Metastatic Gastroesophageal Junction Adenocarcinoma

BOSTON, Sept. 23, 2024 /PRNewswire/ -- Elevation Oncology, Inc. (Nasdaq: ELEV), an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy. "We are delighted to receive Fast Track designation for EO-3021, which marks an encouraging recognition of the unmet medical need in patients with Claudin 18.2-expressing tumors, as well as the potential for EO-3021 to deliver improved therapeutic outcomes," said Joseph Ferra, President and Chief Executive Officer of Elevation Oncology. "This designation is based on nonclinical and initial clinical data from our ongoing Phase 1 clinical trial. As we announced in August, early results showed a confirmed overall response rate of 42.8% in a Claudin 18.2-enriched subset of gastric and GEJ cancer. In addition, we observed differentiated tolerability, with minimal MMAE-associated toxicities, including no neutropenia or peripheral neuropathy/hypoesthesia. We are grateful for the opportunity to potentially expedite the delivery of EO-3021 and look forward to advancing through monotherapy dose expansion and reporting additional data from our ongoing trial in the first half of 2025, and to initiating the combination portion of our study later this year." Fast Track is a process designed by the FDA to facilitate the development and expedite the review of therapeutic candidates intended to treat serious or life-threatening conditions, for which nonclinical or clinical data demonstrate the potential to address unmet medical needs. Therapeutic candidates that receive FTD may be eligible for more frequent interactions with the FDA to discuss the candidate's development plan. Therapeutic candidates with Fast Track designation may also be eligible for priority review and accelerated approval if supported by clinical data. About EO-3021 EO-3021 is a differentiated, clinical-stage antibody drug conjugate (ADC) with best-in-class potential comprised of an immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets Claudin 18.2 and a monomethyl auristatin E (MMAE) payload with a cleavable linker that is site-specifically conjugated to Glutamine 295 providing a drug-to-antibody ratio (DAR) of 2. Claudin 18.2 is a specific isoform of Claudin 18 that is normally expressed in gastric epithelial cells. During malignant transformation, the tight junctions may become disrupted, exposing Claudin 18.2 and allowing them to be accessible by Claudin 18.2 targeting agents. Elevation Oncology is evaluating EO-3021 in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Elevation Oncology has the exclusive rights to develop and commercialize EO-3021 in all global territories outside Greater China. About Elevation Oncology, Inc. Elevation Oncology is an innovative oncology company focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are leveraging our antibody-drug conjugate (ADC) expertise to advance a novel pipeline, initially targeting two clinically validated targets in oncology, Claudin 18.2 and HER3. Our lead candidate, EO-3021, is a potential best-in-class ADC designed to target Claudin 18.2 and is currently being evaluated in a Phase 1 trial (NCT05980416) in patients with advanced, unresectable or metastatic solid tumors likely to express Claudin 18.2 including gastric, gastroesophageal junction, pancreatic or esophageal cancers. Additionally, we expect to nominate a development candidate for our second program, a HER3-targeting ADC for the treatment of patients with solid tumors that overexpress HER3, in 2024. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated clinical and preclinical development activities, expected timing of announcements of clinical results, potential benefits of Elevation Oncology's product candidates, potential market opportunities for Elevation Oncology's product candidates and the ability of Elevation Oncology's product candidates to treat their targeted indications. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "might," "plan," "possible," "potential," "will," "would," and other words and terms of similar meaning. Although Elevation Oncology believes that the expectations reflected in such forward-looking statements are reasonable, Elevation Oncology cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval are inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause Elevation Oncology's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to Elevation Oncology's ability to advance its product candidates, the timing and results of preclinical studies and clinical trials, approvals and commercialization of product candidates, the receipt and timing of potential regulatory designations, Elevation Oncology's ability to fund development activities and achieve development goals, Elevation Oncology's ability to protect intellectual property, Elevation Oncology's ability to establish and maintain collaborations with third parties, and other risks and uncertainties described under the heading "Risk Factors" in documents Elevation Oncology files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Elevation Oncology undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Elevation