On April 25, Sanofi released its 2024 Q1 financial report. Of its total revenue of 10.464 billion euros, Dipriumab, the core product of the free free pipeline, contributed 2,835 billion euros, equivalent to 21.98 billion yuan. According to the annual report previously disclosed by Sanofi, the total global sales volume of the drug reached 11.5 billion US dollars in 2023.
This sales volume is clearly out of reach for the domestic IL4R monoclonal circuit Gemini Conoa-B (02162) and Concord Biotech (CNTB.US), which have yet to commercialize their products. However, after years of research and development, it seems that Connoah, one of the twins, will enter the commercialization stage this year, pointing to the global market for atopic dermatitis of over 20 billion US dollars. The certainty of commercialization is significantly greater than before.
Judging from the performance of the secondary market, since the intraday company's stock price reached a high of HK$82.85 on February 3 last year, Connoah's stock price has been fluctuating and declining for more than a year. On April 26 this year, it hit an intraday low of HK$26.60, and the biggest decline in the range reached 67.9%.
It is easy to see that Connoah's valuation on the eve of commercialization of the product has been drastically reduced. If Connoya wants to achieve a rebound in valuation, the subsequent approval timing and commercialization performance of Spuffizumab is worth paying attention to.
Can hematopoietic expectations raise estimates
Judging from the 2023 annual report disclosed by Conoah, Conoiaspuximab (CM310) has now achieved the NDA's acceptance of moderate to severe atopic dermatitis and chronic sinusitis with nasal polyps that have reached the main end point of phase III. In addition, the company recently announced successful phase III studies of this drug to treat seasonal allergic rhinitis. In other words, Connoya's core single product, spugibimab, has already entered the late clinical phase III/NDA stage with three indications.
In addition to this, another of Connoya's first ADC products targeting Claudin18.2, CMG901, has also entered the global phase III clinical application stage. However, in the first half of last year, Connoah and AstraZeneca reached an overseas licensing order of more than 1 billion US dollars for the drug, and received a down payment of 63 million US dollars as a result.
From a commercialization perspective, with the exception of the core product Spugibimab, Connoya's other pipeline products also have some potential for differentiated innovation, but their clinical progress has not yet reached the late stages, making it difficult to support the company's short-term hematopoietic expectations. From another perspective, Konoah's subsequent commercialization and valuation expectations can almost only depend on the performance of spugibimab in the three major indication markets.
According to the sales situation of priumab, although it has been approved for many indications around the world, atopic dermatitis indications are still a key area supporting its sales. This may also be true for the same target of spochibimab.
According to the Zhitong Finance App, judging from the domestic market, the number of patients with atopic dermatitis in China is quite large. In 2019, the number of AD patients in China reached 65.7 million. Statistics show that the number of AD patients in China reached 65.7 million in 2019, including about 47.5 million mild cases and 18.2 million moderately severe cases; it is expected that the number of AD patients in China will increase at a compound annual growth rate of 2.3% to 73.7 million in 2024, and increase to 81.7 million in 2030 at a compound annual growth rate of 1.7%. According to Anxin Securities's neutral assumption, the domestic market for moderate to severe atopic dermatitis is expected to reach 29.1 billion yuan by 2030.
For chronic sinusitis with nasal polyps (crSWnP), according to Frost & Sullivan data, the prevalence of crSwnP in China was 2010 million in 2021, and is expected to reach 23.1 million in 2030. In 2021, the size of China's CRSwnP drug market was US$131 million, and is expected to reach US$622 million in 2030, equivalent to RMB 4.505 billion, with a compound annual growth rate of 18.9%.
In the allergic rhinitis treatment market, the global market reached US$13.95 billion in 2020 and is expected to grow to US$17.86 billion in 2027; however, due to low penetration in the domestic market, the rhinitis medication market is estimated to be 4.4 billion yuan in 2024.
From the market space, it is easy to see that the future commercialization path of suprizumab may converge with dupliumab, that is, vigorously dig deeper into the market space for atopic dermatitis indications, but judging from market competition and commercial channel construction, it is currently unlikely that Connor will reach the big cake.
BIC in the commercialization stage is difficult to do
In recent years, Sanofi's research and development of products such as BTK inhibitors has failed, and the company itself is also laying off employees and slimming down, and its trend of betting on dupriumab is increasing. Therefore, as mentioned above, in the commercialization path of supivisumab, whether in the field of atopic dermatitis, sinusitis, or allergic rhinitis, this drug will never be able to bypass head-on competition with dupliumab.
Taking atopic dermatitis indications as an example, a previous phase III clinical results showed that after 16 weeks of treatment, the proportion of subjects who met the EASI75 standard was 66.9%, while the proportion of subjects who reached an IGA score of 0 or 1 and decreased by at least 2 points from the baseline was 44.2%. In comparison, in the phase 3 clinical trial of dapitol in China, the proportion of patients with EASI50 and EASI75 at week 16 was 71% and 57%, respectively, when treating atypical psoriasis. Although these data show the efficacy of dapitol, it is clearly at a disadvantage compared to supivisumab.
In addition, a previous phase III clinical result, which was mainly used to confirm the efficacy and safety of spiximab in the treatment of patients with chronic sinusitis with nasal polyps, also showed that although in the field of sinusitis, supivisumab and dupriumab were not head-to-head studies, in terms of efficacy and safety, both had significant efficacy in improving sinusitis patients. Recently, the phase III clinical trial of spiqibimab in terms of indications for allergic rhinitis revealed by Conoah also showed positive test data results. The main end points were fully met. Spugibimab was significantly superior to the placebo group, had highly significant statistical differences, and was safe.
The above data all show that there is no difference between the two in the field of clinical treatment, and even spugibimab has more BIC potential, but between R&D companies at the commercialization level, the real gap between the two may be in terms of sales performance.
The Zhitong Finance App learned that as the most successful target in the TH2 pathway field, regenerant/Sanofi's dupliumab has been approved for indications such as AD and asthma. After the success of chronic urticaria and COPD last year, Wall Street raised its future sales peak to nearly 20 billion US dollars, and sales reached 11.5 billion euros in 2023, accounting for large indications and continuing to expand indications along the way.
Furthermore, after only 5 months of domestic marketing, dupriumab was included in the national medical insurance catalogue, and became the only targeted biological agent for the treatment of moderate to severe atopic dermatitis in the new medical insurance catalogue. Currently, the medical insurance price for residents using 200mg of atopic dermatitis dabitum (dupriumab) is 1,631 yuan for two bottles.
From a production perspective, at present, Konoah has a production capacity of 18,600 liters to support the commercial production of spoximab. On the sales side, Connoah is also preparing to set up a commercial team of about 200 to 300 people by the end of 2024, but the size of this sales team is obviously difficult to compare with Sanofi. Furthermore, it is expected that supivisumab, which will be marketed in the second half of this year, will also be subject to dupriumab's medical insurance price card. Therefore, it is necessary to seize the opportunity to adjust the medical insurance catalogue at the end of this year before it is possible to compete with dupliumab on the hospital side.