{"id":21196,"date":"2023-08-15T14:33:00","date_gmt":"2023-08-15T14:33:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4184622_AE84622_0"},"modified":"2023-08-15T14:33:00","modified_gmt":"2023-08-15T14:33:00","slug":"cstone-pharmaceuticals-reports-2023-interim-results-and-updates","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=21196","title":{"rendered":"CStone Pharmaceuticals Reports 2023 Interim Results and Updates"},"content":{"rendered":"<ul type=\"disc\">\n<li>The total revenue was <span class=\"xn-money\">RMB 261.5 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>. The sales of pharmaceutical products revenue was <span class=\"xn-money\">RMB 246.9 million<\/span>, representing a growth rate of 53% compared to the same period last year. Commercial gross profit margin improved from 47% to 59%.<\/li>\n<li>Healthy financial position with cash reserves of <span class=\"xn-money\">RMB 1,005.4 million<\/span> as of <span class=\"xn-chron\">June 30, 2023<\/span>. The net loss amounted to <span class=\"xn-money\">RMB 183 million<\/span>, representing a decrease rate of 29% compared to the same period last year.<\/li>\n<li>Global multi-regional clinical trial of CS5001(ROR1 ADC), a potential blockbuster product of CStone Pipeline 2.0, has been expanded from <span class=\"xn-location\">the United States<\/span> and <span class=\"xn-location\">Australia<\/span> to <span class=\"xn-location\">China<\/span>, further accelerating its development; dose-finding phase I trial is ongoing, with results indicating good ADC stability, safety, tolerability, and preliminary anti-tumor activity.<\/li>\n<li>Five NDAs for sugemalimab (PD-L1) are currently under review and proceeding smoothly. Two were accepted in the UK and EU for first-line stage IV non-small cell lung cancer (NSCLC), and the Good Clinical Practice (GCP) inspection notification has recently been received from the European Medicines Agency (EMA). The other three were accepted in mainland <span class=\"xn-location\">China<\/span> for first-line gastric cancer, first-line esophageal cancer, and lymphoma. Approvals of the five applications are anticipated from the second half of 2023 to the first half of 2024.<\/li>\n<li>Two NDA approvals were obtained for pralsetinib, including the indication of first-line NSCLC in mainland <span class=\"xn-location\">China<\/span>.<\/li>\n<li>Company will host interim results conference calls in English and Chinese on <span class=\"xn-chron\">August 16th<\/span> at <span class=\"xn-chron\">9:30-10:30 am<\/span> HKT and <span class=\"xn-chron\">11:00-12:00 pm<\/span> HKT, respectively.<\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\">SUZHOU, <span class=\"xn-location\">China<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">Aug. 15, 2023<\/span><\/span> \/PRNewswire\/ &#8212; CStone Pharmaceuticals (&#8220;CStone&#8221;, HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today reported 2023 interim results and recent business updates.<\/p>\n<p>&#8220;In the first half of 2023, CStone delivered robust growth and positive results. Our three precision medicines achieved a 53% year-on-year increase in sales revenue with significant improvement of gross profit margin. Our cash reserves amount to <span class=\"xn-money\">RMB 1,005.4 million<\/span>, and we significantly reduced our net losses.&#8221; said Dr. <span class=\"xn-person\">Jason Yang<\/span>, CEO of CStone.<\/p>\n<p>&#8220;We made remarkable progress in our global product pipeline. We expanded the First-in-Human (FIH) global study of CS5001, a key product of our CStone Pipeline 2.0 Strategy, to <span class=\"xn-location\">China<\/span> from <span class=\"xn-location\">the United States<\/span> and <span class=\"xn-location\">Australia<\/span>, accelerating its development. The phase I clinical trial completed safety evaluation of several dose levels. CS5001, one of the most advanced ROR1 ADCs in global clinical development, showed promising safety, stability, and preliminary anti-tumor activity in hematological and solid malignancies.<\/p>\n<p>We are awaiting the approval of sugemalimab (PD-L1) as first-line treatment of Stage IV NSCLC in the UK and the EU, with the GCP inspection notification from the EMA received recently. We expect the approval in the first half of 2024. We are also actively looking for partners to develop and commercialize sugemalimab and nofazinlimab (PD-1) outside of the <span class=\"xn-location\">Greater China<\/span>, to advance the global commercialization of these assets.<\/p>\n<p>Going forward, we will continue to strengthen our research and development capabilities for innovative products, optimize the commercial potential of existing products, and improve our global strategic positioning, to create more growth opportunities for the company and more value for investors, partners, and stakeholders.