On October 21, Simcere Pharmaceutical announced that its clinical trial application for the innovative breast cancer drug sim0270, which it independently developed, was accepted by the Drug Evaluation Center (CDE) of the State Drug Administration. It is worth noting that this is the third ind in just one month since Sim0395 clinical trial application (IND) was announced by Sim0395 pharmaceuticals on September 29.
From the perspective of market performance, Simcere Pharmaceutical has also begun to rebound at the bottom recently, and the current node may be a rare investment opportunity, which is worth our in-depth discussion of its long-term investment value.
Chart 1: Simcere Pharmaceuticals' recent stock price performance
Source: Oriental Fortune, Compiled by Grande
Sim0270, sim0235 and SIM0395 have submitted ind applications for three drugs. The author's research found that these three drugs have certain similarities, they are all drugs for the field of tumor treatment, of which sim0270 and sim0235 are the independent research and development products of Simcere Pharmaceutical, and they all belong to the cutting-edge drugs in the field they are currently targeting. As small molecule drugs, sim0270 and sim0395 can break through the limitations of the blood-brain barrier, which is expected to bring more benefits to patients with tumor brain metastases.
Among the three drugs, the ind application of SIM0270 on October 21 was accepted by CDE, which is a new generation of oral selective estrogen receptor degrader (SERD) independently developed by Simcere Pharmaceuticals for the treatment of ER+/HER2-type locally advanced or metastatic breast cancer.
Estrogen receptor positivity (er+) is one of the most common subtypes of breast cancer (about 80%), and the occurrence and development of this type of breast cancer is closely related to estrogen and is sensitive to endocrine therapy that targets estrogen. However, about 30% of patients will develop drug resistance during treatment, leading to disease recurrence or metastasis, of which the brain is a common metastasis site of breast cancer, and about 15% of patients with er+ advanced breast cancer have brain metastases, and the incidence is rising.
It is worth mentioning that compared with the dilemma that existing endocrine therapeutic drugs cannot penetrate the blood-brain barrier, sim0270 has made differentiated innovations in molecular structure while maintaining the characteristics and efficacy of the existing oral serd molecules, making it have efficient blood-brain barrier permeability.
In terms of efficacy, its efficacy is significantly better than the only currently listed SERD drug fluorolistrant, and from the perspective of market size, even if the current fulvestrant has shortcomings such as injection trouble and obvious adverse reactions, its global annual sales still exceed 1 billion US dollars, so it can be predicted that the market space for the drug in Simcere Pharmaceutical in the future is extremely large.
Similarly, Sim0235 (sim1811-03), another self-developed innovative anti-tumor drug in Sim0235 (im1811-03), also submitted a clinical trial application to cde on October 8 and was accepted, which is mainly used for the treatment of advanced solid tumors and cutaneous T-cell lymphoma.
SIM0235 is an immunoglobulin g1 (igg1) type humanized anti-tnfr2 monoclonal antibody. Its target is tnfr2, which is a member of the tnf receptor superfamily, which is selectively expressed as a surface oncogene in multiple types of tumors, which has the function of promoting tumor cell proliferation, and is considered to be one of the current targets with great potential.
Figure 2: TNFR2 Mechanism of Action
Source: Company information, compiled by Grandway
Multiple studies have shown that tnfr2 may have specific recognition of the tumor microenvironment, and even more targeted than other immunotherapies to treat tumors, with stronger safety.
At present, domestic and foreign biopharmaceutical companies have successively entered the target, mainly including Simcere Pharmaceutical, Arnold Pharma, BeiGene and so on. In terms of progress, Sim0235 of Simcomer Pharmaceutical has now declared ind, which is in a relatively leading position in China and in the first echelon in the world, and may become another highly competitive new drug in the future.
In addition, Sim0395 (paxalisib), a new drug under development introduced by Simcere Pharmaceuticals, was also accepted by cd on September 29. The main indication targeted by the drug is glioblastoma, which is the most common and malignant primary intracranial tumor in adults. According to a report by the World Health Organization's global cancer research agency, Cancer today, there were 79,000 new cases of brain and central nervous system tumors and 65,000 deaths in China in 2020. Among them, glioblastoma accounts for 48% of all primary malignancies of the central nervous system, which is characterized by high morbidity, high recurrence rate, high mortality rate and low cure rate.
