In the era of double resistance in the field of self-immunity, Canoa (02162) becomes the leader of the next generation of self-immune drug kings.

Since the beginning of this year, the trading of innovative drugs in the market has been hot. According to Pharmaceutical Magic Cubes, in the first half of 2025, the total amount of licenses for innovative drugs in China reached nearly 66 billion US dollars, surpassing the total trading volume of 2024. The immune system drug market is the second largest prescription drug market in the world, second only to oncology. The proportion of BD is increasing, from 2023 to 2024, the proportion of oncology pipeline authorization transactions decreased from 72% to 61%, while the proportion of metabolism and autoimmunity increased from 12% to 25%. So, as the world's second largest prescription drug market, can immune drugs be the next IO? The field of autoimmunity is entering the era of dual targeting, and the next big hit may be born Autoimmune diseases are diseases caused by the body's immune system mistakenly attacking healthy tissues, usually with a long course and recurring symptoms, hence also known as "undeath cancer." These diseases generally do not directly threaten life, but often significantly affect the quality of life for patients. Although there are currently some treatment options available to alleviate symptoms, there is a lack of definitive cure methods. Especially for common autoimmune diseases such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA), the demand for medication and the need for continuous treatment are significant. Therefore, the field of autoimmunity has become a focal point in the pharmaceutical industry due to its huge market demand and unmet treatment needs. Business Research Insights estimates that the global autoimmune disease treatment market will reach 119.35 billion US dollars by 2027. Once upon a time, the immunotherapy market also gave birth to blockbuster drugs that sold over a billion dollars. Since the launch of the product in 2003, AbbVie's TNF inhibitor Humira (adalimumab) has been a worthy leader in the field of immunotherapy, surpassing two TNF products, Enbrel (etanercept, marketed by Amgen/Pfizer) and Remicade (infliximab, marketed by Janssen/ Merck) which were launched in 1998, and many other biologics. Until the expiration of the patent in January 2023, Humira contributed over 200 billion US dollars in revenue over a period of 20 years, obtaining approval for approximately 16 indications. The TNF inhibitor biologic market, the three main patented drugs' highest annual sales reached nearly 35 billion US dollars, it can be considered the most successful target in the history of innovative drugs. The immunotherapy drug market started with TNF inhibitors, attracting more developers to invest in the mechanism and market exploration of these types of diseases. After the above three blockbuster drugs, Belgium's UCB introduced Cimzia (certolizumab pegol) for Crohn's disease, and Johnson & Johnson continued to introduce another TNF inhibitor, Simponi (golimumab). However, whether it is UCB's Cimzia or J&J's Simponi, they have not been able to replicate the success of the three TNF inhibitors. Their sales are currently below 3 billion US dollars, and their peak sales have not exceeded 3.5 billion US dollars. After Humira, new targets in the field of immunotherapy have emerged (such as interleukins, JAK/Tyk2 inhibitors, etc.), and the number of patented drugs is much greater than during the TNF era, with single patented drugs having difficulty having indications exceeding 8. It shows that in the later stages of clinical and commercial competition, the market is becoming more heated, and the concept of precise treatment in clinical practice is gradually deepening. Currently, monoclonal antibodies have shown excellent efficacy in some autoimmune diseases, but some diseases such as COPD and IBD require better treatment methods. Therefore, research on bispecific antibody drugs for the treatment of autoimmune diseases is gradually emerging. The core feature of bispecific antibody drugs is the ability to simultaneously target two different antigens or epitopes, more effectively inhibiting disease progression, and can also be designed to simultaneously inhibit the overactivation of immune cells and promote the function of regulatory cells, precisely restoring immune tolerance; in addition, bispecific antibody drugs can also induce specific cell interactions, known as cell bridging. This "bridging" can directly "recruit" effector cells to target cells, achieve precise cell killing or regulation, and in the treatment of autoimmunity, recruit T cells to kill abnormally activated B cells, plasma cells, etc. Bispecific antibody drugs can simultaneously target two different antigens or