In the treatment process of hemophilia, a considerable number of patients will produce "inhibitors" after infusion of coagulation factors, which greatly reduces the treatment effect and is jokingly referred to as the ultimate "big boss" in the industry. Now, with a new inhibitor hemophilia drug derived from the venom of the round spotted viper, STSP-0601 (Pomotaxime alpha), which is still in the approval stage, Shutai Shen (300204. SZ) has once again entered the spotlight of the capital market.

When the annual report was released in March 2025, Shutai Shen suffered losses for five consecutive years, with core product revenue shrinking and a shortage of R&D resources. In the following months, the stock price of this old pharmaceutical company soared and returned to the center of the capital market in an extremely dramatic way, achieving a growth rate of over 700% within six months, becoming one of the undisputed "monster stocks" in the A-share pharmaceutical sector in 2025.

How can this "snake venom remedy", from "death with a reprieve" to "sealing the gods", make Shu Tai Shen, who is deeply mired in losses, "come back to life"?

The Unfinished War of Hemophilia: From "Is There" to "Is It Good or Not"

There is a group of people whose lives are as fragile as glass - a slight collision can cause uncontrollable bleeding, so they have to live in constant caution. They are hemophilia patients known as "glass people".

Hemophilia is a serious hereditary bleeding disorder characterized by coagulation dysfunction. There are more than ten coagulation factors in the human body, and hemophilia patients have a significantly higher tendency to bleed due to the lack of the eighth or ninth factor in their blood. Even minor injuries can cause more severe bleeding, and severe patients may also experience spontaneous bleeding without trauma.

According to the "Chinese Hemophilia Diagnosis and Treatment Report 2023", the incidence of hemophilia in China is around (2.73-3.09)/100000. Based on a population of 1.4 billion, there are approximately 40000 hemophilia patients in China, with male patients accounting for the majority.

According to the different types of coagulation factors lacking, hemophilia is mainly divided into two types: hemophilia A (type A) lacking coagulation factor FVIII (factor eight), and hemophilia B (type B) lacking coagulation factor FIX (factor nine). Among them, hemophilia A is the most common type of hemophilia, accounting for about 80% -85% of all hemophilia patients.

The main strategy for treating hemophilia is to "supplement what is lacking", which means supplementing exogenous coagulation factors (i.e. "coagulation factor replacement therapy"). At present, the commonly used drugs in clinical practice are human derived or recombinant coagulation factor VIII (factor VIII, used for hemophilia A) and coagulation factor IX (factor IX, used for hemophilia B).

The treatment of hemophilia has undergone several changes, and the emergence of recombinant clotting factors (FVIII/FIX) is undoubtedly a major breakthrough in the history of hemophilia treatment worldwide. This drug, produced using genetic engineering technology, can completely eliminate blood dependence for hemophilia patients and avoid the risk of blood virus infection that may arise from extracting clotting factors from plasma.

In recent years, the field of hemophilia treatment in China has also experienced several significant turning points. Especially with the successive launch of domestically produced recombinant coagulation factor products, the annual treatment cost for patients has been reduced from hundreds of thousands of yuan to less than 100000 yuan, which has greatly promoted the penetration rate of hemophilia treatment. More and more patients are no longer "sighing at the drugs".

But the progress of medicine is endless. Professor Sun Jing, a professor and chief physician of the Hematology Department at Southern Hospital of Southern Medical University, pointed out to a reporter from the Science and Technology Innovation Board Daily that our hemophilia treatment is still in the stage of just crossing the "food and clothing line" - although we have solved the problem of "whether there is", there is still a gap between "whether it is good or not".

For example, the coagulation factors currently used in clinical practice often require 3-4 intravenous injections per week. This means that patients have to endure the pain of more than 150 injections per year. The dilemma of "bleeding without needles and getting injured with frequent needles" has made patients look forward to longer and more convenient treatment options.

In addition, a considerable number of hemophilia patients will produce "inhibitors" (antibodies that resist clotting factors) after infusion of clotting factors. These antibodies attack the infused clotting factors like "drug nemesis", leading to a decrease or even failure of treatment efficacy. It can be said that in the treatment process of hemophilia, inhibitors are one of the most headache inducing obstacles for doctors.

