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The investment in Fortvita, the market is highly concerned about the actions of innovative pharmaceutical companies, which is a supervisory force, which is also increasingly normal for innovative pharmaceutical companies. At the same time, a good company should be able to stand up to and respect multiple opinions. So can a persuadable creature of faith still be trusted? After the emotion, the debate has calmed down, or to return to the main line of investment growth logic. Innovent Biologics is facing three key changes: break-even, the birth of pharmaceutical king, and internationalization, which means value enhancement. After the PD-1 encountered obstacles at sea, Innovent Biologics had a deep sense of crisis, and pursued efficiency and fine management through a low-key bottom-up route, and miraculously supported a huge R&D pipeline with robust R&D expenditure. The product revenue of Innovent Biologics 2024Q3 exceeded 2.3 billion yuan, an increase of 40% year-on-year and 15% quarter-on-quarter. In the last four quarters, product revenue has climbed continuously, which is better than expected, verifying the excellent strength of domestic commercialization capability. Unlike most Biotech companies, Cinda no longer only looks at the situation of a single product, but wins with a diversified product matrix, which is similar to the robustness of traditional pharmaceutical companies Hengrui Pharmaceutical and China Biopharmaceutical. According to IQVIA statistics, in 2024H1, the total patient share of listed PD-(L)1 in China was the first for Xinda Biobasu, with a total share of 56% together with Beigene Beizan, and the market pattern was still relatively concentrated. As a cornerstone drug for cancer treatment, PD-1 market share is crucial, representing the right of pharmaceutical companies to speak in the field of cancer drugs. Innovent Biologics has crossed the death valley of the life cycle of innovative pharmaceutical companies, is sprinting to the break-even line, 2024H1 loss convergence to 393 million yuan, 2025 is expected to achieve adjusted EBITDA breakeven. This is all based on endogenous product revenue, rather than transient external BD licensing revenue. Cinda Bio-Mastal peptide is the world's first GLP-1R/GCGR dual-target agonist in the NDA stage, with NDA applications submitted in January 2024 for weight loss indications and NDA applications submitted in August 2024 for Type II diabetes indications, and both indications are expected to be approved for marketing in the first half of 2025 at the earliest. Compared with competing products (Simeaglutide, Tipotide), Maaldotide has a strong weight loss effect, and the 9mg group achieved a better weight loss benefit of 18.6% at 48 weeks when the average BMI and average body weight were higher at baseline. In addition to weight loss, Masidin is more worthy of expectation in terms of comprehensive metabolic benefits. The improvement of fatty liver was more obvious, activated liver GCGR, promoted fatty acid oxidation and lipopolysis, and the phase III clinical results showed that the liver fat content decreased by 80.2%, which was better than GLP-1R single agonist and other double-target agonists. Cinda has proven its commercialization efficiency, and Masaldopeptide as a super drug is about to explode the market. In the field of cardiovascular metabolism, there are high-potential products such as Symbila (PCSK9), which was approved for market last year, and Tetuzumab for thyroid ophthalmopathy, which is expected to be approved next year. Ophthalmology, free of large products are expected to be approved within 1-2 years. Tetuzumab (IGF-1R) was accepted as the NDA for the treatment of thyroid eye disease in May 2024, which is the first IGF-1R antibody to be declared for market in China, which will be a breakthrough variety exclusive to Cinda in this field; Piconcibezumab (IL-23p19) in the treatment of plaque psoriasis has potential better efficacy and advantages of long interval administration, and has been submitted for application. IBI302 is the world's first VEGF/ complement dual-target molecule in the treatment of stage 3 age-related macular degeneration. In recent years, we have also seen that Innovent Biologics is preparing for internationalization. The first is the layout of a new generation of innovative technology and self-research pipeline, involving ADC, double antibody, multi-antibody, small nucleic acid, in the first half of this year, self-developed varieties IBI343 (CLDN18.2 ADC) and IBI363 (PD-1/IL-2) disclosed preliminary clinical phase I data, showing positive early clinical signals. Secondly, the company invests more resources to simultaneously carry out overseas early clinical research and expand overseas research and development teams. It can be seen that the company attaches great importance and prudence to internationalization. From the appearance of the sea platform Fortvita, the company is still in a very early stage, the risk is extremely high, most of them are pre-clinical research and development projects, there is no pipeline assets to reach overseas POC, the layout is related to antibodies, involving tumor, non-tumor fields, similar to listed companies. It does not yet have production and sales functions. We seem to see that the muscle memory of the last failure is still dull, and Cinda Biology is extremely cautious about the first step of internationalization. Fortvita's current situation and direction are unclear, which precisely shows that internationalization is still in the exploratory stage. It is not ruled out to open other channels or ways to go to sea, License-out, NewCo model, cooperative development are all potential options, everything is full of variables. It is in the midst of uncertainty that management is prepared to demonstrate its commitment to internationalisation with real money, and that the market is too quick to judge the ethics of management. Even if the deal is withdrawn now, Fortvita's independent sea is still a proposition that Xinda and shareholders need to solve jointly. In any case, the internationalization of Innovent Biologics is also like an arrow from the string, there is no turning back, and it will eventually be achieved. China's new drugs are trekking a difficult road, fortunately has run out of a small number of leading companies, the fate is not tied to a clinical trial or business progress. Compared with the broad fundamentals of Xinda, this controversial event is just a small floating cloud, which will not shake the value of Innovent Biologics.

