In the 1950s, George W. Merck, then CEO of Merck, said a widely circulated saying in the pharmaceutical industry: "We should always remember that drugs are produced for humans, not for the pursuit of profits. As long as we stick to this belief, profits will follow." It is true. Looking at large overseas pharmaceutical companies, the key to their success lies in patient-centeredness and a strong sense of social responsibility. In China, there are more and more such examples. For example, the vision of Sinocell is to focus on the research and development of drugs urgently needed by the people and provide patients with high-quality and affordable biological drugs. It seems to coincide with Merck.

On the product side, Sinocell uses technological innovation to provide higher quality and lower cost drugs, which reduces the economic burden of domestic patients, while bringing better treatment effects and achieving a win-win situation of economic and social benefits. It is based on this business logic that Sinocell's performance has achieved sustained growth. In the first half of 2024, the company's revenue reached 1.304 billion yuan, continuing to maintain high-speed growth, with a growth rate of 61%.

Judging from the potential of its product pipeline built on vision, Sinocell's growth has just begun. Perhaps, in the current innovative drug market, Sinocell's development trajectory can provide some useful inspiration for the market.

According to the semi-annual report, the growth engine of Sinocell's performance is the recombinant factor VIII Anjiayin®: with outstanding production capacity and cost advantages, market share and penetration have further increased, and sales revenue continues to grow steadily. Of course, a careful study can find that the continued increase in volume of Anjiayin® is certainly due to production capacity and cost advantages, but the deeper reason is that as the first domestically produced recombinant factor VIII, it has made up for the unmet market demand.

Hemophilia, as a disease of coagulation dysfunction, is not only prone to serious damage during abnormal bleeding, but may also affect joints and other parts in a subtle way, so there is a great demand for treatment. However, before the emergence of Anjiayin®, the per capita use of factor VIII in my country was significantly lower than the world average due to the limited source and technical path of domestic brands. According to the research report data released by Kaiyuan Securities, the per capita consumption of coagulation factor VIII in China in 2018 was only 0.026IU, even lower than that in India.

It is in this context that Anjiayin® came into being. In July 2021, Anjiayin® was approved as the first recombinant coagulation factor VIII in China. With its excellent effect and safety, it broke the import monopoly and effectively increased market supply.

The increase in the supply of Anjiayin® has significantly improved the medication level and physical condition of hemophilia patients in my country, reduced the risk of teratogenicity and disability caused by insufficient treatment, and achieved a win-win situation of economic and social benefits. At the same time, the product also brought continuous and stable income to the company.

In January 2023, Anjiayin® was approved for pediatric indications, further meeting the medication needs of pediatric patients and helping the company's revenue to continue to grow. At present, Anjiayin® still has more room for improvement in meeting patient needs.

On the one hand, the proportion of hemophilia A patients receiving treatment in my country is still low, less than 20% at the end of 2022, which shows that there is a lot of room for improvement behind it. On the other hand, the treatment dosage of hemophilia A patients in my country has not yet reached the international average, and the proportion of patients undergoing preventive treatment is relatively low. This also means that there is still room for increase in per capita dosage.

In the process of helping more patients in my country receive treatment and ensuring adequate use, Anjiayin® will continue to expand its supply and continue to increase its volume. Adhering to the vision of "focusing on the research and development of urgently needed drugs for the people and providing patients with high-quality and affordable biological drugs", Sinocell's achievements are not limited to the first domestically produced recombinant factor VIII, but have implemented a two-wheel-driven R&D strategic layout, and subsequent pipelines are ready to go.

On the one hand, for the field of biological drugs where the market is mature but the price may still be expensive, Sinocell hopes to use its strong process and cost advantages to benefit more patients. Based on this logic, products such as Repatuzumab Injection, Adalimumab Injection, and Bevacizumab Injection have been approved one after another. On the other hand, Sinocell focuses on areas where clinical needs have not yet been met and has laid out multiple potential improved or best-in-class product pipelines. For example, the new crown vaccine, 14-valent HPV vaccine, and IL-17 monoclonal antibody.

At present, the demand for COVID-19 vaccination still exists. The new variant strain XEC is raging overseas, and some experts predict that the strain may spread in winter. According to the national COVID-19 vaccination policy, the target population who have completed basic immunization or have been infected with the new coronavirus can receive a dose of vaccine containing XBB variant antigen components 3-6 months after the last vaccination or 6 months after the last infection. At present, the COVID-19 vaccine has been transferred to self-payment, which means that Sinocell can collect reasonable commercial returns based on its R&D investment.

