More convenient drug delivery methods, lower side effects, and higher survival rates... In the already booming field of anti-tumor drugs, there are still competitors constantly providing better solutions.

Recently, the FDA approved the marketing of BMS's Opdivo subcutaneous injection Opdivo Qvantig (nivolumab plus hyaluronidase), which also means that Opdivo is a latecomer, crossing the "KO battle" and becoming an earlier PD-1 subcutaneous formulation approved for marketing.

Compared with the traditional intravenous infusion method that usually lasts for more than half an hour, subcutaneous preparations can be administered within 3-5 minutes, greatly improving patient comfort and convenience in medication. Of course, this administration method also has certain requirements for the difficulty of drug development.

In September 2024, Roche also released a subcutaneous version of its PD-L1 antibody Tecentriq. It is worth noting that the subcutaneous formulation version of PD-L1 drugs does not come from multinational pharmaceutical companies, but from domestic innovative pharmaceutical companies.

As early as three years ago, Sinopharm (1244. HK) became the world's first innovative drug - subcutaneous injection of PD-L1 inhibitor Envolumab Injection (trade name: Envolumab) ®） It has already been approved for marketing, which is one of the earliest approved single domain antibody treatments for tumors in the world, and the dosage is only 0.75ml, completed in 30 seconds without the assistance of hyaluronidase. As of June 30th this year, it has contributed over 1.5 billion yuan in sales revenue to this Hong Kong listed biotech company.

Supported by research and development capabilities, we are advancing the commercialization process

Unlike biotech companies like 18A, which have no income, Enweida ® The approval for listing was even earlier than the listing of Sinopharm on the capital market.

At that time, the popularity of PD-1/PD-L1 had swept both domestically and internationally, which meant that the later the product was launched, the more difficult it was to seize market share, and time and speed were crucial. Considering the rapidly changing market situation, Sinopharm has chosen the differentiated PD-L1 Envida among numerous products ®， Corning Jerry is responsible for early development, while Sinopharm is responsible for global clinical, registration, and commercialization.

Approaching the commercialization stage, Sinopharm has reached a cooperation agreement with Xiansheng Pharmaceutical, with the latter responsible for Envida ® Exclusive commercial promotion service after registration and listing in Chinese Mainland. From the signing of the cooperation agreement to the final approval for listing, Enweida ® It only took over 4 years, setting a faster record among similar innovative drugs at that time.

Enweida ® The listing of Sinopharm has opened the door to commercialization for Sinopharm. It can complete subcutaneous injection administration in just 30 seconds, far lower than the 1-2 hour administration time of other PD - (L) 1 treatments on the market at that time. It has a smaller dosage and shorter time than similar subcutaneous injections reported earlier, and can even achieve outpatient treatment.

In 2023, Nvidia ® The annual sales revenue in China reached 634.9 million yuan, an increase of 11.9% compared to 567.4 million yuan in the same period of 2022 (the first full sales year). Thanks to this, Sinopharm further reduced its losses, with the amount of losses narrowing from 1.052 billion yuan in 2022 to 562.5 million yuan in 2023.

However, after entering 2024, due to intensified market competition, Nvidia ® Sales are under pressure, with revenue of 206 million yuan in the first half of this year, a decrease of 41.4% compared to the same period last year. But residents' demand for medical consumption must be to pursue more optimized and convenient drugs. Envida is currently conducting perioperative clinical trials for lung cancer, and we believe this will become a new source of revenue growth for the product.

It is worth mentioning that Nvidia ® Expected to increase volume in the global market. In October 2023, Nvidia ® The clinical phase III study of the combination of lenvatinib and carboplatin paclitaxel has been approved by the US FDA. In January 2024, Envida was approved ® Part of the overseas market equity was sold to international pharmaceutical company Glenmark for $700 million, while Sinopharm still retains its equity in multiple locations such as the United States, Europe, and Japan.

Since its establishment 10 years ago, looking back at the development process of Sinopharm, whether it is the rapid advancement of clinical trials or the precise selection of partners, it is sufficient to see that the executive team behind Sinopharm has a clear understanding and profound comprehension of the pharmaceutical industry. It is precisely the precise and professional decision-making like a surgical knife that drives the company's continuous upward development path.

