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SHENZHEN, China, April 30, 2024 /PRNewswire/ -- Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) announced that the company's lead innovative product Chidamide (Epidaza®) , an oral subtype-selective histone deacetylase (HDAC) inhibitor, combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), has been officially approved by the National Medical Products Administration (NMPA) for treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) with positive MYC and BCL2 expression. Up to now, Chidamide has been approved for multiple indications globally. (For more information, please review the global commercialization situation).

Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma, with approximately 30000 new cases occurring annually in China. Clinical diagnosis and treatment guidelines and consensus both domestically and internationally recommend the R-CHOP regimen as the standard first-line treatment for DLBCL. However, about one-third or more of patients in the overall population still experience ineffective or early recurrence of first-line R-CHOP treatment. Meanwhile, approximately 30% of patients with DLBCL exhibit simultaneous overexpression of MYC/BCL2 protein (referred to as "double expression" lymphoma, DEL), and their efficacy and prognosis after R-CHOP treatment are significantly lower than those of non double expression patients. Therefore, how to combine new drugs based on R-CHOP regimen to provide a more effective and safer treatment to our patients is a significant unmet medical need.

The approval of this new indication is based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial DEB trial (NCT04231448). The DEB trial is the first Phase III registered clinical study in the world as first line treatment of MYC/BCL2 dual expression diffuse large B-cell lymphoma. This trial is to evaluate the efficacy and safety of Chidamide combined with R-CHOP compared to R-CHOP in primary treatment and MYC/BCL2 dual expression DLBCL subjects. Based on the interim analysis conducted by the Independent Data Monitoring Committee (iDMC), the efficacy and safety indicators set by the protocol were achieved. Compared with the R-CHOP regimen, the Chidamide combination regimen significantly improved the complete response rate (CRR) of the study's key secondary endpoint, and the study's primary endpoint, event free survival (EFS), also showed a clear trend of benefit. The experimental safety profile is consistent with known risks, and no new significant safety signals were found. The results of the interim analysis of the DEB Phase III study were selected as the Late breaking Abstract (LBA) for the American Society of Clinical Oncology (ASCO) Annual Meeting on April 24, 2024.

Dr. Xianping Lu, Chairman and General Manager of Chipscreen Biosciences, stated, "The classic R-CHOP regimen has been used as a first-line treatment for diffuse large B-cell lymphoma (DLBCL) for nearly 20 years, but its therapeutic effect is not satisfactory in populations with dual expression of BCL2 and MYC proteins. The combination of Chidamide and R-CHOP is the world's first phase 3 registered clinical study that focuses on first line therapy of dual expressed DLBCL, and also the world's first R-CHOP improvement study with significant benefits in complete remission rate. We believe that the approval of the new indication will bring new hope and better survival benefits to patients."

About Chidamide (Epidaza®)

Chidamide (Tucidinostat, Trade name: Epidaza®), a Class 1.1 innovative drug, is a novel molecular entity with global patent protection and the first marketed product developed independently by Chipscreen Biosciences. The first original chemical new drug approved in China, Chidamide is also the first oral subtype-selective histone deacetylase (HDAC) inhibitor in the world, Since its approval in China in December 2014 for the treatment of peripheral T-cell lymphoma, Chidamide has achieved significant commercialization worldwide and continuously explored new indications.

Global commercialization situation:

• In December 2014, Chidamide was approved for use in patients with recurrent or refractory peripheral T-cell lymphoma (PTCL) in China;
• In November 2019, Chidamide was approved to combine aromatase inhibitors to treat locally advanced or metastatic breast cancer patients with estrogen receptor positive, human epidermal growth factor receptor-2 negative, postmenopausal, and endocrine therapy relapse or progress in China;
• In June 2021, Chidamide was approved for monotherapy in the treatment of recurrent or refractory (R/R) adult T-cell leukemia (ATL) in Japan;
• In December 2021, Chidamide was approved for monotherapy for recurrent or refractory (R/R) peripheral T-cell lymphoma (PTCL) in Japan;
• In March 2023, Chidamide was approved to be used for postmenopausal women with locally advanced or metastatic breast cancer who are hormone receptor positive, type II human epidermal growth factor receptor (HER2) negative, and relapse or worsen after endocrine therapy (in combination with exemestane) in Taiwan, China;
• In April 30, 2024, Chidamide was approved to use in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) for previously untreated diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression in China.