Sun Jing told reporters from the Science and Technology Innovation Board Daily that "hemophilia with inhibitors" is the most serious and difficult complication in the treatment of hemophilia, with about 30% of severe hemophilia A patients producing inhibitors. "This proportion is still quite high.

Generally speaking, patients with severe hemophilia A are more likely to produce inhibitors because they have almost no clotting factors in their bodies. During the initial period of receiving clotting factor replacement therapy, their bodies will automatically produce immune antibodies against that clotting factor. Once the inhibitor is' positive ', the difficulty of treatment will double or become ineffective, and in severe cases, it may even increase the disability and mortality rates of patients. ”Sun Jing told reporters.

It is reported that for the treatment of hemophilia with inhibitors, there are currently different clinical methods such as immune tolerance therapy (ITI), bypass pathways, and non factor therapies, but all of them have shortcomings.

Immune tolerance therapy (ITI) is the standard therapy for clearing inhibitors. Its mechanism of action is similar to desensitization therapy, for example, hemophilia A patients can promote immune system tolerance by continuously administering small doses of factor eight in combination with immunosuppressants. However, such treatments often require a duration of six months to several years or more, which is not only time-consuming but also costly. ”Sun Jing stated.

At the same time, for bleeding events with hemophilia accompanied by inhibitors, it is often necessary to stop bleeding through a bypass route. There are mainly two types of drugs in the bypass pathway, namely prothrombin complex (PCC) and recombinant human factor VII a (rF VII a, recombinant factor VII).

But Sun Jing said that the weakness of prothrombin complex is the relatively large side effects of treatment, which can easily lead to thrombosis. And the price of recombinant seven factor drugs is very expensive, "it costs 20000-30000 yuan to administer once, and because the half-life of the drug is relatively short, it needs to be administered almost every three hours, which costs nearly 200000 yuan per day. Very few patients can afford it.

The traditional classic drug for recombining the seven factors is NovoSeven from Novo Nordisk, with global sales of up to 1.158 billion US dollars in 2024, while sales in China are only 160 million yuan. Despite the fact that the first domestically produced drug of its kind, Zhengda Tianqing, is an injectable recombinant human coagulation factor VIIa (Anqixin) ®） Just got approved last month, but Sun Jing told reporters that the treatment cost is still not low.

Shu Tai Shen's capital feast: Old drugs lose their power, gamble heavily on new drugs

Overall, there are relatively abundant treatment options for hemophilia without inhibitors worldwide, while treatment options for hemophilia with inhibitors are still relatively lacking. Available drugs are either not effective enough or too expensive to afford.

This is precisely the vacuum zone that Shutai Shen is eyeing.

STSP-0601 currently has two indications being promoted in clinical practice, including on-demand treatment for hemophilia patients with inhibitors and on-demand treatment for hemophilia patients without inhibitors. According to market analysis predictions, if STSP-0601 is successfully launched in the sub field of inhibitors, its domestic sales peak is expected to exceed 2 billion yuan. This is undoubtedly a disruptive imagination space for Shu Tai Shen, which had a revenue of only over 300 million yuan and was deeply mired in losses in the previous year.

According to the journalist's review of public information, STSP-0601 is an innovative coagulation factor X activator (factor 10 activator), and its active ingredient is extracted from the venom of the round spot viper. In terms of mechanism of action, STSP-0601 is similar to recombinant seven factor products, cleverly bypassing the VIII or IX factors that traditional coagulation factor replacement therapy relies on, and directly activating downstream factor X. This is equivalent to opening up a "secondary pathway" for hemostasis when the coagulation pathway is blocked by inhibitor antibodies.

The development of STSP-0601 actually began as early as 2019, but it wasn't until this year that the company's stock price was completely ignited. Along with every positive news from STSP-0601, the stock price of Shutai Shen has caused significant fluctuations at critical junctures such as the announcement of IIb results and the acceptance of listing applications, with astonishing short-term gains.

One important reason behind this is that the market expects this drug to potentially cross phase III clinical trials, obtain "conditional marketing" approval based on phase II clinical data, and enter commercialization ahead of schedule.