Oncology Investor and Media Contact Hannah Deresiewicz, 212-362-1200 EVP, Managing Director, Precision AQ [email protected] SOURCE Elevation Oncology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China , Aug. 27, 2024 /PRNewswire/ -- Keymed Biosciences Inc. (HKEX: 02162) today announced its interim results for the first half of 2024, along with a corporate update. Rapid development of our pipeline products Stapokibart (CM310) (IL-4Rα antibody) In June 2024, the long-term efficacy and safety data from the Phase III clinical trial of Stapokibart injection for the treatment of moderate-to-severe AD were presented by way of oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. The study showed that at week 52, the rates of achieving EASI-75 and EASI-90 for the Stapokibart group was 92.5% and 77.1%, respectively. The rates of achieving an IGA score of 0 or 1 point with a reduction of ≥ 2 points from baseline was 67.3%. Long-term treatment with Stapokibart can consistently improve dermatitis symptoms and quality of life in subjects with moderate-to-severe AD. In terms of safety, Stapokibart was safe and well-tolerated after 52 weeks of administration, with safety profiles consistent with those observed at week 16 and no new safety signals identified. Advanced and completed the 52-week treatment and safety follow-up of the Phase III clinical study of Stapokibart injection for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in the first half of 2024. In June 2024, the new drug application of Stapokibart injection for the treatment of CRSwNP was accepted by the NMPA and granted priority review. Advanced and completed the unblinding of data and the statistical analysis of the Phase III clinical study of Stapokibart injection for the treatment of seasonal allergic rhinitis (SAR) in the first half of 2024, with the clinical data meeting the primary endpoints. In April 2024, the new drug application of Stapokibart injection for the treatment of SAR was accepted by the NMPA. Launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in adolescent subjects with moderate-to-severe AD in February 2024. Launched a randomized, double-blinded, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of Stapokibart injection in prurigo nodularis subjects in May 2024. Our partner CSPC initiated the critical Phase II/III clinical study for the treatment of moderate-to-severe asthma and moderate-to-severe COPD. CMG901/AZD0901 (Claudin 18.2 ADC) As of the date of this announcement, AstraZeneca has conducted multiple clinical studies regarding CMG901 (AZD0901) for the treatment of advanced solid tumors. Among these, an international multi-center Phase III study comparing CMG901 (AZD0901) monotherapy versus investigator's choice as second-line or later-line treatment in patients with advanced or metastatic gastric and gastroesophageal junction (G/GEJ) cancer expressing Claudin 18.2 was publicly announced on the drug clinical trial registration and information publicity platform in March 2024. The first patient has received the initial dose in April 2024. In June 2024, the latest data from a Phase I clinical study of CMG901 (AZD0901) in the treatment of advanced G/GEJ cancer were presented by way of oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting 2024. The study results indicated that as of February 2024, among 89 evaluable patients with Claudin 18.2-high expressing (defined as Claudin 18.2 membrane intensity ≥2+ in ≥20% of tumor cells) G/GEJ cancer in three cohorts, confirmed objective response rate (ORR) and confirmed disease control rate (DCR) were 35% and 70%, respectively. In the 2.2 mg/kg dose group, the confirmed ORR was 48%. The median progression free survival (mPFS) for all 93 patients with Claudin 18.2-high expressing G/GEJ cancer was 4.8 months, and the median overall survival (mOS) was 11.8 months. CM313 (CD38 antibody) Continued to advance a multi-center, open-label, dose-escalation and dose-expansion Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM313 injection in patients with RRMM, lymphoma, and other hematological malignancies. Continuously proceeded with a randomized, double-blinded, placebo-controlled, dose-escalation, multiple-dose Phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary efficacy of CM313 injection in subjects with SLE. In June 2024, a research paper titled "A Novel Anti-CD38 Monoclonal Antibody for Treating Immune Thrombocytopenia" was published in The New England Journal of Medicine. This is an investigator-initiated, single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of CM313 in adult patients with primary immune thrombocytopenia. The results showed that 95.5% of patients (21/22) achieved a platelet count of ≥50 × 109/L within 8 weeks upon the first acceptance of CM313 infusion, with a median cumulative duration for a platelet count of ≥50 × 109/L of 23 weeks (interquartile range: 17-24). Additionally, the durable platelet count response rate (defined as a platelet count of ≥50 × 109/L observed six or more times among the final eight platelet counts) was 63.6% (14/22). In June 2024, we have submitted an IND application