Global exploration of other indications:

• In addition to ongoing global multicenter phase III clinical trial for the first-line treatment of melanoma in comniation with Opdivo, Chidamide is also conducting multiple clinical trials in China and internationally in  combination with different anti-tumor immunotherapies.
• In November 2023, the Phase II clinical trial of the first-line treatment of non-small cell lung cancer with Chidamide combined with Tislelizumab was completed and enrolled.
• On March 4, 2024, Professor Ruihua Xu and Professor Feng Wang from the Cancer Prevention and Treatment Center of Sun Yat sen University led the research on CAPAbility-01, which was published on  the world's top academic journal Nature Medicine (IF=82.9). As one of the most valuable sub journals under Nature, the publication of Nature Medicine reflects the academic authority's recognition of CAPAbility-01 research. This study indicates that for patients with microsatellite stable/mismatched repair function intact (MSS/pMMR) type metastatic colorectal cancer (mCRC), a three drug regimen led by Chidamide (Chidamide+sintilimab antibody+bevacizumab) for third line and above treatment, with an 18 week PFS rate of 64.0%, an ORR of 44.0%, and a median PFS of 7.3 months, is considered a promising treatment option for MSS/pMMR advanced CRC patients.
• On April 24, 2024, an abstract entitled "Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study" was selected the American Society of Clinical Oncology (ASCO) LBA list for the 2024 ASCO, which submitted by Professor Weili Zhao's team from Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine

About Chipscreen

Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Our complete industry chain that covers early exploratory discovery through commercialization allows us to provide innovative Chinese drugs for patients worldwide.

With a global development strategy based on early-stage research in China, Chipscreen Biosciences has leveraged the top scientists and teams with extensive experience in related fields from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center to create an integrated technology platform based on AI-driven design and chemical genomics, which spanned the whole process from basic science to clinical translation. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, we have marketed two drugs for threeindications in Mainland China, two indications in Japan, and one indication in Taiwan, China. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals.

Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 660 invention patents in China and worldwide, with over 180 granted.

SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Contacts 

Chipscreen Biosciences (United State) Limited
Stephen Xue

General Manager
stephen_xue@chipscreen.com

Shenzhen Chipscreen Biosciences
Jiawen Zhang
Business Development Director, Based in Shanghai
Zhangjiawen@chipscreen.com

SHENZHEN, China, March 18, 2024 /PRNewswire/ -- On March 18, 2024, Shenzhen chipscreen biosciences Co., Ltd. (hereinafter referred to as "chipscreen biosciences", stock code: 688321. SH) announced that the Phase II clinical trial (CGZ203 study) of chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) was successfully completed with data cleaning and database locking on February 22, 2024. The primary efficacy endpoint of the trial has been achieved, and further data analysis is currently underway.

The incidence of non-alcoholic fatty liver disease (NAFLD) or metabolic associated fatty liver disease (MAFLD) in the general population of China exceeds 25%, of which about 25% will progress to NASH, and this proportion is even higher in patients with metabolic syndrome. Currently, there is only one thyroid receptor β (TRβ) agonist approved worldwide.

The CGZ203 study is a randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial aimed to evaluate the safety and preliminary efficacy of chiglitazar monotherapy in diagnosed NASH patients. The CGZ203 study was led by Beijing Friendship Hospital affiliated to Capital Medical University and conducted in 24 clinical sites nationwide.