However, as one of the most malignant tumors, the clinical treatment options for the disease are very limited, and the standard treatment methods include surgery, radiation therapy, and temozolomide treatment, but the five-year survival rate of patients is less than 10%. According to the interim data of a Phase 2 clinical study, the median survival (mos) and median progression-free survival (mpfs) of patients with mgmt non-methylated neogligoblastoma with paxalisib for MGMT were 17.7 months and 8.5 months, respectively, compared with the 12.7 months and 5.3 months of the existing standard treatment methods, which were significantly improved.
Moreover, paxalisib, as a small molecule pi3k/mtor pathway inhibitor with high blood-brain barrier penetration, has the hope of expanding to brain metastatic tumors or other tumors with abnormal pi3k pathways in the future, and the drug has been carried out in relevant trials in a number of overseas clinical research centers.
On the whole, sim0270 and sim0395 are drugs that can be targeted at brain cancer and have a high degree of difficulty in research and development. Compared with other therapeutic areas, brain cancer drugs belong to both the field of CNS and the field of tumors, and the risk and difficulty of drug development in these two areas are extremely high, and products with excellent clinical advantages are unattainable.
However, it is worth noting that the reason why Simcere Pharmaceutical has laid out these two products is that on the one hand, it is confident in its research and development strength, and on the other hand, it is because the indications targeted by these two drugs are the clinical needs that need to be met urgently. Whether it is advanced or metastatic breast cancer, or glioblastoma, it is a disease with a large number of patients and some room for improvement in existing treatment options. It is foreseeable that with the continuous advancement of the research and development of these two drugs in Simcere Pharmaceutical in the future, the possibility of bringing effective treatment to such patients will continue to increase.
In less than 2 months from the disclosure of the interim report, Simcere Pharmaceutical's research pipeline has made significant progress in succession, which shows the high efficiency of the company's research and development. At present, the company has a total of nearly 60 projects, 14 innovative drug products are in the clinical research stage, including 6 key registration and phase III clinical trials, 3 phase II clinical trials, 4 phase i clinical trials, and 3 ind acceptance.
Figure three: The company is researching pipeline charts
The company currently focuses on three major areas of tumor diseases, central nervous system diseases and autoimmune diseases, and its differentiated pipeline layout and self-developed + bd two-wheel drive R & D system have created efficient R&D efficiency.
In the field of anti-tumor, Simcere Pharmaceutical's strategy is to focus on tumor immunotherapy, explore tumor-driven gene abnormalities and synthetic lethal mechanisms, and focus on targets and drugs with potential and differentiated competitiveness. At present, the company has a number of drugs in this field to reach the clinical stage III, and the drugs in the phase I and clinical application stages are targeting or selecting the direction of the current cutting-edge research direction, and from the perspective of progress, the company is also in a leading position in the field.
In the field of central nervous system diseases, the company takes stroke as the center, gradually realizes single disease, full course coverage, and gradually expands to multiple sub-areas, such as Alzheimer's disease, cerebral edema, etc.; in this field, Simcere Pharmaceutical has both products that have been listed first ®, and there are potential drugs such as sublingual tablets, sim0307 and sim0339 that are in the clinical stage.
In the field of autoimmune diseases, Simcere Pharmaceutical focuses on the indications with a large number of patients and high demand, and is committed to breaking through the limitations of existing treatment methods, while it is also actively expanding high-potential markets that have not yet received sufficient attention, such as Sjögren's syndrome.
Thanks to the company's strong R & D team, under the self-development + bd two-wheel drive, Simcere Pharmaceutical will play its team's R & D innovation ability to the extreme, the company's self-development pipeline progressed rapidly, in addition to the recent three ind mentioned above, it is expected that the next year will also enter the ind stage, will form a strong support for the company's long-term development.
With the listing and volume of the company's new products, the revenue proportion of Simcere Pharmaceutical's innovative drugs has reached a new high, reaching 57.6% in the first half of 2021, far exceeding the average of 13% of the industry's similar categories, and the company's innovative research and development capabilities have gradually been realized. At the same time, based on the company's perfect layout and efficient R&D efficiency in three major areas, the company's innovative drug business has formed a wave-like development trend, the faster-progress products are about to enter the harvest period, and drugs with greater potential have also begun to enter the clinical stage.
From the perspective of market performance, with the deepening of investors' understanding of the company and the continuous improvement of expectations, the company's valuation has gradually repaired, and the stock price has risen by more than 20% since the lowest point of 6.45 Hong Kong dollars in the previous period. With the continuous release of the company's innovative research and development capabilities, the company's growth will be further reflected, and the future can continue to pay attention.
This article originated from Grand Gateway
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