Public information shows that in his nearly 20-year career, Gong Zhaolong, Chairman and CEO of Sinopharm, has served as an FDA reviewer for 10 years, Chief Technology Officer of Zhaoyan New Drug, Vice President of Clinical Development at BeiGene, and has participated in clinical research and multi center trials of innovative drugs in China from different perspectives, accumulating rich experience.

Focusing on patient benefits and building a product pipeline

The conquest of cancer has always been a difficult problem in human life. Data shows that the overall five-year survival rate of cancer in China has been increasing year by year. In 2021, the age standardized 5-year relative survival rate of cancer in China has reached 43.7%.

With the continuous maturity and widespread use of tumor immunotherapy, most tumors will gradually become chronic diseases. How to improve the quality of life of cancer patients, provide not only safe and effective, but also convenient treatment plans, and achieve maximum patient benefits, has brought new challenges to innovative pharmaceutical companies in the forefront of cancer prevention and treatment.

Since its listing, in addition to the increasingly mature Enweida ® Outside of the pipeline, Sinopharm has up to 12 research pipelines, covering multiple technical routes including monoclonal antibodies, bispecific antibodies, mRNA platforms, and small molecule anticancer drugs. From the "anti-cancer miracle drug" PD-1/PD-L1, to pain relievers for cancer patients, and to the mRNA platform for future cancer universal vaccines, it can be said that an integrated layout has been made around the slow disease of tumors.

Overall, the product line of Sinopharm not only revolves around a single patient's need, but also emphasizes the maintenance of patients' quality of life while focusing on disease treatment.

The heterogeneity of tumors is high, with significant individual differences. Factors such as age, physical condition, tumor type, stage, and gene mutations can all affect the final treatment plan. Therefore, even if different patients have the same type of tumor, their situation may vary.

Therefore, in the treatment of tumors, it is common to use different treatment methods and drugs in combination, which can provide the best treatment effect and maximum benefit for patients.

As of now, two-thirds of the existing product pipeline of Sinopharm has entered the clinical development stage, and multiple drugs have obtained orphan drug qualifications from the US FDA and the European Medicines Agency. This not only means that the company will continue to launch new products in the future, but also represents the possibility of multiple combinations of drugs with different efficacy in the future.

It is worth mentioning that the peptide tumor vaccine targeting WT1 antigen being developed by Sinopharm is expected to become a universal cancer vaccine platform, covering two categories: hematological tumors and solid tumors. It is bound to become a major explosive product when it is launched in the future.

The long-term ideal of the company is to create a product that has an impact in the global market. From the current pipeline reserves, multiple pipelines under research have such potential. At the same time, the listing of Enweida also provides the company with a continuous stream of cash flow to support future R&D investment. "When talking about the future development direction of Sinopharm, Xia Fang, Vice President and Secretary of the Board, said.

Conclusion

Since the Hong Kong Stock Exchange introduced Chapter 18A of the Listing Rules in 2018, allowing unprofitable biotechnology companies to list in Hong Kong, over 50 innovative pharmaceutical companies have entered the capital market through the Hong Kong Stock Exchange's 18A platform as of now.

Embarrassingly, the successful launch of an innovative drug cannot be separated from the "Double Ten Law", which requires a research and development investment of one billion US dollars and a listing process of more than ten years. In the capital hot stage, investors and entrepreneurs may be overly optimistic about future investments, leading to indecision in order to sustain operations during the capital cold winter.

It has to be said that in the current slightly sluggish pharmaceutical market, investors are more inclined to focus on companies with successful cases, strong research and development capabilities, and high team execution. Of course, product pipelines with high potential and the potential to bring substantial commercial profits in the future are extremely rare targets in the current market.

High risk and high return are evident in the innovative drug value chain, but the human demand for health is endless. China also urgently needs the emergence of globally competitive pharmaceutical companies to promote the development of the entire biopharmaceutical industry. The moment that tests the value of each enterprise is right in front of us.