Preliminary results showed that both dose groups of chiglitazar produced significant and dose-dependent reductions at the primary efficacy endpoint (the proportion of changes from baseline in liver fat content evaluated by MRI-PDFF after 18 weeks of treatment), compared to placebo control group. In terms of secondary efficacy endpoints such as the proportion of patients with an over 30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis and so on, both dose groups of chiglitazar also showed significant or dose-dependent trend of improvements. The overall safety is good.

The detailed research results will be presented on an upcoming scientific conference or in research article.

About Chiglitazar:

Chiglitazar (Carfloglitazar) is a novel peroxisome proliferator activation related receptor (PPAR) pan-agonist, independently discovered and developed by Shenzhen chipscreen biosciences with global patent protection. It was firstly approved in China in October 2021, for clinical treatment of type 2 diabetes patients who cannot be effectively controlled by exercise and diet control. It is also the first approved PPAR pan-agonist in the world.

Chiglitazar has already completed a phase III trial of combination with metformin to treat type 2 diabetes patients (RECAM study) and the current phase II trial in NASH patients (CGZ203) in China.

About CGZ203:

CGZ203 is an exploratory phase II trial aimed at treating NASH patients. It was designed as a randomized, double-blind, placebo-controlled multicenter clinical trial. The clinically diagnosed NASH patients were randomly enrolled in a ratio of 2:2:1 to receive oral administration of chiglitazar 48 mg, 64 mg, and placebo once a day respectively, with a treatment period of 18 weeks. The primary efficacy endpoint is the percentage of changes from baseline in liver fat content (LFC) evaluated by magnetic resonance proton density fat fraction (MRI-PDFF) after 18 weeks of treatment. Secondary endpoints include the absolute value of LFC changes, the proportion of people with a decrease of more than 30% in LFC, changes in other non-invasive indicators of liver cell damage, inflammation, and fibrosis, and the patient safety during the trial period.

About Chipscreen:

Shenzhen Chipscreen biosciences is a modern biopharmaceutical enterprise founded by a senior overseas Returnees team in 2001. The company specializes in the discovery and development of original new molecular entity drugs, focus on five major disease fields of cancer, metabolic diseases, autoimmune diseases, central nervous system diseases.

With the independently created "integrated drug discovery and early evaluation platform based on chemical genomics", chipscreen has developed multiple original new drugs including two marketed products Chidamide (Tucidinostat) and Chiglitazar (Carfloglitazar), several clinical stage drug candidates Chiauranib (phase III), CS12192 (phase I), CS23546 (phase I), and CS32582 (Phase I).

Till now, chipscreen has established a global industrial layout consisting of its headquarters, R&D center, a wholly-owned subsidiary of GMP production base (Shenzhen chipscreen Pharmaceutical Co., Ltd.) in Shenzhen, a wholly-owned subsidiary of its Chengdu regional headquarters/R&D center/innovative drug production base (Chengdu chipscreen Pharmaceutical Co., Ltd.) in Chengdu, Beijing branch (clinical research center), Shanghai branch (commercial center), and chipscreen Biosciences (USA) Co., Ltd.

Chipscreen is one of the first batch of national "innovative drug incubation bases" and a national high-tech enterprise, independently undertakes dozens of national "863", "10th/11th/12th/13th five year plan of major scientific and technological special projects", and "major new drug creation" projects. A total of over 600 domestic and foreign invention patents have been applied, and over 160 have been authorized.

SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Contacts 

Chipscreen Biosciences (United State) Limited
Stephen Xue

General Manager
stephen_xue@chipscreen.com

Shenzhen Chipscreen Biosciences
Jiawen Zhang
Business Development Director, Based in Shanghai
Zhangjiawen@chipscreen.com

CHENGDU, China, Jan. 16, 2024 /PRNewswire/ -- Chengdu Chipscreen NewWay Biosciences Co., Ltd. (NewWay) announced that on January 5, 2024, the dosing of the first patient for a phase I clinical trial of a PD-1/CD40 bispecific antibody (bsAb), NWY001, at Sun Yat-Sen University Cancer Center in China, the trial-leading institution. The trial is a multi-center, non-randomized, open-label, multi-dose phase I clinical trial designed to evaluate the safety, tolerability, preliminary efficacy, pharmacokinetic properties, and potential biomarkers associated with NWY001 treatment in patients with advanced solid tumors.

