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28 Mar, 2024
Genor Biopharma Releases Its Annual Results for 2023

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  • The NMPA has officially accepted the NDA for GB491 (Lerociclib) in combination with Fluvestran as the treatment of HR+/HER2 – locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy. Clinical on-site inspection was completed successfully. The differentiated advantages in efficacy and safety were demonstrated at the 2023 ASCO annual meeting and received international recognition.

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  • The efficacy data analysis of Phase III clinical trial for the first line breast cancer indication of GB491 (Lerociclib) reached the primary endpoint. The NMPA has officially accepted the NDA.

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  • The phase I/II clinical trial of GB261 has completed the dose-escalation, which demonstrated promising efficacy and a favorable safety profile. The preliminary clinical safety and efficacy results of phase I/II study has been presented at the annual meeting of the 65th American Society of Hematology (ASH).

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  • The phase I/II clinical trial of GB263T (EGFR/cMET/cMET, TsAb) has completed dose escalations of 1,680mg, radiographic remission was observed. The preliminary dose escalation results from a phase I/II study has been published on Molecular Cancer Therapeutics on American Association of Cancer Research (AACR) journal.

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  • The Company shared research data of two innovative drug molecules in the poster discussion session of the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in 2023.

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  • As of the end of December 2023, the cash balance of 1.165 billion RMB.

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Shanghai, China, March 28, 2024 – Genor Biopharma (Stock code: 6998.HK) announced today its 2023 annual financial results, business progress and other highlights in the past year.

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Dr. GUO Feng, Chairman of the Board and Chief Executive Officer, Genor Biopharma, said: “With the continuous implementation of the 'Focus, Optimization, Acceleration, Expansion' strategy, Genor Biopharma has run the business with high efficiency and sought opportunities for development. Lerociclib’s substantive progress of NDA for first - and second-line indications, the international recognitions of key products and early research results, and the active communication for business collaboration have laid a solid foundation for the company's sustainable development.”

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Core product garnered international recognition, clinical trials have advanced rapidly

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GB491 (Lerociclib) – The first-line and second-line NDA were officially accepted by the NMPA

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GB491 (Lerociclib), is a novel, potent, selective oral bioavailable CDK4/6 inhibitor co-developed by the Group and G1 Therapeutics, for use in combination with endocrine therapy in advanced breast cancer.

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Patient enrolment of the Phase III trials for both first and second line has been completed quickly via adaptive and seamless experiment design, scientific reference and data bridging, seamless registration strategy, and excellent execution.

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On 28 March 2023, the NMPA has officially accepted the NDA for GB491 (Lerociclib) in combination with Fluvestran as the treatment of HR+/HER2- locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy. Clinical on-site inspection was completed successfully in the second half of the year of 2023.

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GB491 (Lerociclib) has garnered international recognition at the 2023 ASCO annual meeting, which was successfully held in Chicago from 2 June to 6 June 2023:

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  • The research results of the LEONARDA-1 study were announced in the poster discussion session of the Metastatic Breast Cancer session with the title “Phase III randomized study of lerociclib plus fulvestrant in patients with HR+/HER2– locally advanced or metastatic breast cancer that has progressed on prior endocrine therapy”.

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  • The data from the Phase III clinical study of LEONARDA-1 were selected by ASCO for the ASCO Daily Release, which was published in the ASCO Daily News Column on its website on 25 May (EST) with the title “Lerociclib/Fulvestrant May Reduce Risk of Disease Progression in Advanced HR+/HER2- Breast Cancer”.

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  • The LEONARDA-1 research report and article cited the views of the lead author Prof. Binghe Xu, MD, PhD, the academician of the Chinese Academy of Engineering, the Head of Medical Oncology at Cancer Hospital affiliated with Chinese Academy of Medical Sciences;

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  • According to the efficacy and safety data demonstrated in the LEONARDA-1 research, GB491 (Lerociclib) has demonstrated superior efficacy, better safety and tolerability profile to patients with HR+/HER2– advanced breast cancer for whom prior endocrine therapy failed, providing a more reliable clinical option. It could become a preferred option among CDK4/6 inhibitors for refractory patients and patients with suboptimal recovery of myelosuppression after chemotherapy and suboptimal gastrointestinal/hepatic function or patients with poor tolerability.

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GB491 (Lerociclib) will create a new landscape for the treatment of HR+/HER2-advanced breast cancer.