信达生物准备补齐最后一块短板。 信达生物是国内创新药企效率之王，运营能力、临床速度都得到充分验证。 然而，国际化意难平。对股价近两年徘徊在40元左右的信达生物而言，任何出海成功都是增量。 10月25日晚，Fortvita作为信达生物推动国际业务的平台正式亮相。随着地缘政治环境越来越严峻，发展Fortvita是信达生物在BD暂无进展、PD-1闯关失败之后的一个较好选择。管理层愿意深度绑定、愿意注资，也是有决心做好国际化。 但此事却引发各方热议，成为本周热点。 今日，信达生物公告经审慎考虑市场意见，撤回管理层对Fortvita的投资。 市场高度关注创新药企动作，是一种监督力量，这对于创新药公司来说也越来越常态化。同时，好公司也应当经得起并尊重多方意见。 那么，听劝的信达生物还值得信任吗？ 情绪过后，争论平息，还是要回归投资的成长逻辑主线。 信达生物正面临三个关键转变：盈亏平衡、药王诞生、国际化发力，这些都意味着价值提升。 盈亏平衡 信达生物在PD-1出海遇阻之后，深具危机感，通过自下而上的低调路线，追求效率和精细化管理，以稳健的研发支出，奇迹般支撑起庞大的研发管线。 信达生物2024Q3产品收入超23亿元，同比增长40%，环比增长15%。最近4个季度产品收入连续爬坡，好于预期，验证国内商业化能力的优秀实力。与大部分Biotech不同，信达目前不再只看单品情况，而是以多样化的产品矩阵取胜，在稳健程度上类似于传统药企恒瑞医药、中国生物制药。 据IQVIA统计，2024H1，中国已上市PD-(L)1总体患者份额第一位为信达生物达伯舒，与百济神州百泽安一起合计份额达56%，市场格局仍相对集中。作为肿瘤治疗的基石药物，PD-1市场份额至关重要，代表着药企在肿瘤药物领域的话语权。 信达生物已跨过创新药企生命周期的死亡谷，正冲刺盈亏平衡线，2024H1亏损收敛到3.93亿元，2025年有望实现经调整EBITDA盈亏平衡。这全靠内生的产品收入，而不是一过性的对外BD授权收入。 药王诞生 未来全球及国产药王从GLP-1药物中产生已经没有悬念。 信达生物玛仕度肽是全球首个处于NDA阶段的GLP-1R/GCGR双靶点激动剂，减重适应症于2024年1月递交NDA申请，II型糖尿病适应症于2024年8月递交NDA申请，两项适应症最快有望于2025年上半年获批上市。 与竞品（司美格鲁肽，替尔泊肽）相比，玛仕度肽具有强劲的减重疗效，9mg组在平均BMI与平均体重基线更高的条件下，48周体重降低18.6%，获得更优的减重收益。 减重之外，玛仕度肽在代谢综合获益方面更值得期待。改善脂肪肝更明显，激活肝脏GCGR，促进脂肪酸氧化和脂肪分解，III期临床结果显示，肝脏脂肪含量降幅80.2%，优于GLP-1R单激动剂和其他双靶激动剂。 信达已验证自己的商业化效率，玛仕度肽作为超级药物，即将引爆市场。心血管代谢领域还有去年获批上市的信必乐（PCSK9）和明年预计获批的甲状腺凸眼病的替妥尤单抗等高潜力产品形成组合拳优势。 眼科、自免均有大产品预计1-2年内获批。替妥尤单抗（IGF-1R）于2024年5月治疗甲状腺眼病NDA获受理，是中国首个申报上市的IGF-1R抗体，这将是一个信达在该领域独家的突破性品种；匹康奇拜单抗（IL-23p19）治疗斑块状银屑病，具有潜在更佳疗效及长间隔给药优势，已提交上申请；IBI302是全球首个VEGF/补体双靶点分子，治疗年龄相关性黄斑变性三期进行中。 国际化继续 打开更高天花板还得出海。 这几年也看到信达生物在为国际化蓄势。首先是布局新一代创新技术和自研管线，涉及ADC、双抗、多抗、小核酸，今年上半年，自研品种IBI343（CLDN18.2 ADC）和IBI363（PD-1/IL-2）披露临床I期的初步数据，显露积极的临床早期信号。其次，公司投入更多资源，同步开展海外早期临床研究和扩建海外研发团队。可以看出公司对国际化的重视和慎重。 从出海平台Fortvita的亮相来看，这家公司还处于非常早期的阶段，风险极高，绝大部分为临床前研发项目，目前没有一个管线资产达到海外POC，布局与抗体相关，涉及肿瘤、非肿瘤领域，与上市公司相似。尚不具备生产、销售功能。 我们仿佛看见上次失败的肌肉记忆还在隐隐作痛，信达生物对发力国际化第一步极为谨慎。Fortvita的现状和走向不明朗，恰恰说明国际化还处于探索阶段。还不排除开启其他出海通路或方式，License-out、NewCo模式、合作开发都是潜在选项，一切都充满变数。 正是在不确定性中，管理层准备用真金白银来表明支持国际化的决心，市场急于对管理层的道德水平下定论，其实为时过早。即使现在交易撤销，Fortvita独立出海仍是信达及股东需要共同解决的命题。 无论如何，信达生物的国际化亦如离弦之箭，没有回头路，终要达成。 中国创新药正在跋涉一条艰难之路，所幸已经跑出少数头部企业，命运并不系于某一项临床试验或业务进展。信达本次争议事件相比宽广的基本面，只是渺小的浮云，不会动摇信达生物的价值主线。