NWY001 is world's first PD-1/CD40 bispecific antibody entering clinical study. Mechanistically, the bsAb targets two targets synergistically and can activate the CD40 pathway in a PD-1 dependent manner, reducing the potential toxicity commonly associated with CD40 agonistic monoclonal antibody (mAb). It is expected that this bsAb can transform "cold" tumors into "hot" tumors, thereby increasing cancer patients' sensitivity to PD-(L)1 immune checkpoint inhibitors, especially PD-(L)1 antibody resistant cancer patients.

Dr. Bin Liu, Scientific Director of Chipscreen NewWay, said:

"Dosing of the first patient marks a significant milestone for the clinical development of NWY001. Its unique mechanism is expected to circumvent the ineffectiveness or toxicity caused by PD-(L)1 immune checkpoint inhibitor monotherapy, CD40 agonists, or their combination therapy, therefore benefiting more cancer patients. We thank the experts at Sun Yat-Sen University Cancer Center for their great support, the clinical and related teams at Chipscreen for their efforts, and the patients enrolled in this NWY001 clinical trial and their families."

February 27th, 2023 - Biocytogen Pharmaceuticals (Beijing) Co., Ltd. announced that its wholly owned subsidiary, Eucure (Beijing) Biopharma Co., Ltd., has reached an exclusive licensing agreement with Chipscreen NewWay Biosciences, a holding subsidiary of Shenzhen Chipscreen Biosciences Co., Ltd. ("Chipscreen Biosciences", SSE: 688321) for the clinical development and commercialization of bispecific antibody YH008 (NWY001) in Greater China (including Mainland China, Hong Kong, Macau and Taiwan).

About Chipscreen NewWay

Chipscreen Newway, affiliated with Chipscreen, is an innovative and R&D-driven biotech company dedicated to developing large molecules and other novel therapeutic modalities, including antibodies/ADC-centered large molecules, and nucleic acid drugs.

It develops innovative drugs that meet clinical needs and novel mechanisms of action in multiple therapeutic areas such as oncology and autoimmunity while providing patients with innovative mechanisms and globally leading-based new therapeutic approaches and options.

Chipscreen Newway has built a large molecular R&D center of over 3,000 square meters in Chengdu Hi-Tech Zone and has established an experienced antibody and ADC R&D team from the discovery to the early process development, with a number of in-house and cooperation projects in continuous and rapid advancements.

About Chipscreen

Chipscreen is a modern biopharmaceutical company founded in 2001 by a seasoned team of professionals who returned to China after studying in the United States. The company specializes in the development of original new molecular entity drugs and is committed to providing innovative drugs with revolutionary therapeutic effects that are affordable for patients worldwide and are in high clinical demand.

Leveraging its independently created state-of-the-art "Chemical Genomics-Based Integrated Drug Discovery and Early Evaluation Platform", Chipscreen has developed multiple original drug product lines in five significant disease areas, including oncology, metabolic diseases, autoimmune diseases, central nervous system disorders, and antiviral therapies. These product lines include chidamide (Tucidinostat marketed), chiglitazar (Carfloglitazar marketed), chiauranib (Ibcasertib in pivotal phase III clinical trial), and CS12192 (phase I clinical trial currently underway).