At the beginning of the year, Shutai Shen announced that it had obtained the Phase IIb clinical summary report, and the data met the predetermined primary efficacy endpoint. The announcement clearly states that both Phase Ib/II and Phase IIb results demonstrate that STSP-0601 has good on-demand hemostatic effects. The company immediately announced that it will advance the preparation for conditional listing application.

In early June, the company once again announced that the conditional listing application for STSP-0601 had been accepted by the National Medical Products Administration and included in the priority review sequence. After this news came out, the stock price hit the daily limit up of "20cm".

However, under the carnival, there were undercurrents surging, and the biggest level was still approval. It should be noted that conditional marketing often applies to drugs that treat serious life-threatening diseases or urgent public health needs for which there are no effective treatment methods.

And in recent years, there has been a continuous tightening trend in relevant policies, such as the latest revised draft for 2025, which requires applicants to initiate confirmatory clinical trials before conditional listing, and restricts duplicate applications for drugs with the same target to avoid homogeneous competition.

Acceptance does not necessarily mean approval. There is still some uncertainty about whether STSP-0601 can become the "lucky one" as it wishes.

On the other hand, the soaring stock price of Shutai Shen cannot be separated from the boost of the A-share pharmaceutical market this year. After a deep adjustment in the early stage, A-share pharmaceuticals will experience a strong rebound in 2025. Investors often have a higher risk tolerance for innovative pharmaceutical companies that are in a critical stage of research and development or have strong BD expectations.

On June 28th, STSP-0601 was granted orphan drug status by the US Food and Drug Administration (FDA) for the treatment of hemophilia A and hemophilia B, which is considered a shortcut to the internationalization of STSP-0601.

However, it is worth noting that the cash and cash equivalents balance of Shutai Shen at the end of 2024 was only 53.5493 million yuan. In terms of funding, talent, and market access prospects, compared to building a self built team to go global, choosing to license out or cooperate with MNC for development is obviously a better way. However, so far, there has been no BD news from STSP-0601.

What cannot be ignored is that the continuous five years of losses are consuming the cash reserves of Shutai Shen. Advancing the Phase III clinical trial of STSP-0601, establishing production lines, and preparing for commercialization all require huge amounts of capital. Can the cash flow of this pharmaceutical company support the profitability of new drugs?

The story of Shu Tai Shen was once a successful model for domestic pharmaceutical companies. After its establishment in 2002, relying on the constipation drug "Shutaiqing" approved in 2004 and the optic nerve injury drug "Sutisheng" launched in 2006, this old pharmaceutical company once enjoyed great success. However, the vulnerability of a single product line has been exposed in the face of policy changes.

In 2019, Su Peptide was included in the national key monitored rational use drug list, and the company's revenue fell accordingly. According to the 2024 financial report, the two "veteran" products, Shu Taiqing and Su Peisheng, contributed a total revenue of 314 million yuan, accounting for more than 96%, highlighting their lack of innovation and lack of successors.

After losing its policy advantage, Shu Tai Shen has been plunged into a loss abyss since 2020, with a huge loss of 133 million yuan that year. As of 2024, the company has suffered losses for five consecutive years, and the pressure of transformation is imminent. During this period, although we tried to layout hot areas such as COVID-19 and hepatitis B, they all ended in failure, and the R&D pipeline was not connected.

The "decline of old drugs+repeated failures in research and development" was once an inescapable label for Shutai Shen, and its predicament is also a microcosm of many traditional pharmaceutical companies. But the emergence of STSP-0601 rewrote the script, not only winning the breakthrough therapy recognition of CDE with phase IIb clinical trials, but also triggering crazy capital bets. Someone joked, "Looking at the stock price trend, those who don't know might think hemophilia has been conquered

From drug approval to eventual conversion into stable profits, there is still a long and variable chain, and the frenzy of the capital market will eventually recede. Only the true clinical value of drugs and the commercialization ability of enterprises are the cornerstones that support long-term value.

Under the applause and foam, the climax of the story has come, but the end has not yet been written. In this era of universal storytelling, where will the 'snake venom miracle' of STSP-0601 go? Before the answer is revealed, all floating wealth is just paper wealth; After the answer was revealed, we found out who was swimming naked.

责编: editor