&#8221;<\/p>\n<p><b>Business highlights<\/b><\/p>\n<p>The first half of 2023 has been a fruitful period for CStone with milestones across our evolving pipeline and business. We have four products in market which generate recurring revenue to provide financial strength and fund further growth initiatives. For the six months ended <span class=\"xn-chron\">June 30, 2023<\/span> and as of the date of this announcement, significant progress has been made with respect to our product pipeline and business operations. A shortlist of our achievements over this period includes:<\/p>\n<p>\u2013 <span class=\"xn-money\">RMB261.5 million<\/span> in total revenue which is composed of <span class=\"xn-money\">RMB246.9 million<\/span> in sales of our precision medicines and <span class=\"xn-money\">RMB14.6 million<\/span> in royalty income of sugemalimab<\/p>\n<p>\u2013 Two NDA approvals obtained for pralsetinib: first-line treatment of rearranged during transfection (&#8220;<b>RET<\/b>&#8220;) fusion-positive non-small cell lung cancer (&#8220;<b>NSCLC<\/b>&#8220;) in mainland <span class=\"xn-location\">China<\/span> which leads to a broader coverage of pralsetinib in both first-line and second-line NSCLC; and RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (&#8220;<b>MTC<\/b>&#8220;) &amp; RET fusion-positive thyroid cancer (&#8220;<b>TC<\/b>&#8220;) in <span class=\"xn-location\">Taiwan<\/span>, <span class=\"xn-location\">China<\/span><\/p>\n<p>\u2013 Five NDAs currently under review: sugemalimab for relapsed or refractory (<b>&#8220;R\/R<\/b>&#8220;) extranodal natural killer\/T-cell lymphoma (&#8220;<b>ENKTL<\/b>&#8220;) in mainland <span class=\"xn-location\">China<\/span>, sugemalimab for first-line stage IV NSCLC in the <span class=\"xn-location\">United Kingdom<\/span> (&#8220;<b>U.K.<\/b>&#8220;), sugemalimab for first- line stage IV NSCLC in the European Union (&#8220;<b>E.U.<\/b>&#8220;), sugemalimab for first-line gastric adenocarcinoma\/gastroesophageal junction adenocarcinoma (&#8220;<b>GC\/GEJ<\/b>&#8220;) in mainland <span class=\"xn-location\">China<\/span>, sugemalimab for first-line esophageal squamous cell carcinoma (&#8220;<b>ESCC<\/b>&#8220;) in mainland <span class=\"xn-location\">China<\/span>. The Good Clinical Practice (&#8220;<b>GCP<\/b>&#8220;) inspection notification from the European Medicines Agency (the &#8220;<b>EMA<\/b>&#8220;) for first-line stage IV NSCLC has been received<\/p>\n<p>\u2013 Global multi-regional clinical trial of CS5001 making rapid progress: the first-in-human (&#8220;<b>FIH<\/b>&#8220;) global study of CS5001, a receptor tyrosine kinase-like orphan receptor 1 (&#8220;<b>ROR1<\/b>&#8220;) antibody-drug conjugate (&#8220;<b>ADC<\/b>&#8220;), being conducted in <span class=\"xn-location\">the United States of America<\/span> (&#8220;<b>U.S.<\/b>&#8220;) and <span class=\"xn-location\">Australia<\/span>, and has now expanded to include <span class=\"xn-location\">China<\/span>, further accelerating the development of this product; dose finding phase I clinical trial has completed safety evaluation of several dose levels, with results indicating good safety and tolerability<\/p>\n<p>\u2013 Other key clinical programs proceeding smoothly: patient recruitment completed in the pivotal study of lorlatinib for c-ros oncogene 1 (&#8220;<b>ROS1<\/b>&#8220;)-positive advanced NSCLC in mainland <span class=\"xn-location\">China<\/span> and clinical trial progressing steadily for global phase III trial of nofazinlimab in combination with LENVIMA\u00ae (lenvatinib) in first-line advanced hepatocellular carcinoma (&#8220;<b>HCC<\/b>&#8220;)<\/p>\n<p>\u2013 Six data presentations\/publications at\/on global academic conferences\/top-tier medical journals, such as the ESMO World Congress on Gastrointestinal Cancer (&#8220;<b>ESMO GI Congress<\/b>&#8220;), Journal of Clinical Oncology, Nature Cancer, etc.<\/p>\n<p>\u2013 Over ten discovery projects in progress, including multi-specifics, antibody drug conjugates, and a proprietary cell penetrating therapeutic (&#8220;<b>CPT<\/b>&#8220;) platform for drugging intractable intracellular targets; in vitro proof-of-concept (&#8220;<b>PoC<\/b>&#8220;) for CPT with three therapeutic modalities has been achieved<\/p>\n<p>\u2013 The application of technology transfer for avapritinib is under review by the Center for Drug Evaluation (&#8220;<b>CDE<\/b>&#8220;) of the National Medical Products Administration (&#8220;<b>NMPA<\/b>&#8220;). The technology transfer for pralsetinib is proceeding smoothly, and a bio-equivalence (&#8220;<b>BE<\/b>&#8220;) study has been initiated<\/p>\n<p><b>I. New Indication Launches and Continued Robust Commercial Efforts<\/b><\/p>\n<p>Highlights and details on our commercial activities as of the date of this announcement are as follows:<\/p>\n<ul type=\"disc\">\n<li><b> Steady and Continued Ramp Up in Product Sales<\/b><\/li>\n<\/ul>\n<p>We generated overall net sales of <span class=\"xn-money\">RMB246.9 million<\/span> in the first half of 2023 on the basis of steady growth in the total product sales of GAVRETO\u00ae (pralsetinib), AYVAKIT\u00ae (avapritinib) and TIBSOVO\u00ae (ivosidenib).