Currently, Chipscreen has established a global presence through its headquarters and R&D center in Shenzhen, with a wholly-owned subsidiary "Shenzhen Chipscreen Pharmaceuticals Co., Ltd." serving as a GMP production base. Additionally, it has a regional headquarters/R&D center/innovative drug production base - "Chengdu Chipscreen Pharmaceuticals Co., Ltd." focusing on the field of small-molecule innovative drugs, and a subsidiary "Chengdu Chipscreen Newway Biosciences Co., Ltd." dedicated to the development of large molecules and other novel therapeutic technologies. The company also maintains branches in Beijing (Clinical Research Center) and Shanghai (Business Center). Furthermore, Chipscreen extends its global footprint, with Chipscreen Biosciences (United States) Limited set up for global clinic development in the United States, embodying a comprehensive globalization strategy.

About Biocytogen

Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice® (RenMab™/RenLite®/RenNano®/RenTCR-mimic™) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2023, 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company's sub-brand, BioMice™, along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg).

Source: Shenzhen Chipscreen Biosciences Co., Ltd. 

Contacts 

Chipscreen Biosciences (United State) Limited
Stephen Xue

General Manager
stephen_xue@chipscreen.com

Shenzhen Chipscreen Biosciences
Jiawen Zhang
Business Development Director, Based in Shanghai
Zhangjiawen@chipscreen.com

New Jersey, January 10th, 2024--Shenzhen Chipscreen Biosciences is a China headquartered biopharmaceutical company developing and marketing novel drugs based on its unique technology of Chemical Genomics Drug discovery platform. Chipscreen Biosciences (United States) LTD was established on Oct 16, 2020. Registered in Newark, Delaware but with its offices located at Somerset, New Jersey. Today announces that the phase 1b/2 Single-Arm, Open Label, Dose-Escalation, Multicenter Study which aims to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of advanced solid Malignant Tumors and Relapse/Refractory Small Cell Lung Cancer was completed.  The Safety Review Committee (SRC) met on January 10th, 2024, to discuss, cohort 2, there was no DLT, or concerns reported therefore all members unanimously agreed to continue with the next cohort. 

Lung cancer is the leading cause of cancer mortality worldwide, with an estimated 2.1 million new cases and 1.8 million deaths in 2018. SCLC comprises an estimated 250,000 new cases and at least 200,000 deaths globally each year. SCLC is most prevalent in men but the proportion of cases in women compared to men has risen worldwide over the past 50 years. SCLC represents about 15% of all lung cancers and is marked by an exceptionally high proliferative rate, strong predilection for early metastasis, and poor prognosis. SCLC is strongly associated with exposure to tobacco carcinogens. Most patients have metastatic disease at diagnosis, with only one-third having earlier-stage disease that is amenable to potentially curative multimodality therapy. 

Dr. Xianping Lu, Founder, Chairman and CEO of Chipscreen Biosciences, says:

Medicines are unique products related to human lives. They should be based on science, rather than political, religious, or commercial interests. 

Chiauranib is a novel oral multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases (VEGFR2, VEGFR1, VEGFR3, PDGFRα, and c-Kit), mitosis-related kinase Aurora B, and chronic inflammation-related kinase CSF-1R. 

Currently, Chipscreen US is running a phase 1b/2 Single-Arm, Open Label, Dose-Escalation, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Chiauranib for the Treatment of Advanced solid Malignant Tumors and Relapse/Refractory Small Cell Lung Cancer.

The study includes two (2) stages:

Phase 1b: Dose-Escalation Stage (Single-Dose and Consecutive-Dose Periods)

Phase 2: The recommended Phase 2 dose (RP2D) will be given to all patients enrolled in this phase once daily on a 28-day cycle. 

Cohort 3, of the phase 1b study has started.

Contact

Chipscreen Biosciences (United States) Limited

Stephen Xue

General Manager
stephen_xue@chipscreen.com

SHENZHEN, China, Nov. 2, 2023 /PRNewswire/ -- On Oct. 31, 2023, Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as "Chipscreen" and with stock code 688321.SH) received the "Drug Clinical Trial Approval Notice" issued by the National Medical Products Administration ("NMPA") through its wholly-owned subsidiary, Chengdu Chipscreen Pharmaceutical Co., Ltd. The notice grants approval for conducting clinical trials of CS32582 capsules in the treatment of psoriasis.

