approval of Brinsupri, we are witnessing the beginning of a new chapter for patients living with NCFB — a serious, chronic lung condition that has long lacked approved treatment options in the European Union," said Insmed Chief Medical Officer Martina Flammer.A pair of negative opinionsHowever, Sanofi's Rezurock failed to earn the CHMP's favour, with the panel concluding that "the benefits…did not outweigh its risks."The French pharma gained the oral ROCK2 inhibitor through its $1.9 billion buyout of Kadmon in 2021, shortly after the FDA approved it for GvHD.In the pivotal Phase II ROCKstar trial of 132 adults and adolescents with chronic GvHD who had received two to five prior lines of systemic therapy, Rezurock achieved an overall response rate of 75% through Cycle 7 Day 1 of treatment. The median duration of response, calculated from first response to progression, death or new systemic therapies for chronic GvHD, was 1.9 months. The CHMP said it struggled to quantify Rezurock's effect in patients who had tried other treatments, as ROCKstar didn't have a comparator arm. And while it considered recommending a conditional marketing authorisation, contingent on confirmatory data, Sanofi said it won't have additional efficacy data for Rezurock until April 2030. The drugmaker said in a release Friday that it will seek a re-examination of the CHMP opinion. "Sanofi is confident in the body of clinical and real-world evidence that underscores Rezurock's consistent efficacy and well-established safety profile for treating third-line chronic graft-versus-host disease. We will continue to work closely with the European Medicines Agency with the aim of bringing this treatment to patients in the EU who are waiting," said Olivier Charmeil, EVP, general medicines at Sanofi.The advisory committee also recommended against re-instating the approval of Pfizer's Oxbryta. The haemoglobin S polymerisation inhibitor was pulled from global markets last year, including the EU, following a number of deaths in clinical studies (see – Vital Signs: Global Blood in the water for Pfizer's dealmaking record book).Commenting on its opinion that Oxbryta's marketing authorisation remain suspended, the panel noted that recent clinical trials showed more sudden pain episodes and deaths."The CHMP found no clear explanation for the increased risks and could not identify measures to effectively minimise these risks or any subgroup of patients for whom the medicine’s benefits would outweigh its risks," the committee said. "As a result, the CHMP concluded that the benefit-risk balance of Oxbryta is no longer favourable."

After reviving an old Roche drug that’s now on its way to FDA approval for high blood pressure, Catherine Pearce and her team have set their sights on the next program they want to bring back from the basement of big pharmaceutical companies. Pearce and former colleagues from CinCor Pharma have started a new hub-and-spoke company called Juca Bio. And on Tuesday, Juca launched its first portfolio company, AllRock Bio, with $50 million and plans to develop an old Sanofi asset for pulmonary hypertension. Hub-and-spoke biotechs have become a way for a central company to spin out several smaller outfits that each work on specific drugs or areas. The theory is that “spoke” companies can benefit from the parent company — the “hub” — and its resources and leadership. And when it’s time to raise money for an asset or sell it, it creates a focused transaction that won’t uproot the rest of the business. Juca Bio’s goal is to take languishing assets from large pharma companies and develop them. “I would look at Juca as the engine of this development effort,” Pearce said. That was the model at CinRx Pharma, which Pearce co-founded. CinRx served as the hub, and CinCor, which she also founded, was a spoke that resuscitated the Roche drug baxdrostat. AstraZeneca in 2023 bought CinCor for up to $1.8 billion, and is now headed to the FDA for approval of the pill for high blood pressure. AllRock’s lead asset, as the company’s name suggests, is a pan-ROCK inhibitor. Sanofi acquired the drug in 2021 as part of a $1.9 billion deal with Kadmon. That older deal, however, was centered around Kadmon’s approved drug, Rezurock, a ROCK2 inhibitor for certain patients with chronic graft-versus-host disease. “Kadmon had a second drug sitting behind it, which is now ROC-101,” Pearce said. “It just didn’t fit [Sanofi’s] therapeutic strategy.” Now, that pan-ROCK inhibitor is in AllRock’s hands, and it’s planning to study ROC-101 in two indications: pulmonary arterial hypertension, or PAH, and pulmonary hypertension with ILD. AllRock is set to start Phase 2 studies later this year, bankrolled by its newly announced Series A that was led by Versant Ventures and Westlake BioPartners. In Phase 2, AllRock will study its candidate on top of standard treatments, including Merck’s Winrevair in PAH, which received FDA approval last year. ROCK inhibitors block rho kinases, which are proteins that play a role across many cell functions. Aside from Rezurock, two ROCK inhibitors are approved in the US or abroad for glaucoma and pressure in the eye. In pulmonary hypertension, there’s high blood pressure in the vessels between the heart and lungs. The pan-ROCK approach is expected to work not only by dilating the blood vessels, but also by cutting inflammation and scar tissue formation, according to AllRock CMO Bill Marshall, who also previously worked at CinCor. Pearce, Marshall, and CBO and co-founder Justin Thompson all serve as executives across both Juca and AllRock with the same titles at both companies. AllRock will share Phase 1 data at the European Respiratory Society meeting in Amsterdam later this month. Pearce said the key finding from that study was identifying a therapeutic dose level that was safe. “I think there was some hesitancy in developing a pan-ROCK. There was a perception that a pan-ROCK inhibitor would cause hypotension, and we did not see that,” she said.