<\/p>\n<ul type=\"disc\">\n<li><b> Achieved successful launches of new indications<\/b><\/li>\n<\/ul>\n<p>We expanded the indications for our in-market products and positioned them to become meaningful future contributors to our revenue.<\/p>\n<p>\u2013 GAVRETO\u00ae (pralsetinib): The indication for the first-line treatment of patients with locally advanced or metastatic RET fusion-positive NSCLC was launched in mainland <span class=\"xn-location\">China<\/span>.<\/p>\n<p>\u2013 GAVRETO\u00ae (pralsetinib): The indications for the treatment of patients with RET fusion-positive locally advanced or metastatic NSCLC, and advanced or metastatic RET-mutant MTC and RET fusion-positive TC were launched in <span class=\"xn-location\">Taiwan<\/span>, <span class=\"xn-location\">China<\/span>.<\/p>\n<ul type=\"disc\">\n<li><b> Expansion of sales force coverage in key markets for prescriptions of precision drugs<\/b><\/li>\n<\/ul>\n<p>We have specifically focused our efforts on ensuring dedicated sales force coverage and successfully expanded our coverage to approximately 800 hospitals in over 180 cities as of the date of this announcement, up from 600 in 2021, accounting for approximately 75-80% of the relevant market for precision medicines where we believe we can maximize the return on our sales efforts.<\/p>\n<ul type=\"disc\">\n<li><b> Formed a precision diagnostics ecosystem with key stakeholders to facilitate patient identification<\/b><\/li>\n<\/ul>\n<p>\u2013 We have signed collaboration agreements with top gene sequencing companies to further improve the testing rate for RET mutation in NSCLC\/TC, platelet-derived growth factor receptor alpha (&#8220;<b>PDGFRA<\/b>&#8220;) exon 18 mutation in gastrointestinal stromal tumor (&#8220;<b>GIST<\/b>&#8220;) and isocitrate dehydrogenase 1 (&#8220;<b>IDH1<\/b>&#8220;) mutation in acute myeloid leukemia (&#8220;<b>AML<\/b>&#8220;). We also established Lung Cancer Precision Alliance (&#8220;<b>LCPA<\/b>&#8220;) with top pharmaceutical companies including BeiGene &amp; Merck, which is the industry&#8217;s first alliance focusing on rare targets in the NSCLC field, in order to maximize the RET testing rate in broader market.<\/p>\n<p>\u2013 We have strengthened partnership with National Pathology Quality Control Center (&#8220;<b>PQCC<\/b>&#8220;) to standardize testing process and improve testing accuracy, with number of participating hospitals continuously improving.<\/p>\n<p>\u2013 We have continued to provide support to NSCLC\/MTC patients for RET mutation testing and to AML patients for IDH1 mutation testing, covering approximately 1,200 patients since the program was launched.<\/p>\n<ul type=\"disc\">\n<li><b> Established broad industry and academic awareness of our brand and scientific leadership<\/b><\/li>\n<\/ul>\n<p>\u2013 GAVRETO\u00ae (pralsetinib), AYVAKIT\u00ae (avapritinib) and TIBSOVO\u00ae (ivosidenib) were included in 21 of <span class=\"xn-location\">China&#8217;s<\/span> national guidelines for testing and treatment in multiple therapeutic areas, such as NSCLC, TC, GIST, SM, and AML, etc. In particular, the 2023 CSCO NSCLC guideline, the 2022 CSCO GIST Guidelines, the 2022 Chinese Guideline for Diagnosis and Treatment of Systemic Mastocytosis in Adults, and the 2022 China Anti Cancer Association (&#8220;<b>CACA<\/b>&#8220;) Hematological Oncology Guideline, etc.<\/p>\n<p>\u2013 We are in close collaboration with several industry associations \u2013 Chinese Society of Clinical Oncology (&#8220;<b>CSCO<\/b>&#8220;), CACA, Chinese Medical Association, Chinese Medical Doctor Association, etc., \u2013 on diagnosis and treatment standardization projects for GIST, NSCLC, MTC and hematological malignancies, further strengthening our industry connections and demonstrating our expertise.<\/p>\n<p>\u2013 We initiated or supported investigators in post-approval clinical projects, such as investigator-initiated trials (&#8220;<b>IIT<\/b>&#8220;) and real-world studies (&#8220;<b>RWS<\/b>&#8220;), to generate additional data in multiple cancer indications. For example, a multi-centered RWS evaluated the safety and efficacy of AYVAKIT\u00ae (avapritinib) in Chinese patients with GIST; another IIT aims to study the efficacy and safety profile of AYVAKIT\u00ae (avapritinib) for the treatment of R\/R AML with KIT D816 or N822 mutations.