Recombinant Human Endostatin (Simcere)

NANJING, China, June 26, 2024 /PRNewswire/ -- On June 25, 2024, Simcere Zaiming, an innovative oncology company and a subsidiary of Simcere Pharmaceutical Group (2096.HK), announced that Enlituo® (generic name: cetuximab beta injection), a new generation anti-epidermal growth factor receptor (EGFR) antibody drug developed in collaboration with Mabpharm Limited (2181.HK), has recently received approval from the China National Medical Administration (NMPA) for marketing. Enlituo® is indicated for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). According to the 'Cancer Incidence and Mortality in China, 2022' by the National Cancer Center, colorectal cancer ranks as the second most common cancer in China. Annually, there are 1.571 million new cases and 240,000 deaths, imposing a substantial disease burden on the society. When colorectal cancer patients develop metastasis, the primary treatment options often include chemotherapy and targeted drugs. Previous clinical studies have demonstrated the effectiveness of EGFR-targeting antibody drugs in treating malignant tumors, particularly mCRC, in patients without RAS/BRAF mutations (wild-type). Enlituo® (cetuximab beta, originally known as CMAB009) is a recombinant EGFR monoclonal antibody developed independently in China. Classified as a 2.4 class modified biological new drug, cetuximab beta is prepared using a proprietary protein expression technique, effectively avoiding glycosylation modification that may lead to hypersensitivity. Enlituo® received approval based on robust evidence from a phase 2/3 study and a phase 3 confirmatory clinical trial. In an open-label, randomized, controlled, multicenter, prospective phase 3 study, 505 subjects with RAS/BRAF wild-type mCRC were treated and analyzed. Clinical data revealed that combining cetuximab beta with FOLFIRI significantly extended progression-free survival (PFS) compared to FOLFIRI alone (13.133 months vs. 9.567 months, P = 0.004). Additionally, the combination increased the objective response rate (ORR) (69.1% vs. 42.3%, P < 0.001) and overall survival (OS) (2.322 years vs. 1.900 years, P = 0.024). Dr. Renhong Tang, Chairman of Simcere Zaiming, emphasized Enlituo®'s unique clinical value in targeted therapy: "Its initial indication for colorectal cancer addresses a large patient population. The product synergizes well with Simcere Zaiming's existing offerings, and efforts are underway to accelerate its commercialization, benefiting more cancer patients." Dr. Hao Wang, Chief Executive Officer of Mabpharm, expressed excitement as Enlituo® bridged the gap in colorectal cancer treatment with domestically developed EGFR-targeted drugs. "This provides clinicians and patients with updated therapeutic options. By collaborating with Simcere Zaiming's Marketing Team, we are able to rapidly realize the clinical value of Enlituo®, benefiting hundreds of thousands of patients in China with an effective and affordable biological new drug. " Enlituo represents the first EGFR monoclonal antibody drug developed in China with independent intellectual property rights that are approved for the first-line treatment of mCRC. The successful launch of Enlituo® will provide high quality and affordable biological targeted remedy for Chinese cancer patients. In March 2023, the drug marketing application of Enlituo® was accepted by the NMPA. On August 18, 2023, the Group entered into a cooperation agreement with Mabpharm, pursuant to which the Group obtained the exclusive commercial rights in respect of Enlituo® in Chinese mainland. About Mabpharm Mabpharm (stock code: 2181) focuses on the development of monoclonal antibodies and has an experienced R&D team, multiple core technologies, leading domestic large-scale antibody preparation system and excellent quality control system. Mabpharm strives to bring high quality and affordable innovative biologics through its efficient R&D system and low-cost pharmaceutical production capability to the market, and develops various therapeutic products by fully utilizing its extensive R&D experience. About Simcere Zaiming Simcere Zaiming, an oncology-centric biopharmaceutical subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096), was established in 2023. The company is devoted to crafting groundbreaking therapies aimed at fulfilling the unmet clinical needs of cancer patients globally. With a robust and innovative R&D pipeline featuring distinct clinical assets, Simcere Zaiming has successfully launched several products in China, including COSELA®, Endostar®, and Envafolimab. The company is determined to deliver potentially transformative treatment options to cancer patients worldwide through its internal R&D, manufacturing, and commercialization capabilities, complemented by strategic collaborations with leading partners in the field of innovative cancer therapeutics. SOURCE Simcere