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  • HR+/HER2– is the most common subtype of advanced breast cancer, and its treatment has entered the era of targeted therapy. Combination therapy with CDK4/6 inhibitors has been recommended in multiple guidelines as the preferred regimen for patients with advanced breast cancer following previous failed endocrine therapy.

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  • The innovative molecular structure with its unique pharmacokinetics / pharmacodynamics (PK/PD) has allowed for continuous oral administration of Lerociclib without the need for treatment breaks. It has achieved sustained target inhibition and antitumor effects while significantly reducing the common adverse effects of CDK4/6 inhibitors, such as severe myelosuppression and diarrhea.

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  • The LEONARDA-1 clinical study demonstrated that the combination therapy of Lerociclib with Fluvestran significantly reduced the risk of disease progression and death as compared to Fluvestran as a monotherapy. The investigator-assessed hazard-ratio (HR) was 0.451 and the Blinded Independent Central Review (BICR)-assessed HR was 0.353. The median progression-free survival (mPFS) (months) assessed by the investigator and BIRC were 11.07 vs. 5.49 and 11.93 vs. 5.75, respectively. Furthermore, the results of all predefined subgroups were consistent with the overall efficacy.

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  • The LEONARDA-1 clinical study showed that, in comparison with other marketed CDK4/6 inhibitors, Lerociclib demonstrated significant comprehensive advantages in terms of safety and tolerability profile with a low incidence rate of diarrhea at 19.7% (only grade 1/2), a relatively low percentage of grade 3/4 myelosuppression, and only a 5.1% incidence rate of grade 4 neutropenia.

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  • LEONARDA-1 has enrolled a high proportion of patients with poor prognosis, including patients with liver metastasis, treated with primary resistance, with 4 or more metastatic sites, received first-line chemotherapy at the advanced stage. The use of Lerociclib substantially improved the progression free survival (PFS) of the patients with poor prognosis, indicating a superior efficacy with advantages in terms of safety and tolerance profile and hence fully demonstrating the differentiation advantage of Lerociclib for clinical purposes.

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Phase III clinical trial for the first line treatment of advanced breast cancer indication of GB491 (Lerociclib) has completed patient enrolment. The efficacy data analysis has reached the primary endpoint.

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The Group has officially submitted the NDA to the NMPA for the first line breast cancer indication of GB491 (Lerociclib) on 28 February 2024. The NMPA has officially accepted the application on 13 March 2024.

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Currently, the Company is moving forward with commercial cooperation in respect of GB491 (Lerociclib). The transfer of technology for local manufacture of GB491 (Lerociclib) has also been initiated.

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GB261 (CD20/CD3, BsAb) - completed dose escalation in the phase I/II clinical trial, and demonstrated promising efficacy and a favorable safety profile

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GB261 (CD20/CD3, BsAb) is the first T-cell engager with low affinity to bind CD3 and has Fc functions (ADCC and CDC). GB261 (CD20/CD3, BsAb) significantly inhibits rituximab-resistant cancer cell proliferation in both in vitro assays and in vivo models; meanwhile with T-cell activation, GB261 (CD20/CD3, BsAb) induces less cytokine release compared with compound in the same class. Thus, GB261 (CD20/CD3, BsAb) is a highly potent bispecific therapeutic antibody for B cell malignancies. It has potential to be a better and safer T-cell engager with competitive advantages over other CD3/CD20 agents.

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Multiple GB261 (CD20/CD3, BsAb) phase I/II clinical study centers have been activated in Australia and China. We have obtained the preliminary clinical Proof of Concept (POC) data in the first-in-human (FIH) clinical trial of GB261 (CD20/CD3, BsAb) in Australia in 3mg dose-escalation cohort, indicating a good safety, pharmacokinetic profile and clinical antitumor activities.

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As at October 2023, the dose-escalation was completed in the phase I/II clinical trial of GB261 (CD20/CD3, BsAb), which demonstrated promising efficacy and a favorable safety profile. The anti-tumor activities were also seen in patients who have failed prior CD20/CD3 (mosunetuzumab), CAR-T, and CD3/CD19 therapies.

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At the annual meeting of the 65th American Society of Hematology (ASH) held from 9 to 12 December 2023, the Group presented the preliminary clinical safety and efficacy results of the phase I/II study of GB261 (CD20/CD3, BsAb) led by Beijing Cancer Hospital in the poster session.

