Amid the ever-changing capital market, the increase in the share price of Beihai Kangcheng is undoubtedly a remarkable and phenomenon-level event.

Starting from a low of HK $0.13 at the beginning of this year, the share price of Cansino Biologics has been surging. As of the close of trading on August 13th, it has soared to HK $2.1, achieving an astonishing growth of over 15 times compared to the beginning of the year, with an increase of as high as 1,515%. This astonishing increase has become a hot topic of discussion in the capital market.

In the current highly competitive pharmaceutical industry and with rapidly changing policy environments, why has the share price of Cansino Biologics been able to soar and become a favorite of the capital market?

Good news keeps coming

The share price of Beihai Kangcheng has soared, mainly due to the recent dual positive factors.

On August 13th, Cansino Biologics announced that it had reached a share subscription agreement with Baiyang Medicine. According to the agreement, Baiyang Medicine will subscribe for approximately 74,971,468 new shares of Cansino Biologics at a price of HK $1.34 per share, investing HK $100 million. After the subscription is completed, its shareholding ratio will change significantly, accounting for approximately 17.65% of Cansino Biologics' existing issued share capital. And 14.99% of the enlarged share capital.
As a leading player in the domestic rare disease field, Beihai Kangcheng has been deeply engaged in the research and development and commercialization of rare disease drugs for many years. However, the domestic payment environment has limited support for high-priced rare disease drugs, which has put certain pressure on its revenue growth.

Baiyang Medicine, relying on its profound strength in the innovative brand commercialization platform, has extensive channel resources and strong marketing capabilities in the field of pharmaceutical commercialization. This cooperation is undoubtedly an excellent example of complementary advantages.

This strategic equity financing is of great significance to Beihai Kangcheng. On the one hand, it can optimize its commercial business model and enhance its commercial operation strength; On the other hand, accelerate the market penetration of already launched products and further enhance market competitiveness.

As soon as the news was released, the market reacted promptly and strongly. The share price of Beihai Kangcheng rose continuously after the opening on August 13th. By the close of trading on that day, the increase was as high as 25.75%. This phenomenon fully demonstrated the market's high recognition and positive expectations for this cooperation.

Not only that, but the products under Cansino Biologics have also been enjoying continuous benefits.

In 2025, the National Healthcare Security Administration established the "Commercial Insurance Innovative Drug Catalogue" for the first time and officially launched the application process on July 11. On August 12th, three products of Cansino Biologics, namely, Gorenin (Viracinase β for Injection), Meirui Bei (oral solution of clomaxitabate), and Hairui Si (Injection of Edosulfatase β), passed the initial review and are expected to accelerate market access.

Gorinin: Mainly used for the treatment of Gaucher's disease. Gaucher's disease is a genetic disorder caused by a deficiency of glucocerebrosidase, which can affect multiple organ systems. Gorelin, as an enzyme replacement therapy, can supplement the enzymes lacking in patients' bodies and improve their conditions.

Meirubei: A drug used to treat cholestatic pruritus in patients with Alagari syndrome (ALGS). ALGS is a rare hereditary liver disease. Patients often experience severe itching and other symptoms caused by cholestasis. Meiruibei alleviates patients' pruritus symptoms by inhibiting ileal bile acid transporters and reducing bile acid levels.

Haisi: An enzyme replacement therapy introduced by Cansino Biologics from South Korea for the treatment of the rare disease mucopolysaccharidosis type II. Mucopolysaccharidosis type II is a rare hereditary lysosomal storage disease, mainly caused by the deficiency of iduronate-2-sulfatase enzyme. Heris improves patients' symptoms and quality of life by supplementing the enzymes lacking in their bodies.

The act of passing the initial review list is of great significance to Cansino Biologics.

First of all, passing the initial review means that the innovation and clinical value of these three products have been officially recognized, laying a solid foundation for their future market promotion. Secondly, if a drug is included in the commercial insurance innovative drug list, it will receive support from commercial insurance, and the economic burden on patients' medication is expected to be reduced, thereby enhancing the accessibility of the product.