<\/p>\n<ul type=\"disc\">\n<li><b> Developing a range of approaches to promote accessibility and affordability of our drugs<\/b><\/li>\n<\/ul>\n<p>\u2013 We have updated our pricing strategy for our in-market products. Specifically, the patient assistance program (&#8220;<b>PAP<\/b>&#8220;) scheme for GAVRETO\u00ae (pralsetinib) was updated to lower the barrier for some patients with low affordability and improve price competitiveness. We also launched a new PAP for AYVAKIT\u00ae (avapritinib) to support the long-term treatment for GIST patients. We adjusted the PAP scheme for TIBSOVO\u00ae (ivosidenib) to increase affordability and duration of treatment (&#8220;<b>DOT<\/b>&#8220;).<\/p>\n<p>\u2013 We secured inclusion of AYVAKIT\u00ae (avapritinib), GAVRETO\u00ae (pralsetinib) and TIBSOVO\u00ae (ivosidenib) in 138 of the major commercial and government insurance programs in all major areas such as <span class=\"xn-location\">Beijing<\/span>, <span class=\"xn-location\">Shanghai<\/span>, <span class=\"xn-location\">Guangdong<\/span>, <span class=\"xn-location\">Zhejiang<\/span>, and <span class=\"xn-location\">Shandong<\/span>, etc., covering a population of approximately 100 million.<\/p>\n<p>\u2013 We continued strategic collaboration with Sinopharm Group Co., Ltd (&#8220;<b>Sinopharm<\/b>&#8220;) and formed a new partnership with Shanghai Pharmaceuticals Holding Co., Ltd (&#8220;<b>SPH<\/b>&#8220;) to broaden hospital and pharmacy distribution coverage for GAVRETO\u00ae (pralsetinib), AYVAKIT\u00ae (avapritinib) and TIBSOVO\u00ae (ivosidenib). As of the date of this announcement, AYVAKIT\u00ae (avapritinib), GAVRETO\u00ae (pralsetinib) and TIBSOVO\u00ae (ivosidenib) have been listed in approximately 300 hospitals and direct-to-patient pharmacies (&#8220;<b>DTPs<\/b>&#8220;), up from approximately 220 in 2022.<\/p>\n<p><b>\u2022 Continued patient education and support to improve retention and DOT<\/b><\/p>\n<p>We made continuous efforts in patient support via online patient communities and offline education sessions to improve patient retention and DOT. As of the date of this announcement, our online platform has over 8,000 subscribers and has published over 330 patient stories since launch. Moreover we have held approximately 200 patient education sessions, covering 20,000 potential patients.<\/p>\n<ul type=\"disc\">\n<li><b> Collaborating with Pfizer on the commercialization of sugemalimab in <span class=\"xn-location\">China<\/span><\/b><\/li>\n<\/ul>\n<p>\u2013 We are closely collaborating with our partner Pfizer on the commercialization of sugemalimab in mainland <span class=\"xn-location\">China<\/span>.<\/p>\n<p>\u2013 In 2023, sugemalimab as a treatment of stage III NSCLC has been upgraded to a Level 1 recommendation in the 2023 CSCO NSCLC guideline and the 2023 CSCO Immunotherapy guideline. In addition, sugemalimab has been included in the 2023 clinical practice guideline for stage IV primary lung cancer in <span class=\"xn-location\">China<\/span>.<\/p>\n<p><b>II. Innovation, High Quality and Rapid Execution Lead to Advances across an Evolving Pipeline<\/b><\/p>\n<p>Details are as follows:<\/p>\n<ul type=\"disc\">\n<li><b>Sugemalimab<\/b> (CS1001, PD-L1 antibody), new indications under review and expanding to <span class=\"xn-location\">Europe<\/span> and the U.K.<\/li>\n<\/ul>\n<p>\u2013 <b>Stage IV NSCLC<\/b>:<\/p>\n<ul type=\"disc\">\n<li>For the markets outside of <span class=\"xn-location\">Greater China<\/span>, the marketing authorization application (&#8220;<b>MAA<\/b>&#8220;) for stage IV NSCLC indication is under review by the regulatory agencies in multiple countries and regions. In <span class=\"xn-chron\">February 2023<\/span> and <span class=\"xn-chron\">December 2022<\/span>, the MAA filing for sugemalimab in combination with chemotherapy as the first-line treatment for patients with metastatic NSCLC was accepted by the EMA in the E.U. and the Medicines and Healthcare products Regulatory Agency (&#8220;<b>MHRA<\/b>&#8220;) in the U.K. respectively. Currently, this indication is under review by both parties. In <span class=\"xn-chron\">July 2023<\/span>, we received the GCP inspection notification from EMA for this indication in the E.U.<\/li>\n<li>In <span class=\"xn-chron\">June 2023<\/span>, we announced that the results of Overall Survival (&#8220;<b>OS<\/b>&#8220;) interim analysis in the registrational GEMSTONE-302 study in patients with stage IV NSCLC were published in a world-renowned oncology journal \u2013 Nature Cancer.