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  • GB261, a CD20/CD3, BsAb that has Fc functions and affinity adjustment to CD3, demonstrated a highly advantageous safety/efficacy balance in the FIH study in patients with relapsed/refractory non-Hodgkin B-cell Lymphoma (Poster Number: 1719).

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  • As at 17 June 2023, 47 r/r B-NHL patients (DLBCL: 76.6%; FL: 23.4%) were enrolled at flat or step-up doses of GB261 (CD20/CD3, BsAb) ranging from 1mg to 300mg.

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  • In efficacy evaluable patients (n=22) from 3mg to 100mg, the overall response rate (ORR) was 73% (16/22), and complete response rate (CRR) was 45.5% (10/22).

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  • Preliminary clinical data showed favourable tolerability: In safety evaluable patients (n=47). Cytokine Release Syndrome (CRS) occurred in 12.8% (6/47) patients, was mild and transient. CRS in 100mg were 14.3% (2/14). All cases of CRS were grade 1 (8.5%, 4/47) or 2 (4.3%, 2/47), no grade 3 (Lee et al., ASTCT criteria), no interruptions of treatment, and no administration of Tocilizumab. The median duration of CRS was 7 hours. No Immune effector cell-associated neurotoxicity syndrome (ICANS) were reported.

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  • Pharmacokinetics (PK): long half-life, supports tri-weekly dosing. The PK profile of GB261 (CD20/CD3, BsAb) appeared to be linear across dose ranges tested (1mg-100mg). Effective half-life appeared to be 2-3 weeks which supports every 3-4 weeks dosing.

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  • The clinical trial concluded that in heavily pretreated B-NHL patients, GB261 (CD20/CD3, BsAb) showed a highly advantageous safety/efficacy balance. The safety profile is excellent especially for the CRS which is very mild, transient and less frequent compare with other CD20/CD3 bispecific antibodies. The response after GB261 (CD20/CD3, BsAb) treatment was early, deep and durable. Additionally, clinical benefit seen in other CD20/CD3 bispecific antibody failed patients provides clinical support to the unique and differentiated mechanism of action of GB261 (CD20/CD3, BsAb).

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Currently, the Company is actively pushing forward the negotiation with global clinical development/commercialisation partners in respect of GB261 (CD20/CD3, BsAb). It plans to enter into cooperation agreements in 2024.

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GB263T (EGFR/cMET/cMET, TsAb) – the dose-escalation of 1,680mg was completed in the phase I/II clinical trial and radiological responses were observed.

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GB263T (EGFR/cMET/cMET, TsAb) is the first tri-specific antibody of EGFR/cMET/cMET in the world, targeting EGFR and two different epitopes of cMET, therefore, to enhance its safety and efficacy. With highly differentiated design, GB263T (EGFR/cMET/cMET, TsAb) exhibits multiple mechanisms of action to inhibit primary and secondary EGFR mutations and cMET signaling pathway simultaneously.

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In pre-clinical studies, GB263T (EGFR/cMET/cMET, TsAb) effectively thwarted ligand-induced phosphorylation of EGFR and c-MET compared to its Amivantamab (JNJ-372) analogue, and demonstrated better dual inhibition of EGFR and cMET signaling pathways. Meanwhile, GB263T (EGFR/cMET/cMET, TsAb) effectively induced the endocytosis of EGFR and cMET, and significantly reduced the protein expression levels of EGFR and cMET. GB263T (EGFR/cMET/cMET, TsAb) played a significant dosage-dependent role in tumor suppression in several different tumor models including EGFR exon 20 insertions, EGFR exon 19 deletions, C797S mutations and various cMET expression abnormalities. In toxicology studies in cynomolgus monkeys, no significant toxic side effects were observed after 4 weeks of observation, even in the highly-dosed group.

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As of August 2023, the dose-escalation of 1,680mg was completed in the phase I/II clinical trial of GB263T (EGFR/cMET/cMET, TsAb). Radiological responses were observed in the 1,260mg and 1,680mg dose groups.

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On 1 December 2023, the Group published preliminary dose escalation results from a phase I/II study of GB263T, a novel EGFR/cMET/cMET TsAb, on Molecular Cancer Therapeutics of the AACR journal:

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  • Dose-escalation results from a FIH, phase I/II study of GB263T (EGFR/cMET/cMET, TsAb) in patients with advanced EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) (Abstract Number C114).