Previously, it reached a strategic cooperation agreement with Baiyang Medicine and received strategic investment. Then, it received the major news that three core products passed the initial review of the commercial insurance innovative drug list. Beihai Kangcheng has demonstrated the outstanding performance of its products in terms of innovation and clinical value to the market. In the current situation where the attention and demand for rare disease drugs in the market are constantly rising, the sharp increase in Beihai Kangcheng's stock price is also reasonable.

A dark horse in rare disease drugs

When it comes to Cansino Biologics, it is impossible not to mention its independently developed drug for treating Gaucher's disease - Gorinin.

Gaucher's disease is a familial genetic disorder caused by a deficiency of glucocerebrosidase, which leads to the accumulation of glucocerebrosidase in lysosomes, resulting in symptoms such as hepatosplenomegaly, anemia, thrombocytopenia, and bone pain. In severe cases, it may be life-threatening.

Before the launch of the first self-developed product, Gorelin, by Beihai Cangcheng, the treatment options for Gaucher's disease included drug treatments such as substrate reduction therapy, for instance, miglustaru and eliglustaru. These drugs were convenient to take orally and had a relatively high patient compliance rate, but they had some adverse reactions, such as diarrhea and abdominal pain.

In particular, for some patients with severely enlarged spleens, causing compression symptoms or extremely reduced platelets, splenectomy may be considered. However, after splenectomy, the patient's immunity will decline, the risk of infection will increase, and it may accelerate the progression of the disease, leading to the involvement of other organs.

In May this year, the launch of Gorinin brought new hope to patients with Gaucher's disease.

The Gonine (Viracinase β for Injection) independently developed by Cansino Biontech has been approved for marketing by the NMPA and is used for long-term enzyme replacement therapy in adolescents and adults aged 12 and above with type I and type III Gaucher's disease.

Golinin is the first domestically developed recombinant human cerebrosidase replacement therapy in China that has entered clinical application for the treatment of patients with type I and type III Gaucher's disease. Most patients with Gaucher's disease are of type I and type III, which are respectively chronic non-neuropathic and chronic neuropathic. Viracinase β specifically supplements glucocerebrosidase, which is lacking in lysosomes in patients with Gaucher's disease, through intravenous infusion.

The pivotal clinical trial of Gorelin achieved positive top-line data in August 2024. It was a randomized, double-blind, dose-comparison study aimed at evaluating the efficacy, safety, and pharmacokinetics of intravenous infusion of viracinase β once every two weeks in patients with newly diagnosed Gaucher's disease, with an open-label extension period.

The results indicated that the study was conducted in the 60U/kg dose group (P< 0.0001) and the lower 30U/kg dose group (P< 0.001) All successfully achieved their primary efficacy endpoint, which was the average percentage reduction in the spleen volume of the subjects from baseline after 9 months of treatment. Its efficacy and safety in the field of enzyme replacement therapy have been verified.

As the first listed company in China specializing in rare disease drugs, Cansino Biologics, in addition to its three commercialized products that have already been launched, also has A portfolio of seven drugs with considerable market potential. These products are all targeted at some common rare disease indications, such as Hunt syndrome and other lysosomal storage disorders, complement-mediated diseases, hemophilia A, and other diseases.

Conclusion

Recently, Cansino Biologics has achieved remarkable success in the field of rare disease drugs. Its pipeline under development covers a variety of rare diseases and rare tumor diseases, demonstrating its in-depth layout and R&D strength in the field of rare diseases.

However, the research and development and commercialization of drugs for rare diseases also face many challenges. The research and development of drugs for rare diseases is costly, time-consuming, technically challenging, and fraught with uncertainties in various aspects such as policies and regulations, as well as market competition. In addition, the payment issue of rare disease drugs is also a significant challenge. Due to the small patient population, high drug prices, and limited medical insurance coverage, to a certain extent, it restricts the accessibility and market promotion of drugs.

How to achieve sustainable development in the field of rare disease drugs and bring more hope to patients remains a complex and multi-party collaborative systematic project.

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