<\/li>\n<\/ul>\n<p>\u2013 <b>GC\/GEJ<\/b>:<\/p>\n<ul type=\"disc\">\n<li>In <span class=\"xn-chron\">February 2023<\/span>, we received the NDA acceptance from the NMPA for the first-line treatment of patients with locally advanced or metastatic GC\/GEJ.<\/li>\n<\/ul>\n<p>\u2013 <b>ESCC<\/b>:<\/p>\n<ul type=\"disc\">\n<li>In <span class=\"xn-chron\">April 2023<\/span>, we received the NDA acceptance from the NMPA for the first-line treatment of patients with unresectable locally advanced, recurrent, or metastatic ESCC.<\/li>\n<li>In <span class=\"xn-chron\">January 2023<\/span>, we announced that the GEMSTONE-304 study for the first- line treatment of unresectable locally advanced, recurrent, or metastatic ESCC has met its primary endpoints. Sugemalimab in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (&#8220;<b>PFS<\/b>&#8220;) and OS compared with placebo in combination with chemotherapy. We presented the detailed results at the ESMO GI Congress in <span class=\"xn-chron\">June 2023<\/span>.<\/li>\n<\/ul>\n<p>\u2013 <b>R\/R ENKTL<\/b>:<\/p>\n<ul type=\"disc\">\n<li>In <span class=\"xn-chron\">March 2023<\/span>, we announced that the results of the registrational GEMSTONE-201 study in patients with R\/R ENKTL were published in a top-tier oncology journal \u2013 Journal of Clinical Oncology.<\/li>\n<\/ul>\n<ul type=\"disc\">\n<li><b>Pralsetinib <\/b>(CS3009, RET inhibitor)<\/li>\n<\/ul>\n<p>\u2013 In <span class=\"xn-chron\">January 2023<\/span>, we received the NDA approval from the Taiwan Food and Drug Administration (&#8220;<b>TFDA<\/b>&#8220;) for the treatment of patients with RET fusion-positive locally advanced or metastatic NSCLC, and advanced or metastatic RET-mutant MTC and RET fusion-positive TC.<\/p>\n<p>\u2013 In <span class=\"xn-chron\">June 2023<\/span>, we received the NDA approval from the NMPA for the first-line treatment of patients with RET fusion-positive locally advanced or metastatic NSCLC who have not been previously treated with systemic therapy.<\/p>\n<p>\u2013 In <span class=\"xn-chron\">June 2023<\/span>, we published updated results from the phase I\/II ARROW trial in Chinese patients with RET fusion-positive NSCLC in Cancer.<\/p>\n<ul type=\"disc\">\n<li><b>CS5001 <\/b>(LCB71, ROR1 ADC)<\/li>\n<\/ul>\n<p>\u2013 The global FIH study of this potential best-in-class (&#8220;<b>BIC<\/b>&#8220;) ROR1 ADC has shown swift recruitment to the dose-escalation part in the U.S. and <span class=\"xn-location\">Australia<\/span> with good safety and tolerability demonstrated. This multi-regional clinical trial has now expanded to include <span class=\"xn-location\">China<\/span>, further accelerating the development of this product. As one of the most advanced ROR1 ADCs in clinical development, CS5001 has therapeutic potential for various hematological and solid malignancies.<\/p>\n<p>\u2013 CS5001 has many distinctive features, including proprietary site-specific conjugation, tumor-cleavable linker, and prodrug technology. CS5001 demonstrated a BIC potential in mantle cell lymphoma and triple negative breast cancer xenograft models compared to a benchmark ROR1 ADC. In addition, CS5001 demonstrated a bystander effect in in vitro co-culture systems, suggesting that solid tumors with heterogeneous\/low expression of ROR1 may also benefit. In <span class=\"xn-chron\">March 2023<\/span>, we presented the translational data of CS5001 in an oral session at the 13th world ADC London conference (&#8220;<b>World ADC London<\/b>&#8220;).<\/p>\n<p>\u2013 In addition, we have identified a promising candidate ROR1 antibody clone for immuno-histochemistry (&#8220;<b>IHC<\/b>&#8220;) to enable biomarker-driven patient selection based on tumor ROR1 expression, supporting precision medicine efforts in the future.<\/p>\n<ul type=\"disc\">\n<li><b> Ivosidenib <\/b>(CS3010, IDH1 inhibitor)<\/li>\n<\/ul>\n<p>\u2013 In <span class=\"xn-chron\">January 2023<\/span>, we completed the <span class=\"xn-location\">China<\/span> bridging study of ivosidenib in R\/R AML patients.<\/p>\n<p>\u2013 In <span class=\"xn-chron\">May 2023<\/span>, we reached alignment with CDE on the regulatory pathway toward full approval of ivosidenib as a treatment for R\/R AML, and application dossiers are currently under preparation.<\/p>\n<ul type=\"disc\">\n<li><b> Avapritinib <\/b>(CS3007, KIT\/PDGFRA inhibitor)<\/li>\n<\/ul>\n<p>\u2013 In <span class=\"xn-chron\">May 2023<\/span>, our partner, Blueprint Medicines, received NDA approval from the U.S. Food and Drug Administration (&#8220;<b>FDA<\/b>&#8220;) for the treatment of adults with indolent systemic mastocytosis.<\/p>\n<p>\u2013 In <span class=\"xn-chron\">June 2023<\/span>, we presented new data of avapritinib in patients with advanced GIST at the American Society of Clinical Oncology (&#8220;<b>ASCO<\/b>&#8220;) Annual Meeting 2023.