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  • Results to date demonstrate a good safety profile of GB263T (EGFR/cMET/cMET, TsAb) with promising efficacy at the therapeutic dose range (1,260-1,680 mg).

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  • Preliminary clinical data demonstrated good safety and tolerability, with an infusion reaction rate (IRR) of 35.7%, significantly lower than that of the compound in the same class (66%), and were mild with only graded 1/2. No MET target-related peripheral edema was reported.

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  • As of 5 July 2023, 13 patients were treated: 140 mg (n=1), 420 mg (n=1), 840 mg (n=3), 1,260 mg (n=3), 1,680 mg (n=5). The enrolment of the 1,680 mg cohort is ongoing. All patients had received previous third-generation EGFR-TKI and platinum-based chemotherapy. Median number of prior lines of systemic therapy was 3 (range 1-7). One patient at 1,680 mg of GB263T (EGFR/cMET/cMET, TsAb) experienced dose-limiting toxicity (DLT) (grade 3 oral mucositis, which has resolved after symptomatic treatment). The most common treatment-related adverse events (TRAEs) were rash (61.5%), infusion related reaction (38.5%), fatigue (30.8%) and myalgia (23.1%), and all are mild (grade 1/2). Only one patient developed ≥ grade 3 TRAE (grade 3 oral mucositis). There were no treatment-related discontinuations. Among 10 response-evaluable patients, two achieved partial response (PR) and four achieved stable disease (SD) with tumor shrinkage observed in 3/4 SD patients. The disease control rate (DCR) is 60%. The objective response rate (ORR) at the therapeutic dose range (1,260-1,680 mg) is 40% (2/5). 2 PR patients and 2 SD patients remained on treatment at data cutoff.

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Research and Development of the Global Innovative New Drugs - focused on developing targeted antibodies and projects with FIC potential

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From 1 to 5 November 2023, the Company participated in the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) in 2023, and shared research data of the following two innovative drug molecules in the poster discussion session:

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  • GBD201 (CCR8/CTLA-4, BsAb) (Abstract Number: 491):

GBD201 is a bispecific antibody targeting CCR8/CTLA-4 developed independently by the Company. This bispecific antibody is equipped with a unique molecular design and highly differentiate functions to maximally reduce the potential toxicity caused by CTLA4 inhibition (such as ipilimumab or tremelimumab).

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  • CCR8 is predominantly expressed on regulatory T cells (Tregs) in the tumor microenvironment. Leveraging on such characteristic of CCR8, GBD201 combined with CCR8 with high affinity, driving the BsAb to efficiently combine with Tregs in the tumor microenvironment. In contrast, a partial blocker was selected for the CTLA-4 arm, which only partially blocked the binding of CTLA-4 and CD80/CD86. Furthermore, GBD201 exhibited a combination dependent on the expression of CCR8 and blocked the interactions of CTLA-4, further reducing the peripheral toxicity of CTLA-4 inhibition.

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  • GBD201 is a tetravalent antibody composed of CCR8 monoclonal antibody and CTLA-4 VHH nanobody, with a symmetric structure. Its anti-tumor efficacy is mainly achieved through the following mechanisms: 1) GBD201 targeting CCR8+CTLA4-4+ double-positive cells and killing Tregs in the tumor microenvironment by enhancing ADCC function; 2) GBD201 blocking the interaction of CCR8 and CCL1 on Treg cells, thereby inhibiting Treg migration; 3) special epitope of CTLA4 in GBD201 that only partially blocking the interaction of CTLA-4 and its ligands CD80/86, which is highly dependent on the expression of CCR8 on the cell membrane, with very weak blocking activity on CTLA-4 single-positive cells, and intentionally designed to reduce the immune-related toxicity of CTLA-4 inhibition in the periphery.

