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Xiamen Spacegen Co., Ltd., Xiamen (2026)

26/12/2025

DNA mismatch repair (MMR) is a crucial mechanism for correcting DNA replication errors and maintaining genomic stability. It recognizes and repairs mismatched base pairs. This process involves DNA binding, strand excision, and resynthesis by DNA polymerases. MMR is also involved in atypical functions such as oxidative DNA damage repair and immunoglobulin diversification.Defects in MMR genes lead to microsatellite instability (MSI), a characteristic of some cancers, particularly prevalent in solid tumors.

MMR is a well - established mechanism for maintaining genomic stability. Beyond its typical role in correcting DNA replication errors, new evidence highlights its involvement in other biological processes, such as regulating immune responses and influencing tumor progression. These atypical functions underscore the role of MMR in cancer biology, especially in less common cancers.

Future efforts should focus on refining biomarker - driven patient selection (e.g., MGMT methylation, MSH6 mutations, ctDNA monitoring), optimizing combination regimens (dual checkpoint with monotherapy), and extending MMR alteration strategies to a broader range of "cold" tumors. By integrating molecular mechanisms and clinical experience, this field can tailor immunotherapeutic approaches that leverage MMR dynamics to maximize durable anti - tumor immunity.

11/12/2025

A New Chapter in Medical Insurance: SpaceGen Supports Precision Treatment of Breast Cancer

On December 7, 2025, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security issued the Catalogue of National Basic Medical Insurance, Maternity Insurance and Work - related Injury Insurance Drugs and the Catalogue of Innovative Drugs for Commercial Health Insurance (2025) [1], marking that the construction of China's multi - level medical security system had entered a new stage. At the same time, the guarantee of "covering the basics" and "supplementing the high - end" was realized.

Among them, the most remarkable aspect is the inclusion of two new drugs that were just approved for marketing this year. Both of these drugs fall under Class B reimbursement.

Inavolisib: It is limited for use in combination with Palbociclib and Fulvestrant, targeting adult patients with locally advanced or metastatic breast cancer who are resistant to endocrine therapy (including relapse during or after adjuvant endocrine therapy), have a PIK3CA mutation, are hormone receptor (HR) positive, and human epidermal growth factor receptor 2 (HER2) negative [1].

Capivasertib: It is limited to adult patients with locally advanced or metastatic breast cancer who have received at least one endocrine therapy at the metastatic stage, or who are hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and have one or more changes in PIK3CA/AKT1/PTEN during adjuvant therapy or within 12 months after adjuvant therapy [1].

These two drugs were approved in March and April this year, respectively, and were included in the list of medical insurance drugs in China in the same year. This not only reflects the urgent need for precise medical care for breast cancer patients but also demonstrates the advancement of China's medical system.

Detection requirement

According to the indications in the medical insurance catalogue, Capivasertib requires the detection of three genes: PIK3CA, PTEN, and AKT1. First, we should pay attention to the PIK3CA gene. The mutation of PIK3CA occurs in 35% - 40% of HR+ and HER2- breast cancers, and it encodes the catalytic subunit p110α of PI3Kα, which is the core of the PI3K - AKT - mTOR signaling pathway. There are many mutation sites of PIK3CA in breast cancer, and 70% - 80% of them occur in E545K, E542K, and exon 9. According to the mutation detection of the PIK3CA gene in different clinical experiments, more sites of PIK3CA need to be detected. Although the consensus mentions that PCR or NGS methodology can be used, NGS may be a better detection scheme from the perspective of health economics.

The mutation rate of AKT1 in Chinese breast cancer patients is about 6% (up to 12.1% in the Luminal A type). The most common mutation site is E17K, and the PTEN inactivation mutation rate is about 8%. Among them, the PTEN deletion rate is as high as 22% - 47% in HER - 2+ Trastuzumab - resistant breast cancer, which can independently predict the curative effect and poor prognosis of Everolimus. PTEN is a tumor - suppressor gene, and the common mutation types related to functional loss are functional inactivation mutation, copy number loss, and rearrangement [3].