<\/p>\n<ul type=\"disc\">\n<li><b> Lorlatinib <\/b>(ALK\/ROS-1 inhibitor)<\/li>\n<\/ul>\n<p>\u2013 We are working with Pfizer to jointly develop lorlatinib in <span class=\"xn-location\">Greater China<\/span> and conducting a pivotal study in patients with ROS1-positive advanced NSCLC. In <span class=\"xn-chron\">June 2023<\/span>, we completed the patient enrollment for this study.<\/p>\n<p><b>III. Building out Research Pipeline Leveraging Multiple Sources of Innovation<\/b><\/p>\n<p>Precision medicines and immuno-oncology combinations remain our strategic focus. ADCs which deliver cytotoxic agents to tumors with precision, and multi-specific biologics which can create new biology and combinations represent two near-term modalities for early development.<\/p>\n<p>We have made significant progress in the first half of 2023 with several initiatives:<\/p>\n<ul type=\"disc\">\n<li><b>First-in-Class (&#8220;FIC&#8221;) ADCs:<\/b> Two <span class=\"xn-person\">FIC ADC<\/span> programs are progressing toward preclinical candidate (&#8220;<b>PCC<\/b>&#8220;) nomination, including one where a novel tumor-associated antigen which is expressed in multiple large tumor indications was identified using an in-house machine-learning bioinformatic algorithm. Candidate antibodies have been selected, and the conjugated lead molecules have demonstrated encouraging in vitro potency and in vivo efficacy. Investigational new drug applications (&#8220;<b>INDs<\/b>&#8220;) are expected to be filed in 2024 or 2025.<\/li>\n<li><b>I\/O multi-specifics:<\/b> CS2009, which is a tri-specific molecule against PD-1, VEGF plus another I\/O target, is under cell line development. IND is expected to be filed in 2024. Additionally, two other I\/O multi-specific programs are progressing through IND-enabling and PCC selection phases, respectively.<\/li>\n<li><b>Cell penetrating therapeutic platform:<\/b> Numerous well-known oncology targets are intracellular proteins deemed undruggable by current therapeutic approaches. We are developing a proprietary CPT platform against these otherwise intractable targets. Significant progress has been made in the development of this platform with broad therapeutic potential for oncology and beyond. We have obtained in vitro PoC using this platform for three treatment modalities thus far and observed drug-like in vivo pharmacokinetics as well as tumor bio-distribution.<\/li>\n<\/ul>\n<p><b>IV. Strategic Relationships Advance Commercialization Activities and Pipeline Development<\/b><\/p>\n<p>We continue to grow and deepen relationships with key global strategic partners to expand commercialization of our in-market and late-stage drugs, bolster our early-stage pipeline of potential FIC\/BIC molecules, and access technologies that complement our research and development efforts.<\/p>\n<p>On <span class=\"xn-chron\">February 22, 2023<\/span>, Blueprint Medicines announced that they will regain global commercialization and development rights to pralsetinib from Roche, excluding <span class=\"xn-location\">Greater China<\/span>. The transition is scheduled to be completed in <span class=\"xn-chron\">February 2024<\/span>, and Blueprint Medicines has initiated a process to re-partner pralsetinib outside of <span class=\"xn-location\">Greater China<\/span>. We are currently working together with Roche and Blueprint Medicines to take necessary steps to ensure continuity of supply of pralsetinib for patients in <span class=\"xn-location\">Greater China<\/span>.<\/p>\n<p>Under our partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd. (&#8220;<b>Hengrui<\/b>&#8220;) for anti-CTLA-4 mAb (CS1002), a phase Ib\/II trial of CS1002 combination therapy for the treatment of advanced solid tumors including HCC and NSCLC is being conducted by Hengrui.<\/p>\n<p>We regained rights for the development and commercialization of sugemalimab and nofazinlimab outside of <span class=\"xn-location\">Greater China<\/span>, with the termination of the License Agreement for sugemalimab and nofazinlimab between CStone and EQRx on <span class=\"xn-chron\">May 9, 2023<\/span>. The transition has been completed in <span class=\"xn-chron\">August 2023<\/span>. Currently, we are leading the regulatory process for sugemalimab MAA reviews by the EMA and the U.K. MHRA. The termination of this License Agreement will not affect the upfront and milestone payments previously received from EQRx. We are currently exploring potential partnership opportunities for both sugemalimab and nofazinlimab outside of <span class=\"xn-location\">Greater China<\/span>.<\/p>\n<p><b>V. Other Business Updates<\/b><\/p>\n<p><b>Manufacturing.