Autoimmune diseases are growing rapidly worldwide, giving rise to blockbuster drugs such as Humira.
However, in China, these diseases are not directly life-threatening, but only affect the quality of life and have been neglected for a long time. However, with the increase in income levels and the increase in concerns about health and quality of life, autoimmune diseases have begun to receive more and more attention. China's self-exempt market will usher in an explosive period.
Recently, JiangsuQuanxin BiotechPharmaceutical shares*** passed the hearing of the Hong Kong Stock Exchange and will be listed on the main board of the Stock Exchange in the near future. It became another 18A company focusing on autoimmune diseases after Keynaugh.
Quanxin's financial situation shows that the company's need for IPO financing is particularly urgent. As of the end of September 2023, the total cash and cash equivalents on the books of Quanxin Biotech were only 25.7 billion yuan, and in the first nine months of 2023, the company's operating cash outflow has reached 25.2 billion yuan.
This indicates that the company's current cash reserves are no longer sufficient to sustain one-year operating needs.
As a company focusing on the research and development of autoimmune products, Quanxin Biotech has 9 products under development, and many products have entered the clinical stage.
Clinical trials of self-immunized products typically require larger participants and are costly. Taking Quanxin's representative product IL-4R as an example, the product targets more than 7 indications, all of which are in the clinical stage or have obtained clinical trial approval, indicating that the company's future funding needs will further increase.
Listing and financing is one of the important ways to alleviate the financial pressure of Quanxin Biotech. Given that the company expects the earliest commercial product QX001S to be introduced to market in the fourth quarter of 2024, the financing of Quanxin Biopharma in 2024 before achieving self-hematopoiesis is particularly critical.
This timeipoBefore, Quanxin Biotech has completedround of financing, the financing amount is exceeded100 million yuan
Qiu Jiwan, the founder of Quanxin Biotech, and Yu Guoan are acting in concert, and subject to Qiu Jiwan's decision, they hold a total of about 3359%。It is worth noting that Huadong Medicine (000963SZ) holds 1709% is the second largest shareholder of the company.
The relationship between Qiu Jiwan, the founder of Quanxin Biotechnology, and Huadong Medicine can be traced back to Jiuyuan Gene.
In 1993, Jiuyuan Gene was jointly established by Sino-US Huadong, a wholly-owned subsidiary of Huadong Medicine, Fushi Biotech, Yuyou Construction and other companies. Qiu Jiwan, the founder of Quanxin Biotech, worked at Jiuyuan Genomics from July 1993 to January 2004 and served as the director of the institute when he left the company.
For Quanxin Biotech, Huadong Medicine favors it. In 2020,China and the United States East China investment 3700 million yuan, becoming the second largest shareholder of Quanxin Biologics, this transaction has also become an important investment in the field of autoimmunity of Huadong Medicine in recent years.
In addition, Huadong Medicine also bought Quanxin BiologicsDomestic rights to ustekinumab biosimilars,It is expected to become the first ustekinumab biosimilar in China.
Quanxin Biopharma has also relied more heavily on Huadong Pharmaceutical's commercialization capabilities in this series of transactions.
QX001S is the first commercialized drug expected by Quanxin Biopharma and the first domestic ustekinumab biosimilar to be submitted for BLA in China.
In August 2023, the NMPA accepted the marketing application for QX001S for adult moderate to severe plaque psoriasis, which is expected to be the first approved ustekinumab biosimilar in China. The company is expected to be the first to be listed in China in the fourth quarter of 2024.
In August 2020, Quanxin Biologics and Huadong Medicine entered into a cooperative development and commercialization agreement for QX001S in Chinese mainlandThe total upfront payment and milestone payment received by Quanxin Biotech is 50 million yuan, and in the future, it will obtain half of the domestic pre-tax profit of the product in the form of shares
The original drug of QX001S, Johnson & Johnson's ustekinumab, will have annual sales of US$10.8 billion in 2023, a year-on-year increase of 11%, becoming another US$10 billion autoimmune product after the drug king Humira.
The introduction of QX001S will strengthen Huadong Medicine's product portfolio in the field of ** medicine, especially in diseases such as psoriasis and atopic dermatitis. With the strategy of self-research and introduction, Huadong Medicine has accumulated a variety of first-class topical drugs, covering the needs of different disease severities. The addition of QX001S is expected to form a high degree of synergy with existing products and become a key part of Huadong Medicine's Pico strategy.
However, the competition for domestic biosimilars will be more intense than that of innovative drugs, and the company itself has warned of risks in its prospectus, believing that QX001S will face commercial competition in the domestic market with at least two other similar drugs with similar progress.
Despite the fierce competition from similar biosimilars, Huadong Medicine's commercialization capabilities are expected to provide strong sales support to Quanxin Biopharma.
As the marketing authorization holder of QX001s in China, Sino and US Huadong will be responsible for the exclusive marketing activities and commercialization of the product. The CMC subsidiary of Quanxin Biotech, Jiangsu Saphos, will be solely responsible for the commercial production of the product in China, which is calculated on a cost-plus 25% basis
With the listing of QX001S, Quanxin Biotech is expected to usher in its first operating cash flow, marking the beginning of the company's self-hematopoietic ability of operating activities.
Quanxin's core product, QX005N, a monoclonal antibody against IL-4R, has obtained IND approval for 7 indications, making it the IL-4R antibody drug with the most IND licenses in China.
Especially in **Atopic dermatitis(ad) andPrurigo nodosum(PN), QX005N is about to start phase III clinical trials in China. The AD market has huge potential and has become the focus of competition among many pharmaceutical companies. Quanxin Biotech is the only company in China that conducts clinical trials of biologics in the PN patient population, demonstrating its differentiated strategic layout.
On January 31, 2024, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) listed QX005N as a breakthrough product for moderate to severe PN, becoming one of the few products in the field of autoimmunity that has received breakthrough recognition.
According to Frost & Sullivan, in 2022, the number of PN patients in China was about 2 million, and it is expected to reach about 2.1 million by 2030. At present, the development of China's PN drug market is still in its early stages, as of October 2023DupilumabIt is the only biologic agent approved by FDA and NMPA for **PN in China.
In terms of biologic drug candidates, onlyQX005N from Quanxin BiotechwithBA2101 from Boan BiotechBoth are in the clinical stage, and both are IL-4R inhibitors.
However, at the same time, he bought Quanxin BiotechThymic stromal lymphopoietintslp) monoclonal antibody rights and interests in ChinaHealth Meta,but chose a competitorBoan Bio'sIL-4R inhibitors, exclusive rights in Chinese mainland for respiratory diseases such as asthma and COPD. The reason why HealthSense did not choose Quanxin Biologics IL-4R productsWall Street Insight and Wisdom ResearchIt is thought that it may be related to product differentiation. In addition, QX002N is also a product that the company is optimistic about. It is a high-affinity monoclonal antibody targeting IL-17A, and Quanxin Biosciences has received IND approval for QX002N for ankylosing spondylitis and lupus nephritis, and plans to prioritize the development of QX002N for the indication of ankylosing spondylitis.
The clinical needs in the field of autoimmunity are extensive and unmet, showing the potential for rapid growth. With the further development of the self-exempt market, the competition of differentiated products will become the key.
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