SpaceGen-assisted Precise Treatment of Breast Cancer

SpaceGen is deeply engaged in the field of precise tumor detection and is committed to providing a comprehensive detection scheme for individualized and precise medical detection of tumors. At present, SpaceGen's breast - cancer - related products can meet the different needs of patients. In addition to the PAM pathway, biomarkers such as BRCA1/2 also have related indications in the medical insurance catalogue. For breast - cancer - related targets, SpaceGen can achieve comprehensive coverage and precise detection, effectively reduce missed detections, and comprehensively contribute to a new chapter in the precise treatment of breast cancer.

References
[1] https://www.nhsa.gov.cn/art/2025/12/7/art_104_18970.html
[2] China breast cancer PIK3CA gene mutation detection expert consensus (2025 edition)
[3] Clinical Practice Guidelines for Molecular Pathological Detection of Breast Cancer (2025 Edition)

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02/12/2025

Within the cellular realm, a DNA “proofreading mechanism” (DNA Mismatch Repair, MMR) functions incessantly to guarantee the precise replication of genetic information during cell division. When this mechanism malfunctions, errors in DNA replication accumulate, culminating in a mismatch repair defect (DMMR). DMMR can induce alterations in microsatellites, giving rise to high microsatellite instability (MSI - H). The resultant cancer, namely the MSI - H/DMMR tumor, which was once refractory, has now emerged as the “favored subject” of contemporary immunotherapy.

Presently, international guidelines advocate for routine MSI/MMR testing in newly diagnosed patients with colorectal, endometrial, and gastric cancer. Although immune checkpoint inhibitors (ICIs) have achieved notable success, certain patients exhibit no therapeutic efficacy or develop drug resistance. Future research endeavors encompass the identification of more accurate predictive biomarkers, the exploration of combination strategies of ICIs with other therapeutic modalities to overcome drug resistance, and the optimization of novel adjuvant therapies in early - stage diseases for organ preservation and high - quality long - term survival.

The progression from fundamental biological discoveries regarding microsatellite instability - high (MSI - H)/mismatch repair deficiency (dMMR) to the revision of cancer treatment guidelines in clinical practice serves as an exemplary paradigm of the advancement of precision medicine and tumor immunology. It demonstrates that a comprehensive understanding of the intrinsic mechanisms of cancer will provide a powerful approach to overcome it.

28/11/2025

With the rapid development of medical technology, genetic testing has become an indispensable tool in the diagnosis and treatment of gynecological tumors. Despite its significant value, the application of genetic testing faces numerous challenges:

1. Low detection rates: For instance, the detection rate of homologous recombination deficiency (HRD) in ovarian cancer is only 30%. This situation calls for enhanced patient awareness.
2. Technical standardization: Different detection methods, such as immunohistochemistry (IHC), next - generation sequencing (NGS), and polymerase chain reaction (PCR), require further standardization.
3. Cost and accessibility issues: Genetic testing is costly, and medical insurance coverage needs improvement.
4. Data interpretation: It should be combined with clinical and pathological features to avoid over - interpretation or misinterpretation.
5. Multi - disciplinary collaboration: Collaboration among teams from gynecological oncology, pathology, and genetic counseling needs to be strengthened. Enhanced communication can help develop individualized treatment plans.
6. Ethical and privacy concerns: Strict data protection mechanisms should be established to prevent the leakage of genetic data.

In the future, with the development of liquid biopsy, multi - omics integration, and artificial intelligence, genetic testing will offer more precise and convenient guidance for clinical decision - making.

26/11/2025

Low expression of HER2 in Breast Cancer? Ultra-low expression?

Human epidermal growth factor receptor 2 (HER2) is a significant driver gene for breast cancer and an important target for targeted therapy. Currently, the expression level is primarily detected using immunohistochemistry (IHC), with in situ hybridization (FISH) technology employed to supplement the assessment of gene amplification status. This status can be categorized into two groups: HER2-positive and HER2-negative. Traditional targeted therapy against HER2 has been based mainly on HER2 positivity, which means only about 10-20% of breast cancer patients could benefit from such therapy. However, with the introduction of new antibody-drug conjugates (ADCs), the reliance on HER2 overexpression or gene amplification for traditional targeted anti-HER2 therapy has been disrupted. The conventional approach to anti-HER2 therapy has been redefined, and low expression (HER2 low) and ultra-low expression (HER2 ultralow) have been established as independent therapeutic targets for breast cancer. This development not only paves a new path for targeted therapy for traditionally "HER2-negative" patients but also broadens the population that can benefit from anti-HER2 therapy.

