In 2023, most of the biotech stocks listed in Hong Kong have underperformed, even BeiGene (06160.).HK), Junshi Biosciences (01877HK) such a faucet has not escaped the fate of **. On the contrary, it is a new stock listed on June 29, Laika Pharmaceutical-B (02105.HK) performed wellIn 2023, it has risen by more than 60%.
However, the good times did not last long, and after entering 2024, Laikai Pharmaceutical suddenly "changed its face", and its stock price fell sharply all the way, and there was no turning back at all. Until January 30,Its share price has fallen by more than 78% in a monthQuite tragic.
With such a big contrast in stock price performance, what happened to Laekna Pharmaceutical?
What is the share price**?
Laekna Therapeutics is a clinical-stage biomedical technology company with a focus on cancer and liver fibrosis. As of mid-2023,Laekna has two core productsand more than 10 other pipeline product candidates. WhileBoth core products have been approved by Novartis Pharmaceuticals (NVS.).us) authorized to be introduced.
Among them, the core product LAE002 is an adenosine triphosphate (ATP)-competitive AKT inhibitor for **ovarian cancer, prostate cancer, breast cancer and PD-1 PD-L1 resistant solid tumors.
Another core product, LAE001, is an androgen synthesis inhibitor, which can simultaneously inhibit cytochrome P450 family 17 subgroup A member 1 (CYP17A1) and cytochrome P450 family 11 subgroup B member 2 (CYP11B2) for prostate cancer.
Combined with the recent situation, Laekna Pharma will be in 2024One of the reasons is that the overall environment is relatively poor, and the market's ability to undertake is weak.
In fact, the Hang Seng Index is down nearly 8% year-to-dateLaekna Pharmaceutical's biomedical B stock index fell by more than 24%. This shows that the performance of the entire market is not very good, and the biomedical field is the "hardest hit area", which is Ascletis Pharmaceutical-B (01672HK) and a very small number of **recorded**.
In addition,The lifting of the ban on cornerstone investors is also the direct trigger for this round of Laekna Pharmaceutical.
According to publicly available information,On December 29, 2023, Laekna Pharma ushered in the lifting of restricted shares, of which the number of shares released by cornerstone investors reached 5,480650,000 shares, representing 1405%，It involves shareholders such as Ningbo Yaoshangyan Chuangchenkai Equity Investment Partnership (Limited Partnership) and Advanced Manufacturing Industry Investment **Phase II (Limited Partnership).
And the data shows that on January 11, 2024,Liu Zeng, the actual controller of Ningbo Yao Shangyan Chuangchenkai Equity Investment Partnership (Limited Partnership), sold 36 at an average price of 15 Hong Kong dollars70,000 shares.
In the strong ***, in the face of surging buying, the negative news is easy to digest, which is the so-called "boots on the ground". In the weak **, a little wind and grass can trigger capital smashing, the negative is really negative, will not be transformed into good, and a large number of restricted shares are obviously heavy negative, its power is not difficult to imagine.
In fact, there have been a lot of stock prices due to the lifting of restricted shares recentlyLehua Entertainment (02306.)HK), Baiguoyuan Group (02411HK) has also suffered from this.
Another one,The unstoppable decline of Laika Pharmaceutical is also related to an announcement disclosed a few days ago.
Specifically, after trading on January 28, Laekna disclosed the topline data of the international multicenter registration phase II clinical trial (PROFECTA-II) of afuresertib (LAE002) in combination with paclitaxel in patients with platinum-resistant ovarian cancer (PROC) in the United States and China.
The results of the trial showed that afuresertib (LAE002) combined with paclitaxel peritherapyThe risk of disease progression or death (progression-free survival, PFS) may be reduced, but trials were not statistically significant.
Laekna said that the company plans to discuss with regulators to determine the next step in the registration clinical pathway based on the results of the trial. Detailed trial data will be presented at a medical session.
LAE002 is one of the core drugs of Laekna TherapeuticsCombination with paclitaxel**PROC (2nd to 6th line**) is one of the two fastest-growing indications.
Today, the failure of the trial to achieve statistical significance is in some way a failure, which negatively impacts the commercialization process of Laekna Therapeutics.