epitopes, such as TL1A/TNF, TSLP/IL-13, IL-17A/IL-17F, producing cumulative or inhibitory effects, blocking multiple pathogenic pathways, and more effectively inhibiting disease progression. This dual action mechanism makes bispecific antibody drugs more comprehensive in intervening in the pathological processes of autoimmune diseases, thereby improving treatment efficacy; at the same time, T cell engagers (TCE) and other bispecific antibodies can play a bridging role, connecting T cells with abnormally activated B cells, achieving precise elimination of B cells. Roche's MabThera (CD3/CD20 bispecific antibody) clinical data shows that in patients with refractory SLE, a single high-dose treatment with CD3/CD20 bispecific antibody can clear peripheral blood B cells for over 200 days (in the high-dose group), significantly better than the effect of CD20 monoclonal antibodies (such as rituximab) for weeks to months. Therefore, in the field of immunotherapy, the bispecific antibody drug market also has great potential. As for chronic obstructive pulmonary disease (COPD), the traditional LAMA/LABA/ICS triple therapy mainly focuses on relieving symptoms but cannot reverse the decline in lung function. Monoclonal antibody targeted drugs (such as dupilumab, tezepelumab) act precisely on key cytokines, receptors, or immune cells in the cascade of COPD inflammation, significantly reducing the number of eosinophils, thus alleviating type 2 inflammation and improving long-term patient symptoms. Bispecific drugs, by inhibiting the start (TSLP) and downstream effects (IL-13) of inflammation, may more thoroughly control type 2 inflammation than single-target drugs (such as IL-4R monoclonal antibodies). In terms of competitive landscape, Kornoughya's CM512 has progressed the fastest and entered Phase II clinical trials by March 25 this year. In animal models of COPD and asthma, CM512 significantly reduced the pathological features such as airway inflammation, high mucus secretion, and tissue fibrosis. Particularly, its prominent effect on inhibiting eosinophil infiltration and Th2 inflammation. Currently, bispecific autoimmune drugs are still in the research and development stage for COPD and further clinical trials are needed to confirm their reliability and effectiveness. It is worth mentioning that a few days ago, Jiangsu Hengrui Pharmaceuticals' HRS-9821 (PDE3/4 inhibitor) and the rights to 11 other preclinical molecules outside Greater China were licensed to GSK for 5 billion US dollars up front and milestone payments totaling 12 billion US dollars, for a total transaction value of $125 billion. If bispecific autoimmune drugs succeed in the COPD field, then the field of immunotherapy may see the emergence of the next super blockbuster drug. Kornoughya: The key to whether the core drug CM310 can be included in medical insurance is crucial Currently, there are many pharmaceutical companies in China that are focusing on the field of autoimmunity, and Kornoughya can be said to be the "drug king" in this field. They have a high-potential pipeline in various areas such as IL-4R, CLDN18.2, CD3, among others. Among them, the core product Certolizumab (CM310) is the first domestically approved IL-4R antibody drug and has entered the commercialization stage. Although Kornoughya's CM310 has been commercialized, its performance was modest with sales revenue of only 43 million RMB in 2024. After deducting distributor discounts and price subsidies, the net sales were 36 million RMB. Kornoughya's CM310 is the first domestically approved biological product for several indications, namely chronic sinusitis with nasal polyps (CRSwNP) and seasonal allergic rhinitis (SAR). These are the only approved indications domestically, setting them apart from Sanofi's flagship drug Dupixent. The success of CM310 in SAR indication, with phase III clinical data published in the prestigious journal Nature Medicine in April 2025, marks the first phase III clinical research for SAR disease targeting IL-4R. For the SAR indication, CM310's direct competitor is Dupilumab. Since its launch, Dupilumab's prices have generally trended downward: when it was first launched in China in July 2020, the price of Dupilumab was as high as 6666 RMB per 300mg injection; after being included in the medical insurance catalog in March 2021, the price for the same specification dropped to 3160 RMB per injection; when the medical insurance was renewed in January 2023, the price for the same specification further decreased to 2780 RMB; on November 28th last year, Dupilumab successfully renewed its medical insurance, and the price was reduced to around 1508 RMB for the same specification. Due to its late approval, CM310 was unable to participate in last year's medical insurance negotiations. Before entering the medical insurance, the