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新股消息丨康蒂尼药业第三次递表港交所 其大部分收益来自艾思瑞的销售

News of new shares, Contini Pharmaceutical Co., Ltd. submitted for the third time that the Hong Kong Stock Exchange derives most of its revenue from sales of Esri.

智通財經 ·  Feb 28, 2022 21:00

According to the Hong Kong Stock Exchange, Beijing Contini Pharmaceutical Co., Ltd. submitted its listing application to the main board of the Hong Kong Stock Exchange for the third time, with China International Capital Corporation as its exclusive sponsor, Zhitong Financial APP learned. It is reported that the company submitted two prospectuses on the Hong Kong Stock Exchange on April 8, 2019 and November 1, 2019, which have now lapsed.

Contini Pharmaceutical is a leading commercial biomedical company specializing in the research, development and commercialization of innovative drugs for organ fibrosis for 20 years. For a long time, it has been focused on idiopathic pulmonary fibrosis (IPF), and gradually expanded the field of treatment and R & D activities to other organ fibrosis areas. The company's flagship product, Pirfenidone, was approved in China in 2011 and was one of the first three drugs approved to treat IPF in the world. Since then, a drug pipeline containing four other innovative drug candidates has been developed and eight years of successful commercial experience has been accumulated. The rich pipeline and the revenue of RMB 437 million recorded by Aisirui in 2020 make the company a global leader in the treatment of organ fibrosis.

As the first drug approved for the treatment of IPF in China, Aisirui filled the gap in the treatment of IPF in China, quickly occupied the market, and was included in the national health insurance drug catalogue (national health insurance catalogue) since 2017. According to Frost Sullivan, the market size of IPF treatment in China is 478 million yuan in 2020, and it is expected that the IPF market will further increase to 3.853 billion yuan by 2031. In addition, because different organ fibrosis diseases have similar pathogenic mechanisms and fibrosis processes, the company is extending Esri's indications to other pulmonary fibrosis diseases (such as systemic sclerosis-related interstitial lung disease (SSc-ILD), dermatomyositis-associated interstitial lung disease (DMILD) and pneumoconiosis) and diseases that cause renal fibrosis (such as diabetic nephropathy (DKD)). According to Frost Sullivan, if these extended indications are approved, the total number of target patients in China will reach 9.7 million by 2031.

Liver fibrosis is another focus area of the company, and the company's key product in this area, F351 (hydroxynidone), is expected to open a new chapter in the company's development. F351 is currently in phase III clinical trials and is expected to be the first drug approved in the world to treat liver fibrosis associated with chronic hepatitis B (CHB). According to Frost Sullivan, the number of patients with liver fibrosis in China reached 139 million in 2020, of which about 46.7% (or 64.7 million) were caused by CHB. At present, there is no specific drug for the treatment of liver fibrosis in the world, and F351 is the fastest-growing anti-fibrosis drug in China and the world. Its phase II clinical trials clearly show that F351 has a significant effect in reversing the process of liver fibrosis. Because of its excellent efficacy and good safety, F351 was included as a breakthrough drug by the Drug Review Center in March 2021, and patients in phase III clinical trials began to be enrolled in January 2022. The NDA approval of F351 for the treatment of CHB-related liver fibrosis is expected to be obtained in the fourth quarter of 2024.

The company also has a broad product line to other indications, including for chronic obstructive pulmonary disease (COPD), pulmonary hypertension (PAH) and acute chronic plus acute liver failure.

The company has two production centers in Beijing and Cangzhou. Beijing preparation production Center, which was established in 2004, covers an area of 20056 square meters and has four preparation production lines with an annual production capacity of 200 million capsules. It has been approved to expand the design capacity to 1.4 billion capsules in 2021. Cangzhou active Drug ingredients (API) production Center covers an area of 46503 square meters and has an annual production capacity of 10 tons of APIs. It has been approved for transformation and construction in 2021, and the designed annual production capacity will be expanded to 50 tons of APIs. The company has also built a professional sales team and a sound sales network in the process of Avery's commercialization. As of the last feasible date, the company's sales and marketing team is composed of 297 members with an average working life of 9 years.

The company has always persisted in investing resources to carry out continuous research and development in order to lay the foundation for long-term growth. For the years ended December 31, 2019 and 2020, and for the nine months ended September 30, 2021, the company's R & D expenses and capitalization expenses deducted from profit and loss were RMB 20.4 million, RMB 100 million and RMB 66.7 million respectively, accounting for 6.3%, 22.4% and 15.1% of the company's earnings in each period, respectively. The company has a dedicated internal R & D team composed of 73 members. The company's R & D departments include drug discovery, CMC, clinical development, medical affairs and regulatory matters.

The company works with CRO partners to develop and produce some drug candidates for preclinical and clinical trials. In 2019, 2020 and the nine months ended September 30, 2021, the company cooperated with three, eight and eleven CRO (all located in China). The company also works with CRO, which conducts phase III clinical trials of F351. To conduct clinical trials of drug candidates in 2019, 2020 and the nine months ended September 30, 2021, the company worked with 42, 37 and 40 key researchers, respectively.

The company is also one of the few innovative biomedical companies that can achieve sustainable growth in China. The company's total income and net profit in 2019 were RMB 325 million and RMB 70.12 million, and increased to RMB 447 million and RMB 128 million in 2020, with growth rates of 37.5% and 82.5% respectively. The total income and net profit for the nine months ended September 30, 2020 were RMB 332 million and RMB 107 million, and increased to RMB 440 million and RMB 126 million for the nine months ended September 30, 2021, up 32.7% and 17.3% respectively.

During the track record period, most of the company's revenue came from Avery's sales. Specifically, in 2019, 2020 and the nine months ended September 30, 2021, the sales revenue of Aisirui was 315 million yuan, 437 million yuan and 432 million yuan respectively, accounting for about 96.8%, 97.7% and 98.2% of the total revenue in the same year.

The translation is provided by third-party software.


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