WhileLaekna Pharma has not yet achieved commercialization, and its performance continues to lose moneyExpectations for LAE002 were high, so the test results were not as good as expected.
What are the other highlights of Laekna Pharmaceutical?
Under the multiple bearishness, the share price of Laekna Pharmaceutical fell by nearly 8% in a short period of time, which can be described as an "ankle cut", which also aroused the doubts of many investors.
However, under the catharsis of emotions, this wave of sharp decline of Laikai Pharmaceutical may have fallen a little too much, and the company actually has a lot to pay attention to.
First of all, in addition to LaE002 in combination with paclitaxel**PROC (2nd to 6th line**), Lae002 is also expanding the indications of LAE002 in HR+ HER2- breast cancer, MCRPC**migratory androgen blocking**-resistant prostate cancer), TNBC (triple-negative breast cancer), PD-1 resistant cervical cancer and endometrial cancer.
Among them,The clinical trial of MCRPC (second to fourth line**) after LAE002 in combination with LA001 and prednisone for the indication of SCO (sequential optimal combination, a commonly used **method**) has been carried out to the second phase of clinical trials in the United States and South KoreaIt is the most advanced research progress at present.
In addition, another core product of Laekna PharmaceuticalsLAE001 is the only dual inhibitor of CYP17A1 and CYP11B2 in clinical trials for prostate cancer in the world, which can block the synthesis of androgens and aldosterone at the same timeand can be administered without prednisone, which may be associated with a variety of adverse events when receiving high doses in short periods or cumulative doses over a long period of time.
Hormone-sensitive prostate cancer (HSPC) is the stage in which patients with prostate cancer develop an effective response to hormones**, usually androgen deprivation** (ADT). MHSPC is a type of prostate cancer that has spread to other parts of the body.
According to the research report released by Hua Chuang**,In 2020, the prostate cancer market reached the $10 billion levelThe only first-line drugs are a few AR antagonists, such as abiraterone and enzalutamide.
The indication of LAE001 is that MHSPC (first-line**) is expected to overcome the deficiency of abiraterone, which is worth paying attention to.
However, LAE001 also faces stiff competition from a number of potential competitors. According to incomplete statistics,There are seven anti-androgen drugs approved for global (excluding China) commercialization, and seven anti-androgen drugs approved in China.
In addition to these two core products, Laekna Therapeutics' LAE102 is also attracting attention.
LAE102 is the most mature drug candidate independently developed by Laekna for use as ** cancer. This is a potentially potent and selective Activin receptor type II (Actriia) monoclonal antibody (mAb) that has demonstrated anti-tumor activity and increased body weight in tumor-bearing animals in preclinical animal models.
However, the market is not looking at the future of LAE102** cancer.
It is understood that in adipocytes, activin directly promotes lipid storage through Actrii receptors and is a key driver of visceral fat accumulation and obesity. In muscle cells, Actrii receptor-conducted signaling pathways inhibit muscle growth and promote atrophy. Blocking activin signaling in skeletal muscle can inhibit this atrophy and can promote an increase in muscle mass, helping obese patients improve body composition and metabolism while along.
In recent years, the market prospects in this field have been widely optimistic.
And according to the opinion of the institution,The world's first Actriia monoclonal antibody LAE102 can increase muscle and reduce fat, and has the potential to be used in combination with GLP-1RA, with huge market potential and international value.
In the 2023 interim report, Lae102 is the company's first self-developed antibody and has received IND approval from the FDA in May 2023. The Company will first study the application of LAE102 in cancer indicationsIn the later stage, the application of LAE102 in obesity and metabolic diseases, pulmonary hypertension and other disease indications will be explored.
It should be noted that the LAE102** cancer indication is expected in the first half of 2024Phase I trial in the United States. At present, it is still only in the "imagination" stage to talk about the use of LAE102 for the indications of obesity and metabolic diseases, and it is difficult to say how it will be in the future.
Conclusion
On the whole, under the pressure of multiple bearishness, the share price of Laikai Pharmaceutical has suffered a series of **, but the company is not useless, there are still some highlights, and the follow-up development is still worth tracking.
Author: Yun Zhifeng Qi.