to further assess the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of CM313 in patients with primary immune thrombocytopenia. CM326 (TSLP antibody) In May 2024, we initiated a randomized, double-blinded, placebo-parallel Phase II clinical study to evaluate the efficacy and safety of CM326 in patients with CRSwNP, further exploring the optimal dosage. Our partner CSPC initiated the Phase II clinical study for the treatment of moderate-to-severe asthma. CM355/ICP-B02 (CD20xCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical trial in the first half of 2024 to assess the safety, tolerability, pharmacokinetics, and the preliminary anti-tumor activity of CM355 in relapsed or refractory non-Hodgkin's lymphoma (NHL). As of the date of this announcement, dose escalation of the intravenous infusion formulation (IV) was completed and the subcutaneous formulation (SC) is in the process of patient evaluation. CM336 (BCMAxCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study to assess the safety, tolerability, pharmacokinetics, and the anti-tumor activity of CM336 in RRMM. CM350 (GPC3xCD3 bispecific antibody) Continuously proceeded with a Phase I/II clinical study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of CM350 in patients with advanced solid tumors. CM369/ICP-B05 (CCR8 antibody) Continuously proceeded with a Phase I clinical study in the first half of 2024 to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of CM369 in subjects with advanced solid tumors and relapsed or refractory NHL. CM383 (Aβ protofibrils antibody) Initiated a Phase I clinical study of the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single dose-escalation administration of CM383 in healthy subjects. The enrollment of the first subject was completed in June 2024. CM380 (GPRC5DxCD3 bispecific antibody) Submitted IND application, and planned to conduct a multi-center, open-label Phase I/II clinical study for evaluation of CM380 in treatment of patients with relapsed or refractory multiple myeloma. Financial and Business Highlights Actively carry out the out-licensing collaboration In July 2024, Chengdu Keymed and Belenos entered into an out-license agreement, which grants Belenos an exclusive right to develop, manufacture and commercialize the Group's drug candidates, CM512 and CM536, globally excluding the Greater China region. In return, Chengdu Keymed shall receive an upfront and nearterm payment of US$15 million, and iBridge HK Holdings Limited, a wholly-owned subsidiary of the Group, shall receive approximately 30.01% of the equity interest in Belenos as consideration. Subject to achievement of certain development, regulatory and commercial milestones, Chengdu Keymed may also receive additional payments of up to US$170 million. Chengdu Keymed is also entitled to receive tiered royalties from Belenos on net sales for a specified period of time commencing after the first commercial sale of CM512 and CM536. Expand manufacturing capacity and efficiently prepare for commercialization We continue to recruit talents to meet the growing needs of commercialization, research and development, clinical, production and operation of the Company. We further expanded our cGMP-compliant manufacturing capacity, efficiently prepared for the company to become a commercial organization. As of the date of this announcement, the production capacity of our production base has reached 18,600 litres in total, and all the designs thereof are in compliance with the requirements of cGMP of the NMPA and FDA. Financial highlights As of June 30, 2024, the Company held cash (including bank wealth management products) of RMB 2.58 billion. R&D expenses of the Group increased by RMB 81 million to RMB 331 million, from RMB 250 million for the six months ended June 30, 2023. During the Reporting Period, the Group's revenue amounted to RMB 54.6 million, mainly consisted of the 1st milestone revenue from AZ on the CMG901 license transaction. SOURCE Keymed

Total revenue of RMB 254.2 million for 2024 H1; achieving first-time profitability with cash reserve at RMB 814 million as of June 30, 2024. NDA approval of sugemalimab (PD-L1) for Stage IV NSCLC in EU, marking the first successful international approval of a China domestic anti-PD-L1 mAb. Partnered with Ewopharma for sugemalimab commercialization in Central and Eastern Europe, expecting more global partnerships for sugemalimab in the rest of 2024. To launch sugemalimab in Europe and other ex-China markets in early 2025 and to support the company to achieve sustained profitability. Key Pipeline 2.0 asset – CS5001, the first ROR1 ADC with clinical anti-tumor activity in both solid tumors and lymphomas; initiation of a phase 1b study in lymphomas with registrational potential expected in 2024. Key Pipeline 2.0 asset – CS2009, a trispecific antibody targeting PD-1, CTLA4, and VEGFa; aiming for IND submissions in 2024 / 2025. Partnered with Hengrui Pharmaceuticals to commercialize AYVAKIT® (avapritinib) in mainland China. AYVAKIT®'s manufacturing localization application approved by China NMPA; GAVRETO®'s (pralsetinib) application under review. Domestic