25/11/2025

Ovarian cancer is the deadliest form of gynecological cancer. Despite the introduction of Bevacizumab, standard chemotherapy protocols have largely remained the same, and most patients experience a relapse within the first two years after diagnosis. However, clinical practice has shown that the clinical benefits of PARP inhibitors are rapidly transforming treatment options for many ovarian cancer patients. Although various combination therapies may improve the efficacy of PARP inhibitors and overcome resistance mechanisms, identifying the patients most likely to benefit is essential. Therefore, it is crucial to identify sufficient predictive biomarkers to aid in accurate patient selection.

21/11/2025

The National Comprehensive Cancer Network (NCCN) released the latest "Clinical Practice Guidelines for Non-Small Cell Lung Cancer (NSCLC) Version 1.2026" on November 6, 2025. Compared to the 8th edition from 2025, it has undergone several significant updates. The new version of the guideline has achieved a "disruptive" update in the field of biomarker testing—from the definition of terms to the scope of testing, from technical paths to clinical linkage, it has comprehensively propelled the precise treatment of lung cancer into a new era of "full-spectrum testing."
For patients, genetic testing is no longer an "optional add-on," but the "key first step" that determines the treatment direction and survival time. For clinicians, the guideline provides a standardized testing path, avoiding treatment delays caused by incomplete testing and inappropriate timing. With the deepening understanding of tumor biology, in the future, genetic testing will not only identify single mutations but also comprehensively assess the molecular characteristics of tumors, including co-mutation situations, tumor heterogeneity, and evolutionary mechanisms, etc. Multidisciplinary collaboration is particularly important in the precise diagnosis and treatment of lung cancer. Facing the increasingly complex and variable biological characteristics of tumors, a single treatment approach is no longer sufficient to meet the challenges. Therefore, future precise treatment will be a cross-disciplinary collaborative effort, forming a more comprehensive and precise treatment system.

31/10/2025

Ovarian endometrioid cancer (OEC) is an epithelial malignant tumor of the o***y that exhibits a pathological morphology similar to endometrioid cancer of the endometrium. Its incidence rate ranks second only to high-grade serous cancer of the o***y, accounting for approximately 10% of all epithelial malignant tumors of the o***y. Common molecular mutations in OEC include those of the CTNNB1 and PTEN genes, as well as microsatellite instability (MSI). Other observed mutations are dMMR or POLE (15%), HRD (19%), BRCA1/2 mutations (6%), and PIK3CA mutations (31%).

Despite differences in the proportion of TCGA molecular subtypes and pathological features between ovarian endometrioid cancer and endometrial endometrioid cancer, the prognostic value of TCGA molecular subtypes is similar in both cancers. The extension of endometrial molecular classification to ovarian endometrioid cancer represents not only a technical advancement but also a paradigm shift in diagnosis and treatment. It moves our focus from the "location of the tumor" to the "molecular characteristics of the tumor," and from "uniform treatment" to "personalized treatment." For patients with OEC, this translates to increased hope for survival: early-stage patients can avoid overtreatment, advanced-stage patients can find precise treatment options, and young patients can maintain their fertility. For clinicians, this means a clearer diagnostic and treatment pathway, with each treatment decision backed by "molecular evidence."

💡Click to read: http://sspacegen.com/newsinfo.aspx?newsID=480&CateID=109&wb=3

31/10/2025

When discussing melanoma, it is often referred to as the "king of skin cancers." It is highly deceptive in its early stages, challenging to treat in advanced stages, and the risk of recurrence looms like a sword of Damocles over patients' heads. Traditional monitoring methods, such as imaging exams, frequently fail to detect abnormalities until the tumor has progressed to a certain stage, potentially narrowing the window for effective treatment.

