On November 21st, Cornell Bio announced IL-4R α 52 week clinical data on the treatment of moderate to severe atopic dermatitis with monoclonal antibody drug Rademikabart.
According to the official website of Cornell Biology, this is the second phase of the Chinese trial for the development of this new drug, which means that Rademikabart continues the patient improvement observed in the 16th week of the first phase; Moreover, patient improvement occurs in both biweekly and weekly dosing regimens. Among them, the frequency of administration every four weeks is lower than that of currently approved therapies, which reflects the potential of the drug.
On the same day, with the release of key clinical progress information, Kangnaide Biotechnology also granted Rademikabart's Greater China rights exclusively to Xiansheng Pharmaceutical. The advance payment for this cooperation is approximately 150 million yuan, with milestone payments up to 875 million yuan.
Moreover, according to the agreement, Xiansheng Pharmaceutical will not only be responsible for Rademikabart's new drug application for atopic dermatitis indications in China, but also for Rademikabart's future clinical research and expenses for all other disease indications in the Greater China region. This also means that Cornell Bio has transferred most of the rights of Rademikabart located in Greater China to Xiansheng Pharmaceutical, while retaining the right to develop and commercialize this product in other markets.
On the secondary market, the stock price of Conrad Biotech fell by over 38% on November 21, with a closing price of $1.26/share and the latest market value of $69.39 million. During the period from July to October this year, the stock price of Conrad Biotech has dropped below $1 per share, almost on the brink of delisting.
Conrad Biotech was listed on NASDAQ in March 2021. This company was founded by Pan Wubin and his scientist friend Zheng Wei in Taicang, Jiangsu in 2012. The main challenge for enterprises in the field of diseases is focused on autoimmune diseases and inflammation treatment.
Rademikabart, also known as the once highly anticipated CBP-201 project. This drug targets IL-4R α (IL-4R α A whole human monoclonal antibody that is a common subunit of IL-4 receptors and IL-13 receptors. From the perspective of drug principles, Rademikabart and IL-4R α After combination, attempts can be made to block the functions of IL-4 and IL-13, thereby blocking the Th2 type inflammatory pathway and achieving the goal of treating a series of Th2 related inflammatory diseases such as atopic dermatitis and asthma. Therefore, in addition to atopic dermatitis, another focus of this drug is the treatment of asthma.
The reason why it was once highly anticipated is that there is currently only one approved IL-4R globally α Targeted drug, also known as Duprizumab, jointly developed by Sanofi and Regenerated Element. In history, on March 28, 2017, Duprizumab received the first approval from the US Food and Drug Administration for the treatment of adult patients with moderate to severe atopic dermatitis. According to Sanofi's semi annual report, global sales of Duprizumab in the first half of this year reached 4.878 billion euros, approximately 5.366 billion US dollars.
It is worth noting that on November 17th, Sanofi announced that Duprizumab was approved in China for maintenance treatment in adolescents and adults aged 12 and above with asthma. This also means that as of now, the approved indications for Duprizumab in China have covered both atopic dermatitis and asthma, and the indications for atopic dermatitis also enjoy medical insurance payments. This clearly increases the competitive pressure on Cornell Bio and Xiansheng Pharmaceutical in the domestic market.
At the beginning of its birth, Rademikabart was considered a heavyweight product that could potentially impact billions of dollars in products against the standard Prizumab. This also helped Conrad Bio attract a large amount of financing, including Qiming Venture Capital, which was once known as the "Taicang Unicorn". However, there has always been no evidence of superior efficacy from the biological aspect of Conrad.
On January 5, 2022, Cornell Bio disclosed detailed data from the Rademikabart experiment. The company believes that Rademikabart's 300mg treatment regimen is competitive. However, on January 5th and 6th of that year, the stock price of Conrad Bio plummeted for two consecutive days.
In addition, in addition to Rademikabart, a "star drug" that has now been handed over to Xiansheng Pharmaceutical, on May 3, 2022, Conrad Biotech announced that in another heavyweight product, the CBP-307 project, the main endpoint showed numerical improvement, but did not reach statistical significance. The company is preparing to authorize CBP-307 externally. This action is interpreted by the market as' selling children for survival '. Subsequently, on May 4th, the company's stock price fell by over 57%, closing at $0.82 per share, falling below $1.
According to the official website of Cornell Bio, in the company's current product pipeline, apart from the two focus products CBP-201 and CBP-307, only CBP-174 (small molecule, target not disclosed), CBP-233 (IL-33 monoclonal antibody), CBP-246 (antibody targeting IL-1RAcP), and CBP-403 (bispecific mAb targeting Th2 cytokines) have entered the clinical stage.
According to financial information, as of June 30 of this year, the cash, cash equivalents, and short-term investments of Kangnaide Biotechnology amounted to RMB 950.7 million, which was RMB 1127.3 million at the end of 2022. The company stated that the main reason for the decrease in this data is continuous research and development. Cornell Bio believes that according to its operating plan, it has sufficient cash and investment to support it until 2026.
In addition, as of the end of June this year, the administrative expenses of Cornell Bio have been reduced to RMB 56.2 million. During the same period, this data was 71.8 million RMB. As of the first half of this year, the company had a total net loss of RMB 212 million.
Currently, Cornell Bio also has Rademikabart conducting a global phase II trial on asthma indications. In the press release of China Daily, the company stated that it is expected to complete the trial, and the final visit of the last patient is expected to take place in October of this year. In June of this year, Conrad Biotech also released positive data on the maintenance period of the second phase clinical trial of CBP-307 in the treatment of moderate to severe ulcerative colitis until 48 weeks.