manufacturing of both precision medicines will significantly reduce costs and improve long-term profitability. New NDA approval of sugemalimab (PD-L1) for first-line gastric cancer in China; NDA for Stage IV NSCLC currently under review by UK MHRA. The Company to host an interim results investor conference call in Chinese on August 26th at 10:00-11:00 am HKT. SUZHOU, China, Aug. 23, 2024 /PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today reported interim financial results for 2024 and recent business highlights. Dr. Jason Yang, CEO, President of R&D, and Executive Director of Board at CStone, said, "The first half of 2024 marks an important turning point for CStone's growth, achieving several critical milestones and outstanding financial performance. With diversified revenue streams and ongoing cost control, we achieved profitability for the first time and laid a solid foundation for company's future growth. The EU approval of sugemalimab for first-line Stage IV NSCLC represents a significant breakthrough in our global strategy. In addition to the commercial agreement reached this year with Ewopharma for Central and Eastern Europe, we anticipate expanding sugemalimab partnerships across Western Europe and other regions in the rest of 2024, with global sales to commence from early 2025. We are confident that sugemalimab – a potential best-in-class anti-PD-L1 antibody – will deliver significant revenue to support the company to achieve sustained profitability. Pipeline 2.0 is the "new growth engine" for CStone. We will initiate a phase 1b study of CS5001 (ROR1 ADC) with registrational potential for lymphoma in 2024, and plan to present updated clinical data at the American Society of Hematology (ASH) annual meeting later this year. CS2009 (a trispecific antibody targeting PD-1, CTLA4, and VEGFa) is expected to enter an FIH clinical trial in 2024/2025. Meanwhile, we are advancing more innovative assets for oncology and autoimmune diseases with global rights towards clinical stage. Following the commercialization agreement with and successful transition to Allist to commercialize GAVRETO® (pralsetinib) in China last year, we entered a partnership with Hengrui Pharmaceuticals to commercialize AYVAKIT® (avapritinib) in China to leverage its large and strong sale force. Earlier this year, we received the approval for AYVAKIT®'s manufacturing localization application and filed an application for GAVRETO®. With reduced costs of goods from local supply and the strong commercial capability from our partners, we expect rapid sales growth for these two precision medicines to contribute sustainable profit to the Company in coming years. In terms of regulatory progress, sugemalimab received approval in mainland China for first-line gastric cancer, further broadening its coverage in the domestic market. In ex-China market, the UK Medicines and Healthcare products Regulatory Agency (MHRA) is currently reviewing sugemalimab marketing authorization application (MAA) for first-line Stage IV NSCLC that has recently been approved by the European Commission (EC). We plan to submit additional MAAs to the European Medicines Agency (EMA) for other indications of sugemalimab, including Stage III NSCLC, first-line gastric cancer, first-line esophageal squamous cell carcinoma (ESCC), and relapsed/refractory extranodal NK/T-cell lymphoma. Looking ahead, CStone will work closely with our commercial partners to drive the commercial performance of AYVAKIT® and GAVRETO® in China and sugemalimab globally, continue to advance the innovative assets in Pipeline 2.0 to the clinic, and expand our global business to achieve sustained profitability." Financial Highlights International Financial Reporting Standards (IFRS) Measures: Revenue was RMB254.2 million for the six months ended June 30, 2024, composed of RMB118.3 million in sales of pharmaceutical products (avapritinib and pralsetinib), RMB122.6 million in license fee income and RMB13.3 million in royalty income of sugemalimab, representing an increase of RMB122.6 million in license fee income which largely offset a decrease of RMB128.6 million in revenue from sales of pharmaceutical products, such that total revenue decreased by RMB7.3 million, or 2.8%, period-on-period. Research and development expenses were RMB66.2 million for the six months ended June 30, 2024, representing a decrease of RMB120.6 million from RMB186.8 million for the six months ended June 30, 2023, primarily due to a decrease in milestone fee and third party contracting costs and a decrease in employee costs. Administrative expenses were RMB46.7 million for the six months ended June 30, 2024, representing a decrease of RMB42.5 million from RMB89.2 million for the six months ended June 30, 2023, primarily due to a decrease in employee costs. Selling and marketing expenses were RMB62.8 million for the six months ended June 30, 2024, representing a decrease of RMB68.6 million from RMB131.4 million for the six months ended June 30, 2023, primarily attributable to a decrease in employee costs. Profit for the period was RMB15.7 million for the six months ended June 30, 2024, representing a turnaround from a loss of RMB209.2 million for the six months ended June 30, 2023, primarily attributable to a substantial decrease in operating expenses and an increase in gross profit. Non-International Financial Reporting Standards (Non-IFRS) Measures: Research and development expenses excluding the share-based payment expenses were RMB71.0 million for the six months ended June 30, 2024, representing a decrease of RMB127.1 million from RMB198.1 million for the six months ended June 30, 2023, primarily due to a decrease in milestone fee and third party contracting costs and a decrease in employee costs. Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB109.6 million for the six months ended June 30, 2024, representing a decrease of RMB73.5 million from RMB183.1 million for the six months ended June 30, 2023, primarily attributable to a decrease in employee costs. Profit for the period excluding the share-based payment expenses was RMB10.8 million for the six months ended June 30, 2024, representing a turnaround from the loss of RMB183.0 million for the six months ended June 30, 2023, primarily attributable to a substantial decrease in operating expenses and an increase in gross profit. Business Highlights For the six months ended June 30, 2024 and as of the date of this announcement, tremendous progress has been made with respect to our product pipeline and business operations. Key achievements over this period include: Key Pipeline Highlights: Immunotherapy Sugemalimab (anti-PD-L1 antibody) EU Approval: In July 2024, the European Commission (EC) approved sugemalimab (Brand name: Cejemly®) in combination with platinum-based chemotherapy for the first-line treatment of adults with metastatic NSCLC with no sensitizing EGFR mutations, or ALK, ROS1 or RET genomic tumor aberrations. This marks the first successful international approval of a China domestic anti-PD-L1 monoclonal antibody. Sugemalimab's MAA for first-line Stage IV NSCLC is currently under review by the UK MHRA. Strategic Partnership: In May 2024, we entered a strategic collaboration with Ewopharma to commercialize sugemalimab in Switzerland and 18 CEE countries. CStone will receive up to $51.3 million consisting of an upfront payment and additional payables upon regulatory and sales milestones. Fifth Indication Approved in China: In March 2024, sugemalimab was approved in China for its fifth indication – sugemalimab in combination with fluoropyrimidine- and platinum-containing chemotherapy as a first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma with a PD-L1 expression (Combined Positive Score [CPS] ≥5). Publication in Nature Medicine: In February 2024, the progression-free survival (PFS) final analysis and overall survival (OS) interim analysis of the GEMSTONE-304 study (first-line ESCC) were published in a top-tier medical journal – Nature Medicine. Long-Term OS Data at ESMO: In July 2024, the long-term OS analysis of the GEMSTONE-302 study (first-line Stage IV NSCLC) was accepted for poster presentation at the 2024 Congress of European Society for Medical Oncology (ESMO). Guideline Inclusion: In 2024, Cejemly® (sugemalimab) is recommended as a Tier-1 treatment based on Class-1A evidence in multiple Chinese clinical guidelines, including the CSCO guidelines for gastric cancer, esophageal cancer, and immune checkpoint inhibitors, and included in the Chinese Expert Consensus on Immunotherapy for Lymphoma. Nofazinlimab (PD-1) Global Phase III Study: In March 2024, we completed a prespecified interim analysis for the global phase III trial of nofazinlimab in combination with LENVIMA® (lenvatinib) for the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC). No new or unexpected safety signals were observed, and the independent Data Monitoring Committee (iDMC) recommended continuing the trial without protocol modifications until the final OS analysis. Pipeline 2.0 CS5001, a receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC) First-in-Human Study: The global first-in-human (FIH) is ongoing in the US, Australia and China. As of the date of this announcement, the dose has been escalated to the 10th level without observing any dose-limiting toxicities (DLTs) or reaching the maximum tolerated dose (MTD). Promising Antitumor Activity: CS5001 has been well tolerated and safe and has exhibited encouraging anti-tumor activities in various solid tumors and hematologic malignancies. CS5001 is so far the first ROR1 ADC known to demonstrate clinical anti-tumor activity in both solid tumors and lymphomas. ASCO 2024 Presentation: On June 1, 2024, we presented the latest FIH data at the 2024 ASCO annual meeting in a poster session. We also plan to disclose more lymphoma data at the 2024 ASH annual meeting. Phase 1b with Registrational Potential: We plan to initiate phase Ib dose-expansion studies with registrational potential in multiple indications for dose optimization by the end of 2024. ROR1 Antibody Development: We have identified a promising candidate ROR1 antibody clone for immunohistochemistry (IHC) and plan to evaluate the relationship between ROR1 expression and efficacy in phase 