Just four months after Simcere Zaiming's founding, the organization is sharing details on targets and technologies, including two oral presentations BOSTON, April 13, 2023 /PRNewswire/ -- Simcere Zaiming (Company), a pharmaceutical company focused on developing drugs to address unmet clinical needs for cancer patients around the globe, and subsidiary of Simcere Pharmaceutical Group Limited (2096.HK) (Simcere), a global pharmaceutical company, today announced two oral and six poster presentations will be presented on the Company's preclinical programs at the 2023 American Association for Cancer Research (AACR) Annual Meeting, taking place April 14-19, 2023, in Orlando, FL. The AACR annual meeting is one of the most influential oncology conferences of the year and attracts tens of thousands of scientists and clinical experts to share and discuss the latest progress in basic research, translational research, clinical research and prevention research in the field of oncology. Today's announcement marks a significant milestone for the company as it will be the first time Simcere Zaiming will participate in an international academic conference as an independent oncology entity with multiple studies, including on-site oral presentations. The eight studies cover several targets including SMARCA2, CBL-b, Polθ, SOS1, MUC17, USP1, SIRPα, GPRC5D, and involve multiple novel technologies such as targeted protein degradation, mutant fusion proteins, bispecific T engager and others. Oral Presentations: Title: Identification of a high selective SMARCA2 degrader which effectively suppresses the SMARCA4-deficient tumors M vitro and in Wvo Session Type: Minisymposium Session Category: Experimental and Molecular Therapeutics Session Title: Innovative Therapeutic Approaches Session Date/Time: Sunday Apr 16, 2023 3:00 PM - 5:00 PM Location: Room W331 Abstract Presentation Number: 1137 Presenter: Dr. Zhengtao Li, Vice President, Simcere Zaiming Targeting the "synthetic lethal" partner proteins SMARCA2/4 (human chromatin SWI/SNF- Related, Matrix-Associated, actin-dependent regulatory factor subfamily A member 2 and 4), SCR-9140 selectively degrades SMARCA2 to precisely kill SMARCA4-deficient tumors in preclinical studies while preventing damage to normal cells, thus exhibiting strong antitumor efficacy and favorable safety profile. Title: Identification of the selective CBL-b inhibitors which effectively prevent T cells from exhaustion and demonstrate synergistic anti-tumor activity in combination with an anti-PD1 antibody Session Title: Immune Checkpoints at Tumor Beds Session Date/Time: Monday Apr 17, 2023 2:30 PM - 4:30 PM Abstract Presentation Number: 3474 Presenter: Dr. Tamas Oravecz, Senior Vice President, Chief Scientific Officer, Simcere Zaiming The E3 ubiquitin ligase CBL-b (Casitas B-cell lymphoma protein b) negatively regulates immune function and is considered a potential novel intracellular immune checkpoint. In preclinical studies, a group of Cbl-b inhibitor candidate drugs developed by Simcere Zaiming have demonstrated strong immune activation capabilities and synergistic effects with PD-1 inhibitors, suggesting strong potential for clinical application. Poster Presentations: Title: Identification of SS008871, a novel Polθ inhibitor that effectively inhibits tumors with homologous recombination deficiency in vitro and in vivo Session Title: Experimental and Molecular Therapeutics, Novel Antitumor Agents 2 Session Date and Time: Sunday Apr 16, 1:30 PM – 5:00 PM Location: Poster Section 18 Poster Board Number: 12 Abstract Number: 512 DNA polymerase θ (Polθ) is a key enzyme for DNA double-strand break repair and cell survival in homologous recombination-deficient tumors, and it is also a potential synthetic lethal new therapeutic target. The small molecule inhibitor of Pol θ, SS008871, has shown significant anti-tumor effect and good safety in various preclinical models. Title: SCR-8388, a potent and selective SOS1::KRAS inhibitor, is effective in KRAS-addicted cancers Session Title: Oncogenes and Tumor Suppressor, Genes as Targets for Therapy 2 Session Date and Time: Monday, Apr 17, 9 AM – 12:30 PM Location: Poster Section 20 Poster Board Number: 21 Abstract Number: 1724 The most common oncogene, KRAS, was once regarded as the most difficult drug target, and there was a large unmet clinical need. SCR-8388 is a selective SOS 1 protein inhibitor that acts on the upstream pathway of KRAS and prevents KRAS activation. Preclinical studies have shown that SCR-8388 can significantly inhibit the growth of KRAS mutant tumors in both in vitro and in vivo models, and has a synergistic effect with EGFR antagonists. Title: SCR-9171, a MUC17-targeted bispecific T cell engager molecule for gastrointestinal cancer Session Title: Immunology, Therapeutic Antibodies 1 Session Date and Time: Monday Apr 17, 9:00 AM - 12:30 PM Location: Poster Section 25 Poster Board Number: 21 Abstract Number: 1882 MUC17 is a transmembrane mucin that is often overexpressed in gastric cancer tissues and is also a potential target for gastric cancer therapy. SCR-9171 is a MUC17/CD3 bispecific T cell engager that precisely inhibits MUC17 expressing tumors with optimal CD3 affinity. In preclinical studies, SCR-9171 induces T cell activation, thereby potently killing MUC17-positive tumors, while releasing low level of cytokines that can lead to better treatment tolerability. Title: A novel T cell engager targeting BCMA and GPRC5D showed promising preclinical activity with low toxic risk for multiple myeloma treatment Session Title: Immunology, Therapeutic Antibodies 1 Session Date and Time: Monday Apr 17, 9:00 AM - 12:30 PM Location: Poster Section 25 Poster Board Number: 22 Abstract Number: 1883 SCR-8572, a T-cell engager developed against two specific targets in multiple myeloma, BCMA and GPRC5D, demonstrated potent tumor-killing effects in preclinical in vitro and in vivo models, with preliminary good safety results. It is expected to become a candidate drug for clinical development. Title: Identification of SP-002, a highly selective USP1 inhibitor effectively inhibits HRD tumor growth and displays low hematotoxicity risk Session Title: Experimental and Molecular Therapeutics, DNA Repair / Molecular Classification of Tumors for Diagnostics, Prognostics, and Therapeutic Outcomes / Others Session Date and Time: Wednesday Apr 19, 9:00 AM - 12:30 PM Location: Poster Section 18 Poster Board Number: 3 Abstract Number: 6201 USP1 (ubiquitin-specific peptidase 1) is a synthetic lethal protein of HRD (homologous recombination deficient) tumors. As a highly selective USP1 inhibitor, SP-002 has significant anticancer activity against HRD tumors as a single drug or in combination with PARP inhibitors in preclinical in vitro studies. Furthermore, no significant hematological toxicity was observed. Title: Generation of a mutant SIRPa fusion protein with highly-improved affinity and favorable safety profile Session Title: Immunology, Immune Checkpoints Session Date and Time: Wednesday Apr 19, 9:00 AM - 12:30 PM Location: Poster Section 23 Poster Board Number: 1 Abstract Number: 6357 Interaction of the transmembrane glycoprotein CD47 with signal regulatory protein alpha (SIRPα) triggers "don't eat me" signaling to the macrophage, thereby serving as a key immune checkpoint in a variety of hematological malignancies. SCR9168 is a SIRPα mutant protein fused with Fc, which has significantly improved CD47 affinity, and has good safety in various animal models including cynomolgus monkeys and has best-in-class potential of SIRPα mutant protein in the treatment of hematological tumors. About Simcere Zaiming Simcere Zaiming is a pharmaceutical company specializing in oncology, and a subsidiary of Simcere Pharmaceutical Group Limited, that focuses on the R&D, production and commercialization of innovative cancer therapeutics. The company was formed in 2023 and is committed to solving unmet clinical needs for cancer patients in China and around the world by developing breakthrough treatments. Simcere Zaiming has an innovative R&D pipeline with differentiated clinical value, among which 15 assets are currently in clinical trials. In addition to the company's R&D portfolio, Simcere Zaiming is marketing three innovative drugs, COSELA®, Endostar®, and Envafolimab®. By collaborating with partners globally, Simcere Zaiming strives to bring potentially new innovative therapeutics to cancer patients worldwide. Media Contact: [email protected] About Simcere Pharmaceutical Group Simcere Pharmaceutical Group Limited (2096.HK) is an innovation and R&D-driven pharmaceutical company. The Company focuses on three therapeutic areas, oncology, central nervous system and autoimmune diseases, with a forward-looking vision toward disease areas that may have significant clinical needs in the future, aiming to achieve the mission of "providing today's patients with medicines of the future." Leveraging its R&D capability and commercialization excellence, Simcere has built a market-leading product portfolio in China. Its vigorous in-house R&D efforts and extensive R&D and commercial stage collaborations have made it a strategic alliance partner with world-leading innovative companies and research institutes. For more information, please visit: Media Contact: [email protected] Tyler Gagnon Simcere Pharmaceutical Group Limited Director, Corporate Communications & Public Affairs [email protected] SOURCE Simcere Zaiming