CS32582 is a novel small molecule and highly selective allosteric inhibitor of Tyrosine Kinase 2 (TYK2) independently developed by Chipscreen. It achieves selective inhibition of TYK2 by specifically binding to its regulatory pseudokinase JH2 domain. Importantly, CS32582 will not inhibit the JAK1, JAK2 and JAK3 of the same family at therapeutic doses. This characteristic ensures both therapeutic efficacy and a favorable safety profile.

CS32582 effectively inhibits TYK2, thereby blocking downstream signaling pathways mediated by cytokines such as interleukin (IL)-23, IL-12, and interferon (IFN) type I. This action contributes to its therapeutic effect in autoimmune diseases like psoriasis. Preclinical studies have demonstrated its significant therapeutic efficacy in mouse models of psoriasis.

About Psoriasis

Psoriasis is an immune-mediated, chronic, relapsing, inflammatory, and systemic disease induced by the combined effects of genetics and the environment. It is also associated with several potential comorbidities that can impact the patients' health, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, and depression, significantly affecting the patients' quality of life[1].

Traditional systemic oral therapies are non-targeted drugs, often associated with undesired side effects and long-term safety concerns. Striking a balance between benefits and risks remains a significant challenge, and there is an urgent need for safe and effective new targeted oral therapies[2].

Small molecule targeted oral medications offer superior efficacy and safety compared to traditional systemic therapies. Currently, the TYK2 inhibitor Deucravacitinib tablet is the only globally approved oral medication for treating adult patients with moderate to severe plaque psoriasis who are candidates for systemic treatment or phototherapy[3].

Now, CS32582 holds potential therapeutic value for autoimmune diseases like psoriasis that are mediated by cytokines such as IL-23, IL-12, and type I IFN. It is expected to offer patients a treatment choice with better efficacy and safety compared to existing clinical drugs.

About Chipscreen

Chipscreen is a modern biopharmaceutical company founded in 2001 by a seasoned team of professionals who returned to China after studying in the United States. The company specializes in the development of original new molecular entity drugs and is committed to providing innovative drugs with revolutionary therapeutic effects that are affordable for patients worldwide and are in high clinical demand.

Leveraging its independently created state-of-the-art "Chemical Genomics-Based Integrated Drug Discovery and Early Evaluation Platform", Chipscreen has developed multiple original drug product lines in five significant disease areas, including oncology, metabolic diseases, autoimmune diseases, central nervous system disorders, and antiviral therapies. These product lines include chidamide ( Tucidinostat marketed), chiglitazar ( Carfloglitazar marketed), chiauranib (Ibcasertib in pivotal phase III clinical trial), and CS12192 (phase I clinical trial currently underway).

Currently, Chipscreen has established a global presence through its headquarters and R&D center in Shenzhen, with a wholly-owned subsidiary "Shenzhen Chipscreen Pharmaceuticals Co., Ltd." serving as a GMP production base. Additionally, it has a regional headquarters/R&D center/innovative drug production base - "Chengdu Chipscreen Pharmaceuticals Co., Ltd." focusing on the field of small-molecule innovative drugs, and a subsidiary "Chengdu Chipscreen Newway Biosciences Co., Ltd." dedicated to the development of large molecules and other novel therapeutic technologies. The company also maintains branches in Beijing (Clinical Research Center) and Shanghai (Business Center). Furthermore, Chipscreen extends its global footprint, with Chipscreen Biosciences (United States) Limited set up for global clinic development in the United States, embodying a comprehensive globalization strategy.