1b. CS2009 (PD-1, CTLA4 and VEGFa Trispecific Antibody) Potential FIC/BIC: CS2009 is potentially FIC/BIC next-generation I/O backbone that targets three critical immune suppressive pathways in tumor microenvironment and has the potential to enhance the efficacy of PD-(L)1 therapies in high-prevalence cancers, including NSCLC and HCC. IND Submission: Currently under IND-enabling process; IND submissions expected in 2024/2025. FIC/BIC ADCs CS5006 (Novel Target) & CS5005 (SSTR2): Two FIC ADC programs are advancing toward PCC nomination. CS5006, targeting high-prevalence tumors with a novel tumor-associated antigen identified using in-house machine-learning bioinformatic algorithm, is expected to submit IND in 2025. CS5005 (SSTR2 ADC) has demonstrated encouraging in vitro and in vivo efficacy with its conjugated lead molecules; IND submission expected in 2025. CS5007 (EGFRxHER3 Bispecific ADC) & CS2011 (EGFRxHER3 Bispecific Antibody) are progressing towards PCC nomination. CS5007 (CS2011) targets EGFR and HER3, and both are well-validated targets with proven syngeneic antitumor activity. IND submissions are expected in 2025. Autoimmune Multispecific Antibody CS2013, which is a bispecific molecule targeting two key pathways critical for B-cell development, is in discovery stage, with selection of lead molecule expected by the end of 2024. CS2013 is designed to address unmet needs in treating systemic lupus erythematosus (SLE), IgA nephropathy (IgAN), and other B-cell mediated autoimmune diseases. Precision Medicine GAVRETO® (pralsetinib) Manufacturing Localization in Process: In April 2024, the application of manufacturing localization for GAVRETO® has been accepted by CDE of China NMPA and is currently under review. Commercial Transition: Following the exclusive commercialization agreement for GAVRETO® in November 2023, we transitioned commercial activities to Allist in 2024 H1 and are in close collaboration. AYVAKIT® (avapritinib) Manufacturing Localization Approved: The manufacturing localization applications of AYVAKIT® (300mg and 100mg) were approved by China NMPA in June and August 2024. Partnership with Hengrui Medicine: In July 2024, we entered an exclusive partnership with Hengrui to commercialize AYVAKIT® in mainland China. CStone received an upfront payment of RMB 35 million and will continue to book sales revenue from AYVAKIT® in mainland China in our financial reports, with service fees payable to Hengrui. Inclusion in National Reimbursement Drug List (NRDL): AYVAKIT® was included to the 2023 NRDL in China for the treatment of adults with unresectable or metastatic GIST harboring the PDGFRA exon 18 mutation, including PDGFRA D842V mutations. The updated NRDL has been implemented since January 1, 2024. Guideline Inclusions: GAVRETO® and AYVAKIT® were included in 15 national guidelines in China, covering multiple therapeutic areas such as NSCLC, thyroid cancer (TC), GIST, systemic mastocytosis (SM), etc. Future and Outlook Looking forward, we remain committed to advancing our innovative pipeline and maximizing commercial value of our marketed products. Anticipated near-term catalysts include Sugemalimab: MAA approval for the first-line treatment of Stage IV NSCLC in the U.K. expected in 2024 H2, and more global partnerships expected in 2024. CS5001: Presentation of the latest clinical safety and efficacy data at international academic conferences (e.g. ASH in 2024 H2), initiation of phase 1b trial with registrational potential in 2024, and global business development (BD) partnerships expected in 2024 or 2025. CS2009: IND submissions expected in 2024/2025. CS5006: IND submission expected in 2025. CS5005: IND submission expected in 2025. CS2011/CS5007: IND submission expected in 2025. GAVRETO® (pralsetinib): Approval for manufacturing localization expected in 2025 H1. Nofazinlimab: Final OS analysis expected in 2025 H1; seeking ex-China partnership opportunities. Interim Results Investor Call The Company will host a 2024 interim results conference call at 10:00 a.m. to 11:00 a.m. (Hong Kong time) on Monday, August 26, 2024. Please attend the conference call through the link: (Password:564723). About CStone CStone (HKEX: 2616), established in late 2015, is an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies. Dedicated to addressing patients' unmet medical needs in China and globally, the Company has made significant strides since its inception. To date, the Company has successfully launched 4 innovative drugs and secured approvals for 14 new drug applications (NDAs) covering 9 indications. The company's pipeline is balanced by 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies and precision medicines. CStone also prides itself on a management team with comprehensive experiences and capabilities that span the entire drug development spectrum, from preclinical and translational research to clinical development, drug manufacturing, business development, and commercialization. For more information about CStone, please visit . IR contact: [email protected] PR contact: [email protected] Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. SOURCE CStone