Nevertheless, the advent of "liquid biopsy" technology, which involves the detection of circulating tumor DNA (ctDNA), is revolutionizing the diagnosis and treatment of melanoma. For patients with melanoma, the importance of ctDNA detection is twofold: it is crucial for monitoring minimal residual disease (MRD) in the early postoperative period and for assessing treatment efficacy in advanced stages. "Recurrence" is the root of fear, but "early detection" is the key to conquering it. The advent of ctDNA detection has made it possible to "anticipate recurrence," "monitor therapeutic effects in real-time," and "accurately stratify risks," offering new hope to patients.

💡Click to read: http://sspacegen.com/newsinfo.aspx?newsID=479&CateID=109&wb=3

15/10/2025

On October 11, 2025, according to official information released by the National Medical Products Administration (NMPA), Sacituzumab tirumotecan (sac-TMT), an antibody-drug conjugate (ADC) independently developed by Kelun Biotech, has been granted approval for a new indication, offering an additional therapeutic option for patients with advanced non-small cell lung cancer (NSCLC) in China. The newly approved indication is for the treatment of adult patients with locally advanced or metastatic NSCLC harboring epidermal growth factor receptor (EGFR) mutations who have experienced disease progression following prior therapy with EGFR tyrosine kinase inhibitors (EGFR-TKIs).

This is the third important indication approved by Sacituzumab in China after the back-line treatment for triple-negative breast cancer and specific non-small cell lung cancer, marking a further expansion of the application domain of this innovative domestic ADC drug in tumor treatment.This approval of the new indication provides a powerful alternative to chemotherapy for patients with EGFR mutant NSCLC after resistance to targeted drugs, and is expected to change the treatment pattern in this field and bring hope for the survival of more patients.

Click to read: http://sspacegen.com/newsinfo.aspx?newsID=477&CateID=109&wb=3

14/10/2025

What impact does HER2 status have on the treatment of gastric cancer? Traditionally, gastric cancer refers to an epithelial-derived malignant tumor that originates in the stomach. According to aggregated data from 2022, gastric cancer is the fifth most common malignant tumor in terms of both incidence and mortality worldwide, with an incidence rate of approximately 970,000 per year and a mortality rate of about 660,000 per year. Human epidermal growth factor receptor 2 (HER2) is a common and important target in gastric cancer. This article explores the gene characteristics that may affect tumor progression and treatment response in HER2-positive and HER2-negative gastric cancer patients, thereby providing new ideas and methods for personalized treatment of gastric cancer.

💡Click to read: http://sspacegen.com/newsinfo.aspx?newsID=476&CateID=109&wb=3

09/10/2025

Did you know? There is a "genetic cancer syndrome" that not only causes a family to successively suffer from colorectal cancer, but also makes women face a 60% risk of endometrial cancer and a 10% risk of ovarian cancer between the ages of 30 and 50. It is called Lynch syndrome, an often overlooked but potentially life-changing "invisible killer" that can be addressed through scientific means. What is Lynch syndrome?

Lynch syndrome is a hereditary cancer syndrome caused by mutations in mismatch repair genes (MMR), which leads to the failure of the DNA repair system, accumulation of cell mutations, and a sharply increased risk of cancer.
(1) Women need to be most vigilant: the risk of endometrial cancer (EC) is 40-60%, and the risk of ovarian cancer (OC) is 8-10%.
(2) Early onset of the disease: It occurs 10 to 20 years earlier than in the general population, and some may develop cancer as early as age 30.
(3) Family clustering: Several generations within a family may be affected, especially with colorectal cancer, endometrial cancer, and ovarian cancer.

Three sentences for every Lynch syndrome female.
（1）You are not destined to get cancer – scientific means can significantly reduce the risk.
(2) You are not alone in this fight - the genetic counseling clinic, gynecological oncology department, and psychological support are all by your side.
(3) You are not passively waiting - starting from today, actively monitor, actively consult, and actively make decisions.

Xiamen Spacegen Co., Ltd.

26/12/2025

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