REFERENCES

[1] Chinese Medical Association, Chinese Medical Journal, Dermatology Branch of Chinese Medical Association, etc. Guidelines for the Diagnosis and Treatment of Psoriasis (2022) [J]. Chinese Journal of General Practitioners, 2022, 21(8):705-714.
[2] Martin G. Novel Therapies in Plaque Psoriasis: A Review of Tyrosine Kinase 2 Inhibitors[J]. Dermatol Ther (Heidelb). 2023 Feb;13(2):417-435.
[3] FDA. SOTYKTU (deucravacitinib) tablets Label. 2022.9.

SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Contacts 

Chipscreen Biosciences (United State) Limited
Stephen Xue

General Manager
stephen_xue@chipscreen.com

Shenzhen Chipscreen Biosciences
Jiawen Zhang
Business Development Director, Based in Shanghai
Zhangjiawen@chipscreen.com

August 29, 2022 – Shenzhen Chipscreen Biosciences CO., LTD. (hereinafter referred to as: CHIPSCREEN), a China-headquartered biopharmaceutical company, announces that the first patient was enrolled in the Clinical Trial Completion Project (NCT05271292) to proceed with a Phase 1b/2 clinical trial of Chiauranib/CS2164 (Ibcasertib), a potential treatment for multiple oncological indications including Small Cell Lung Cancer (SCLC) in the United States. The clinical study is a single-arm, open, dose-escalating, phase 1b clinical trial that is focused on exploring patient safety, tolerability, and pharmacokinetics. April 16, 2021, Shenzhen Chipscreen Biosciences received a Phase 1b/2 clinical trial of Chiauranib/CS2164 STUDY MAY PROCEED LETTER from the US Food and Drug Administration (FDA).

Chiauranib, a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor, was developed by Chipscreen Biosciences specifically to address drug resistance. Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis, induces tumor cell mitosis by inhibiting alternative lengthening of telomerase pathway and Myc gene dysfunctions, and modulates the tumor immune microenvironment. With a favorable safety profile, Chiauranib has outperformed drugs of other target therapies in its pharmacodynamic activity in animal studies. 

At present, the company is developing Chiauranib in the global synchronization, and two pivotal phase III clinical trials for the treatment of small cell lung cancer and the combination of paclitaxel for the treatment of ovarian cancer, as well as a few phase II trials for multiple other indications are currently on going in China, and the clinical research of small cell lung cancer and ovarian cancer has been designated by the CDE (Center for Drug Evaluation of the State Drug Administration of PRC) into the "breakthrough treatment".

Chipscreen was founded in March 2001 by a group of senior scientists who returned from the United States.  The headquarters is in Shenzhen, China with two R&D centers and several branches. The branches are Shenzhen Chipscreen Pharmaceutical Co., Ltd. (GMP production base), Chengdu Chipscreen Pharmaceutical Co., Ltd, the subsidiary Chengdu Chipscreen New Field Biotechnology Co., Ltd. (novel therapeutic technologies), Beijing Branch (Clinical Research Center) and Shanghai Branch (Commercial Center). Chipscreen Bioscience (US) Ltd was established in October 2020 for pursuing global development of the drug candidates originated from China and started its operation in New Jersey on April 2021. 

Chipscreen focuses on developing innovative drugs with new mechanisms of action (MOA) for the treatment of human diseases to provide patients with affordable, efficacious drugs to meet their clinical needs. Through the international advanced "Integrated Drug Discovery and Early Evaluation Platform Based on Chemical Genomics", Chipscreen has developed several original innovative drug product lines for the five major diseases including cancer, metabolic diseases, autoimmune disorders, central nervous system disorders, and antivirals. Several original innovative drug product lines have been developed, including Chidamide (marketed, Tucidinostat), Chiglitazar (marketed, Carfloglitazar), Chiauranib (has entered clinical phase III), and CS12192 (phase I clinical trials are underway). 

Contacts 

Chipscreen Biosciences (United State) Limited
Stephen Xue

General Manager
stephen_xue@chipscreen.com

Shenzhen Chipscreen Biosciences
Jiawen Zhang
Business Development Director, Based in Shanghai
Zhangjiawen@chipscreen.com