The prospects of the 14-valent HPV vaccine are also exciting. "Valence" refers to the types of viruses contained in the vaccine. The higher the "valence", the wider the types of HPV virus subtypes that can be prevented, and the higher the protection rate. However, as the "valence" increases, the difficulty of R&D and industrialization will also increase accordingly. At present, the highest-priced HPV vaccine on the global market is 9-valent. Faced with the challenge that the protection rate of HPV vaccines still has room for improvement, Sinocell took the lead in investing in the research and development of 14-valent HPV vaccines, and has completed the third injection of the Phase 3 clinical study, and is currently in the follow-up stage.

According to the nine-valent HPV vaccine approved for marketing in my country, the age range for vaccination is 9 to 45 years old. Based on the 310 million female population aged 9 to 45 in China, the penetration rate of the nine-valent HPV vaccine is only about 10%. In contrast, the penetration rate of developed countries in Europe and the United States is as high as 50% to 60%, which means that the penetration rate of high-priced HPV vaccines in my country has great room for improvement. For this reason, Sinocell's 14-valent HPV vaccine has the possibility of continuous volume growth in the future. In addition, Sinocell's multiple pipelines in core areas such as tumors and autoimmune diseases are also based on the same concept and are being accelerated.

For example, the two indications of PD-1 monoclonal antibody SCT-I10A monotherapy for the first-line treatment of head and neck squamous cell carcinoma and combined with bevacizumab for the first-line treatment of hepatocellular carcinoma have been accepted in November 2023 and January 2024, respectively, and the registration site verification of the two indications has been successfully completed. According to the past NMPA approval rhythm, SCT-I10A may be approved in the near future, becoming a powerful helper for Sinocell to realize its vision.

At the same time, the company's independently developed monoclonal antibody product SCTC21C for the treatment of CD38-positive hematological malignancies, bispecific antibody product SCTB35 for the treatment of CD20-positive B-cell non-Hodgkin's lymphoma, and bispecific antibody product SCTB14 for the treatment of various solid tumors have all started Phase I clinical studies. IL-17 monoclonal antibody SCT650C is conducting a domestic Phase Ib clinical study for psoriasis, and has launched a global multicenter (including Turkey and China) Phase II clinical study for the indication of axial spondyloarthritis (ankylosing spondylitis).

Sinocell has great ambitions and hopes to bring more high-quality and affordable biological drugs to patients through unremitting efforts, which also constitutes the underlying logic of Sinocell's continued growth. Whether it is Merck, Johnson & Johnson, Eli Lilly, or Novo Nordisk, the core values of these well-known pharmaceutical companies are centered around the purpose of producing medicines for patients. It is this firm belief that enables their products to be continuously updated and iterated, and eventually become a generation of drug kings.

In the field of innovative drugs, quality, cost and effect constitute the three pillars of corporate competitiveness. In these three dimensions, Sinocell has continuously pursued excellence, and has established its core competitiveness in the industry by ensuring the high quality of drugs while showing advantages in cost control and efficacy improvement.

At the same time, the policy's emphasis on and support for the innovative drug industry has provided a good opportunity for the development of socially responsible pharmaceutical companies such as Sinocell. At the beginning of July, the "Implementation Plan for Supporting the Development of Innovative Drugs in the Whole Chain" was reviewed and approved by the State Council Executive Meeting. It will strengthen policy guarantees, coordinate the use of price management, medical insurance payment, commercial insurance, drug allocation and use, investment and financing and other policies, optimize the review and approval and medical institution assessment mechanism, and work together to promote the breakthrough development of innovative drugs.

In addition to the top-level policy plan, Beijing, Shanghai and other places have also successively issued relevant industrial development policies. With the deepening of medical reform and the implementation of various support policies, Sinocell can continuously and efficiently bring innovative drugs to the market and quickly respond to patients' medical needs.

In this process, the company will also receive corresponding returns. As George W. Merck said, "As long as we stick to this belief, profits will follow."

At its root, the reason why a pharmaceutical company can go far is whether it can always keep its original intention, insist on innovation, and be patient-oriented in the ever-changing market environment. Continuously provide high-quality products and services. For companies like Sinocell, they are already on the road, and are moving towards a more glorious future with solid steps.

https://mp.weixin.qq.com/