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  • On hCCR8/hCTLA-4 double KI mice, GBD201 significantly inhibited tumor growth in the bladder cancer model MB49 and the colorectal cancer model MC38, demonstrating similar or slightly better tumor inhibition effect compared to Ipilimumab, with much better efficacy than that of anti-CCR8 monoclonal antibody. In Tumor Infiltrating Lymphocytes (TIL) analysis, it was found that GBD201 significantly reduced Treg while CD8+T cells significantly increased. The most important differentiation of GBD201 may lie in its significantly improved safety profile. In hCCR8/hCTLA-4 mice, the combination of Ipilimumab (20 mpk) and anti-mouse PD1 antibody could induce obvious joint inflammation, while GBD201 at the same molar dose (23.3 mpk) or five times higher molar dose (116.7 mpk) combined with anti-mouse PD1 antibody did not trigger any joint inflammation. Therefore, GBD201 exhibits excellent anti-tumor activity in preclinical mouse tumor models, and its safety profile is at least 5 times higher than that of Ipilimumab in toxicology model of mice. It has the potential to become a more effective and safe immune checkpoint inhibitor, and may achieve better efficacy and tolerance in clinical treatment in combination with other drugs.

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  • GBD209 (PD-1/CTLA-4/TIGIT, TsAb) (Abstract Number: 492):

GBD209 is the first tri-specific antibody independently developed by the Company targeting these three immune checkpoints. By simultaneously blocking the PD-1/CTLA-4/TIGIT inhibitory pathways on T cells, it better relieves immune suppression on T effector cells and produces better anti-tumor synergistic effects.

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  • GBD209 has a hexavalent symmetric structure composed of VHH nanobody. GBD209 achieves anti-tumor efficacy through the following mechanisms: 1) completely blocking both PD-1 and TIGIT signaling pathways, while partially blocking the CTLA- 4 mediated signaling pathway; 2) high affinity for binding PD-1 and TIGIT, but the interaction of CTLA-4 is highly dependent on the expression of PD-1 on the cell membrane; 3) inducing target endocytosis of PD-1, TIGIT, and CTLA-4; 4) nanobody with smaller molecular weights providing better tissue penetration.

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  • In the humanized mouse melanoma A375 model, GBD209 showed better anti-tumor activity compared to PD1/CTLA-4 bsAb as well as the combination therapy of antiPD-1, CTLA-4, and TIGIT antibodies. In the toxicology model of mice, the safe dose of GBD209 is at least 15 times higher than that of Ipilimumab. In the toxicological model of mouse arthritis, GBD209 demonstrated a favorable safety profile. In hPD-1/hCTLA-4/hTIGIT triple transgenic mice, the combination of Ipilimumab (15mpk) and nivolumab induced obvious joint inflammation and resulted in 60% of mouse deaths, while GBD209 only induced mild joint inflammation in a few animals at 5 times higher molar dose (62.5 mpk) or 15 times higher molar dose (187.5 mpk), with no mouse deaths. This result indicates that GBD209 has significantly improved safety profile compared to Ipilimumab, and has the potential to become a low toxicity and efficient next-generation immune checkpoint inhibitor. It can also be further combined with other therapies (such as ADC), which may significantly improve clinical efficacy.

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As of 31 December 2023, five Preclinical candidate compounds (PCC) molecules have been developed, all of which are the FIC/BIC bi-specific/multi-specific antibody projects. Abstracts of two of TsAb projects have been accepted for publication at the 2024 Annual Meeting of the American Association for Cancer Research (AACR). And GB268 (TsAb) has entered the IND enabling stage.

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Focus on resources, optimization promotion, Cooperative expansion

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With regards to concentration and optimization, the Company plans to achieve the approval of the NDA for GB491 (Lerociclib) in combination with Fluvestran as the treatment of HR+/HER2– locally advanced or metastatic breast cancer patients with disease progression following previous endocrine therapy. The Group will actively seek partners to introduce safe, effective and well tolerated novel therapies, in order to address the treatment needs of large number of patients with breast cancer in China and around the world.

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As for bi-specific and tri-specific antibody drug candidates, the Group will actively expand external partnership in its clinical programs on the basis of the clinical concept validation data for GB261 (CD20/CD3, BsAb) and GB263T (EGFR/cMET/cMET, TsAb).

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FINANCIAL HIGHLIGHTS

  • Total comprehensive loss was approximately RMB676.0?million for the Reporting Period, as compared with approximately RMB731.8 million for the year ended 31 December 2022. The decrease was primarily due to the decrease in expenses.
  • Research and development expenses were approximately RMB564.3 million for the Reporting Period, as compared with approximately RMB583.9 million for the year ended 31 December 2022. The decrease was mainly due to the decrease in employee benefits expenses.
  • As at the end of December 2023, the cash balance was RMB1,165 million.
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