Recently, Sinocell released its 2024 performance report, and the results are quite impressive.

In 2024, Sinocell's total operating revenue was 2.513 billion yuan, a year-on-year increase of 33.13%. Operating profit reached 568 million yuan, a year-on-year increase of 8829.33%, and the net profit attributable to the parent company's owners was 112 million yuan, successfully turning losses into profits. In addition, the non-net profit also reached 474 million yuan, also turning losses into profits.
1 2 billion single product

Sinocell is a leading innovative biopharmaceutical R&D and industrial development company founded by Dr. Xie Liangzhi, an internationally renowned biopharmaceutical expert.

The company was listed on the Science and Technology Innovation Board in 2020, and launched its first listed product, recombinant human coagulation factor VIII for injection (Anjiayin) in 2021. In 2024, the company finally turned losses into profits.

According to the announcement of Sinocell, the company's total operating income in 2024 increased by 33.13% over the previous period, mainly due to the increase in sales of the company's core product Anjiayin.

At present, Sinocell's listed products include 1 recombinant protein drug, 4 monoclonal antibody drugs, and 3 vaccine products have been included in emergency use. Among them, the recombinant protein drug SCT800 (Anjiayin) is the company's main source of income.

The drug is a third-generation recombinant coagulation factor VIII product and the first domestically produced recombinant coagulation factor VIII product approved for listing in China. Since its listing in 2021, it has rapidly occupied China's hemophilia treatment market. In 2023, the sales of Anjiayin reached 1.78 billion yuan, and it is expected to exceed 2 billion yuan in 2024. In addition, Sinocell is also expanding the overseas market of Anjiayin to provide incremental space for future revenue.

In addition, the sales of other listed products of Sinocell are also growing, including: CD20 monoclonal antibody Anpingxi, adalimumab biosimilar Anjiarun, bevacizumab biosimilar Anbezhu. At present, these three monoclonal antibodies have entered the national medical insurance catalog. It

is worth noting that in addition to the increase in revenue, Sinocell's profit growth is even more surprising. Its operating profit in 2024 increased by 8829.33% compared with the previous period, and its net profit also successfully turned losses into profits, reaching 112 million yuan.

In addition to benefiting from the stable growth of operating income, the company turned losses into profits. Sinocell also optimized the expense side. The company achieved cost reduction and efficiency improvement by actively controlling operating costs and improving R&D efficiency.

However, Sinocell explained that although the company's overall R&D investment has decreased compared with the same period last year, it still remains at a high level, and several products have been approved for clinical research. However, most of the existing pipeline products are still in the early clinical research stage, and the capital investment is relatively small. In terms of

the two potential explosive

products under development, Sinocell mainly focuses on the two major sectors of tumors and infections, and also has a few layouts in autoimmunity and ophthalmology.
Differentiated PD-1

In the field of tumors, earlier this month, Sinocell won a potential product: Fenolimab.

Fenolimab (trade name: Anyouping) is a PD-1 monoclonal antibody product independently developed and launched by Sinocell. It is approved for combination with platinum-containing chemotherapy for the first-line treatment of recurrent and/or metastatic head and neck squamous cell carcinoma.

Although the domestic PD-1 monoclonal antibody competition has become a red ocean, Fenolimab has found a differentiated positioning in indications. The incidence

of head and neck squamous cell carcinoma ranks sixth among systemic malignant tumors in China, and the mortality rate ranks seventh. Merck's K drug and BMS's O drug have both been approved for this indication at an earlier time. And Fenolimab is the first domestically produced PD-1 drug approved for the indication of head and neck squamous cell carcinoma.

According to a press release from Sinocell, Fenolimab has an outstanding performance in improving patient survival rates. The treatment regimen combined with 5-fluorouracil significantly improved patient survival, with a median overall survival (OS) of 14.1 months, while the placebo combined with 5-fluorouracil group was only 10.5 months, with a hazard ratio (HR) of 0.73.

With differentiated indications and excellent clinical data, Fenolimab is expected to occupy a place in the vast PD-1 market.

In addition, Sinocell has also deployed the potential product CD38 monoclonal antibody SCTC21C for hematological tumors in the field of tumors, as well as the differentiated CD3/CD20 dual antibody SCTB35 and PD-1/VEGF dual antibody SCTB14, all of which are currently undergoing Phase I clinical trials.

The best-selling vaccine

In the past few years, Sinocell has invested heavily in the development of new crown products and achieved good results. Its 2-valent variant recombinant S trimer protein vaccine SCTV01C (Annon), 4-valent (Alpha/Beta/Delta/Omicron variant) variant recombinant S trimer protein vaccine SCTV01E (Annon) and the improved iterative new crown vaccine SCTV01E-2 for variants BQ.1.1 and XBB.1 have been included in the emergency use of the state.

However, with the changes in the COVID-19 epidemic, the sales of these new crown vaccines are expected to be limited.

However, Sinocell's accumulation in the vaccine field may be rewarded in the HPV vaccine.

According to statistics, Merck's HPV vaccine Gardasil/Gardasil9 is the world's best-selling vaccine in 2024. In the Chinese market, although several domestic HPV vaccines have been approved for listing, most of them are concentrated in the low-priced field, and the nine-valent vaccine is still mainly imported from Merck.

The HPV vaccine being developed by Sinocell directly skipped the less competitive bivalent and quadrivalent vaccines, as well as the fiercely competitive nine-valent vaccines, and took the lead in deploying the fourteen-valent HPV vaccine (SCT1000).

Based on the existing nine-valent vaccine, the vaccine has added five new valent types (HPV35, 39, 51, 56, and 59), covering the 12 high-risk carcinogenic HPV virus types assessed by the World Health Organization and the two most important HPV virus types that cause genital warts. Compared with the 92% protection rate of the nine-valent HPV vaccine, the fourteen-valent HPV vaccine can theoretically increase the protection rate to 96%, making it more competitive in the market.

SCT1000 entered clinical research in 2021 and officially launched Phase III clinical trials in August 2023. It is the world's first 14-valent HPV vaccine to enter clinical trials. Its Phase I/II clinical data showed that the level of neutralizing antibodies induced by SCT1000 was significantly better than that of the existing nine-valent vaccine, and it had a higher potential for cross-protection against different types of HPV. SCT1000 has completed the third dose of Phase III clinical research and is currently in the follow-up stage.

However, the HPV vaccine market is changing rapidly. On the one hand, the reduced demand for Merck's HPV vaccine in China has led to a decline in its global sales, which may mean that the size of the HPV vaccine market has gradually peaked.

On the other hand, many domestic companies have already deployed HPV vaccines, and many nine-valent HPV vaccines are already in the late clinical stage.
However, in the field of high-priced vaccines, Sinocell's 14-valent HPV vaccine is at the forefront and is expected to submit an application for listing this year, seize the domestic high-priced vaccine market gap, and form differentiated competition with imported products.

Conclusion

Sinocell has successfully turned losses into profits through the sales volume of its core product, recombinant human coagulation factor VIII, and strict cost control. In terms of subsequent layout, PD-1 monoclonal antibody has been approved for listing, and the 14-valent HPV vaccine is also very promising. In addition, Sinocell is also promising in the field of bispecific antibodies (such as CD20×CD3 bispecific antibodies), and is expected to achieve international cooperation such as license-out, opening up incremental space in overseas markets.

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