<\/b>&nbsp;We are also in the process of technology transfer for multiple imported products which is expected to reduce costs and improve long-term profitability of our products. Specifically, the application relating to technology transfer for avapritinib is under review by the CDE. At the same time, the technology transfer for pralsetinib is proceeding smoothly, and a BE study has been initiated.<\/p>\n<p><b>FUTURE AND OUTLOOK<\/b><\/p>\n<p>We are working to bring a number of significant clinical and commercial developments to fruition that will be catalysts for our growth in the next twelve months.<\/p>\n<p>A detailed breakdown of expected developments for the next twelve months is set forth as below.<\/p>\n<p><b>Commercial Developments<\/b><\/p>\n<p>Our commercial team is working rapidly to expand the addressable market for our products and maximize their commercial potential with a focus on the following:<\/p>\n<ul type=\"disc\">\n<li>Improving market coverage by maximizing deployment effectiveness and leveraging digital platform<\/li>\n<li>Improving diagnosis rate and accuracy via deep collaboration with diagnostic companies, industry associations (e.g. PQCC), patient platforms and big data companies<\/li>\n<li>Strengthening branding and scientific leadership by leveraging the inclusion of guidelines, holding academic activities, and conducting post-approval clinical projects with focus on differentiation in clinical and safety profile<\/li>\n<li>Strengthening accessibility with continued efforts in hospitals and DTPs listing<\/li>\n<li>Improving affordability through pricing strategy optimization and commercial insurance\/ innovative payment plans<\/li>\n<li>Enhancing patient education and support through patient community engagement, education sessions and follow-ups leveraging digital platform<\/li>\n<\/ul>\n<p><b>Research &amp; Development<\/b><\/p>\n<p><b>NDA approvals expected:<\/b><\/p>\n<ul type=\"disc\">\n<li>Sugemalimab: NDA approval for R\/R ENKTL in mainland <span class=\"xn-location\">China<\/span> by the end of 2023<\/li>\n<li>Sugemalimab: MAA approval for the first-line treatment in stage IV NSCLC in the E.U. in the first half of 2024<\/li>\n<li>Sugemalimab: MAA approval for the first-line treatment in stage IV NSCLC in the U.K. in the first half of 2024<\/li>\n<li>Sugemalimab: NDA approval for the first-line treatment in advanced GC\/GEJ in mainland <span class=\"xn-location\">China<\/span> in late 2023 or the first half of 2024<\/li>\n<li>Sugemalimab: NDA approval for the first-line treatment in advanced ESCC in mainland <span class=\"xn-location\">China<\/span> in late 2023 or the first half of 2024<\/li>\n<\/ul>\n<p><b>NDA filing expected:<\/b><\/p>\n<ul type=\"disc\">\n<li>Lorlatinib: supplemental NDA filing in mainland <span class=\"xn-location\">China<\/span> for ROS1-positive advanced NSCLC in 2024<\/li>\n<\/ul>\n<p><b>Topline readouts expected:<\/b><\/p>\n<ul type=\"disc\">\n<li>Sugemalimab: topline readout of the pre-specified OS final analysis in the GEMSTONE-303 study of sugemalimab in combination with chemotherapy for the first-line treatment of patients with advanced GC\/GEJ in the third quarter of 2023<\/li>\n<li>Nofazinlimab: topline readout of the global phase III trial of nofazinlimab in combination with LENVIMA\u00ae (lenvatinib) for the first-line treatment of patients with advanced HCC in the first quarter of 2024<\/li>\n<\/ul>\n<p><b>Early clinical programs:<\/b><\/p>\n<ul type=\"disc\">\n<li>CS5001: update on clinical safety and efficacy by the end of 2023 and conference presentation in the first half of 2024<\/li>\n<\/ul>\n<p><b>Financial highlights<\/b><\/p>\n<p><b>International Financial Reporting Standards (&#8220;IFRS&#8221;) Measures:<\/b><\/p>\n<ul type=\"disc\">\n<li><b>Revenue<\/b> was <span class=\"xn-money\">RMB 261.5 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>, composed of <span class=\"xn-money\">RMB 246.9 million<\/span> in sales of pharmaceutical products (avapritinib, pralsetinib and ivosidenib) and <span class=\"xn-money\">RMB14.6 million<\/span> in royalty income of sugemalimab, representing an increase of pharmaceutical products sales of <span class=\"xn-money\">RMB85.5 million<\/span>, or 53%, from <span class=\"xn-money\">RMB161.4 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span> and an increase of royalty income of <span class=\"xn-money\">RMB1.5 million<\/span>, or 11%, from <span class=\"xn-money\">RMB13.1 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span>.