commercial price of CM310 for 300mg was 1659 RMB per injection. In comparison, in 2025, patients choosing Dupixent with medical insurance reimbursement paid only around 450 RMB out-of-pocket per injection, or about 900 RMB per month with the usual dosage of two injections. The cost of medication was much lower compared to Certolizumab. Thus, the year-end medical insurance negotiation is vital for Kornoughya. In addition, there are other companies in China such as Canide/Xianse Lede (CBP-201), Zhixiang Jintai, Maizi, Jiangsu Hengrui Pharmaceuticals (SHR-1819), Sunshine Guojian Pharmaceutical (SSGJ-611), and Kangfang (AK120), which are developing IL-4R targeting drugs in the field of AD, but currently, whether in terms of development progress or clinical efficacy, they are at a disadvantage compared to CM310. Lede Lede (CBP-201) has just submitted an application for market approval, and other IL-4R monoclonal antibodies are still in phase III trials. It is worth mentioning that whether it is chronic sinusitis with nasal polyps or seasonal allergic rhinitis, CM310 is the exclusive approved biological product in China. This gives CM310 a significant advantage over Sanofi's Dupixent in these indications, highlighting Kornoughya's focus on clinical development. In this regard, for the indication of AD, Kornoughya's CM310 currently has only one competitor, Dupilumab, in the market, and the market competition is favorable. If successful in the medical insurance negotiations by year-end for AD indications, CM310 is expected to achieve volume growth and bring good performance returns to Kornoughya. Additionally, in indications such as chronic sinusitis with nasal polyps and seasonal allergic rhinitis, CM310 will not face market competition in the short term. Furthermore, the development progress of its global leading anti-tumor ADC drug CMG901 is also in a leading position. Given the current trend of innovation drug BD in the domestic market, Kornoughya's revenue in 2024 was 4.28 billion RMB, with revenue from external licensing cooperation reaching 3.92 billion RMB, accounting for 91.6% of the total revenue. However, unlike most innovative drug Licenses out, Kornoughya uses the NewCo model, and the above transaction volume was completed within six months. Compared to traditional License out models, the NewCo model seems to be more favorable to domestic Biotech companies. From a model perspective, on the one hand, the NewCo model can provide cash flow support for innovative drug companies while MNCs rigorously control the introduction of assets, promoting the research and clinical research of the company's own potential pipeline; on the other hand, this model can also to some extent diversify risks for domestic pharmaceutical companies. Moreover, from previous primary market practices, a NewCo with a post-investment valuation of 100 million to 150 million US dollars corresponds to a financing amount ranging from 80 million US dollars to 100 million US dollars. After around 2-3 years of operation, the expected exit value can reach 1 to 1.5 billion US dollars. The acquisition price for pipelines with phase II clinical data typically hovers around 1 billion US dollars. Therefore, based on the above valuation path, Kornoughya's successful NewCo agreements four times in a row demonstrate its potential in the internationalization strategy under this model, which in turn brings continuous valuation premium to the company. In conclusion, the field of autoimmune diseases, with its enormous market demand and unmet treatment needs, has become a focal point in the pharmaceutical industry with tremendous development potential. Currently, the field has entered the era of bispecific antibodies, and the first bispecific autoimmune drug is expected to create a new breakthrough in the field of autoimmunity. As a leading company in the field of autoimmune diseases in China, Kornoughya occupies a leading position in the research and deployment of bispecific autoantibodies. If CM310 can smoothly pass the medical insurance negotiation by the end of the year, its only competitor is Dupilumab in the AD indication, presenting a good market competitive landscape and is expected to gain volume through medical insurance, bringing good financial benefits for Kornoughya. In indications such as chronic sinusitis with nasal polyps and seasonal allergic rhinitis, CM310 will not face market competition in the short term. Additionally, its global development progress in the anti-tumor ADC drug CMG901 is also in a leading position. With the background of the current trend of innovation drug BD in the domestic market, Kornoughya is advancing its internationalization strategy through the NewCo model. This layout is expected to open up further opportunities for market valuation growth for the company.