<\/li>\n<li><b> Research and development expenses<\/b> were <span class=\"xn-money\">RMB186.8 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>, representing a decrease of <span class=\"xn-money\">RMB79.8 million<\/span> from <span class=\"xn-money\">RMB266.6 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span>, primarily due to the decrease in milestone fee and third party contracting costs and the decrease in employee costs.<\/li>\n<li><b> Administrative expenses <\/b>were <span class=\"xn-money\">RMB89.2 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>, representing a decrease of <span class=\"xn-money\">RMB 45.6 million<\/span> from <span class=\"xn-money\">RMB134.8 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span>, primarily due to the decrease in employee costs.<\/li>\n<li><b>Selling and marketing expenses <\/b>were <span class=\"xn-money\">RMB131.4 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>, representing a decrease of <span class=\"xn-money\">RMB15.0 million<\/span> from <span class=\"xn-money\">RMB146.4 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span>, primarily attributable to the decrease in employee costs and professional fees.<\/li>\n<li><b> Loss for the period<\/b> was <span class=\"xn-money\">RMB 209.2 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>, representing a decrease of <span class=\"xn-money\">RMB152.4 million<\/span>, or 42%, from <span class=\"xn-money\">RMB361.6 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span>, primarily attributable to the decrease in research and development expenses and decrease in employee costs.<\/li>\n<\/ul>\n<p><b>Non-International Financial Reporting Standards (&#8220;Non-IFRS&#8221;) Measures:<\/b><\/p>\n<ul type=\"disc\">\n<li><b>Research and development expenses<\/b> excluding the share-based payment expenses were <span class=\"xn-money\">RMB198.1 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>, representing a decrease of <span class=\"xn-money\">RMB20.8 million<\/span> from <span class=\"xn-money\">RMB218.9 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span>, primarily due to the decrease in milestone fee and third party contracting costs and the decrease in employee costs.<\/li>\n<li><b>Administrative and selling and marketing expenses<\/b> excluding the share-based payment expenses were <span class=\"xn-money\">RMB183.1 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>, representing a decrease of <span class=\"xn-money\">RMB41.3 million<\/span> from <span class=\"xn-money\">RMB224.4 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span>, primarily attributable to the decrease in employee costs and professional fees.<\/li>\n<li><b>Loss for the period<\/b> excluding the share-based payment expenses was <span class=\"xn-money\">RMB183.0 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2023<\/span>, representing a decrease of <span class=\"xn-money\">RMB74.1 million<\/span>, or 29%, from <span class=\"xn-money\">RMB257.1 million<\/span> for the six months ended <span class=\"xn-chron\">June 30, 2022<\/span>, primarily attributable to the decrease in research and development expenses and the decrease in employee costs.<\/li>\n<\/ul>\n<p><b>About CStone<\/b><\/p>\n<p>CStone (HKEX: 2616) is a biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in <span class=\"xn-location\">China<\/span> and worldwide. Established in 2015, CStone has assembled a management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 14 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received eleven NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone&#8217;s vision is to bring innovative oncology therapies to cancer patients worldwide.<\/p>\n<p>For more information about CStone, please visit <a href=\"http:\/\/www.cstonepharma.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.cstonepharma.com<\/a>.<\/p>\n<p><b>Forward-looking statements<\/b><\/p>\n<p>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.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The total revenue was RMB 261.5 million for the six months ended June 30, 2023. The sales of pharmaceutical products revenue was RMB 246.9 million, representing a growth rate of 53% compared to the same period last year. Commercial gross profit margin improved from 47% to 59%. Healthy financial position with cash reserves of RMB [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-21196","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CStone Pharmaceuticals Reports 2023 Interim Results and Updates - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=21196\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"CStone Pharmaceuticals Reports 2023 Interim Results and Updates - My Blog\" \/>\n<meta property=\"og:description\" content=\"The total revenue was RMB 261.5 million for the six months ended June 30, 2023. 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