Trilaciclib Dihydrochloride

Ipsen gains exclusive global rights, outside of Greater China, for development, manufacturing and commercialization of SIM0613, a LRRC15-targeting antibody-drug conjugateSIM0613 is optimally designed for superior tumor penetration with robust preclinical efficacy dataProgram expected to enter Phase I clinical development in H2 2026Simcere Zaiming is eligible to receive up to $1.06B in total payments PARIS, FRANCE; 22 DECEMBER 2025 - Ipsen (Euronext: IPN; ADR: IPSEY) announced today an exclusive licensing agreement for global rights outside of Greater China, for SIM0613, an antibody-drug conjugate (ADC) with best-in-class potential. Targeting the LRRC15 protein, SIM0613 is designed for enhanced tumor penetration and differentiated anti-tumor activity in solid tumors with the highest unmet needs. “Today’s announcement underscores our bold vision to lead innovation and shape the future of oncology,” said Christelle Huguet, PhD EVP and Head of Research & Development, Ipsen. “By advancing first- and best-in-class therapies early, we maximize the potential to transform patient outcomes globally. The addition of the SIM0613 ADC is testament to this ambition—pioneering science that opens new possibilities for those who need it most and builds on Ipsen’s rapidly evolving research and early development portfolio, with over 20 programs added since 2020." "SIM0613 is developed via Simcere Zaiming's proprietary antibody-drug conjugate platform," said Renhong Tang, PhD, CEO of Simcere Zaiming. "We are excited to partner with Ipsen on this novel drug candidate and look forward to working together to advance the clinical development of SIM0613. " Under the terms of the agreement, Simcere Zaiming is eligible to receive up to $1.06B comprising upfront, development, regulatory and commercial milestone payments, and tiered royalties on sales, contingent upon successful development and regulatory approvals. Ipsen will have manufacturing rights, following the tech transfer process and will assume responsibility for all activities outside Greater China including Phase I preparation activities and submission of the Investigational New Drug and Clinical Trial applications. About SIM0613SIM0613 targets the leucine-rich repeat-containing 15 (LRRC15), a protein highly expressed on varies tumor types and cancer-associated fibroblasts but with limited expression on normal cells. Upon binding to the LRRC15 protein, SIM0613 is internalized where the cytotoxic payload is released, killing the cancer cell and therefore sparing healthy cells. SIM0613 is specifically engineered for deep tumor and cancer-associated fibroblast penetration, resulting in robust tumor regressions in multiple in vivo preclinical models. About IpsenWe are a global biopharmaceutical company with a focus on bringing transformative medicines to patients in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Our pipeline is fueled by internal and external innovation and supported by nearly 100 years of development experience and global hubs in the U.S., France and the U.K. Our teams in more than 40 countries and our partnerships around the world enable us to bring medicines to patients in more than 100 countries. Ipsen is listed in Paris (Euronext: IPN) and in the U.S. through a Sponsored Level I American Depositary Receipt program (ADR: IPSEY). For more information, visit ipsen.com. About Simcere ZaimingSimcere Zaiming is an oncology-focused bipharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Limited (HKEX: 2096, “Simcere”). Founded in 2023, Simcere Zaiming dedicated to developing ground breaking therapies to meet 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 innovative products in China, including Enzeshu®, COSELA®, Enweida®, Endostar®, and Enlituo®. 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. About antibody-drug-conjugatesAntibody-Drug Conjugates are comprised of three main components: the antibody, a payload and a linker. The antibody selectively targets an identified tumor antigen. Payloads are the pharmaceutically active component to treat the cancer, attached to the antibody via a chemical linker. The linker connects the antibody and the payload and reduces the amount of payload that reaches non-tumor tissue. Ipsen ContactsInvestorsHenry Wheeler henry.wheeler@ipsen.com +33 7766471149Khalid Deojee khalid.deojee@ipsen.com +33 666019526 MediaSally Bain sally.bain@ipsen.com +1 8573200517Anne Liontas anne.liontas.ext@ipsen.com +33 0767347296 Disclaimers and/or forward-looking statements The forward-looking statements, objectives and targets contained herein are based on Ipsen’s management strategy, current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. All of the above risks could affect Ipsen’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. Use of the words ‘believes’, ‘anticipates’ and ‘expects’ and similar expressions are intended to identify forward-looking statements, including Ipsen’s expectations regarding future events, including regulatory filings and determinations. Moreover, the targets described in this document were prepared without taking into account external-growth assumptions and potential future acquisitions, which may alter these parameters. These objectives are based on data and assumptions regarded as reasonable by Ipsen. These targets depend on conditions or facts likely to happen in the future, and not exclusively on historical data. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably the fact that a promising medicine in early development phase or clinical trial may end up never being launched on the market or reaching its commercial targets, notably for regulatory or competition reasons. Ipsen must face or might face competition from generic medicine that might translate into a loss of market share. Furthermore, the research and development process involves several stages each of which involves the substantial risk that Ipsen may fail to achieve its objectives and be forced to abandon its efforts with regards to a medicine in which it has invested significant sums. Therefore, Ipsen cannot be certain that favorable results obtained during preclinical trials will be confirmed subsequently during clinical trials, or that the results of clinical trials will be sufficient to demonstrate the safe and effective nature of the medicine concerned. There can be no guarantees a medicine will receive the necessary regulatory approvals or that the medicine will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Other risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and healthcare legislation; global trends toward healthcare cost containment; technological advances, new medicine and patents attained by competitors; challenges inherent in new-medicine development, including obtaining regulatory approval; Ipsen’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Ipsen’s patents and other protections for innovative medicines; and the exposure to litigation, including patent litigation, and/or regulatory actions. Ipsen also depends on third parties to develop and market some of its medicines which could potentially generate substantial royalties; these partners could behave in such ways which could cause damage to Ipsen’s activities and financial results. Ipsen cannot be certain that its partners will fulfil their obligations. It might be unable to obtain any benefit from those agreements. A default by any of Ipsen’s partners could generate lower revenues than expected. Such situations could have a negative impact on Ipsen’s business, financial position or performance. Ipsen expressly disclaims any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this press release to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based, unless so required by applicable law. Ipsen’s business is subject to the risk factors outlined in its registration documents filed with the French Autorité des Marchés Financiers. The risks and uncertainties set out are not exhaustive and the reader is advised to refer to Ipsen’s latest Universal Registration Document, available on ipsen.com. Attachment Ipsen PR_Simcere Zaiming_22122025

MORRISTOWN, NJ, UNITED STATES, December 7, 2025 / EINPresswire.com / -- Pharmacosmos Therapeutics Inc. today announced the presentation of new investigator-sponsored research at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition. The abstract, titled “CDK4/6 inhibition mitigates chemotherapy-induced expansion of TP53-mutant clonal hematopoiesis” (Abstract #8419), was featured during a Plenary Scientific Session on Sunday, December 7 from 2:00–4:00 p.m. ET. The study, led by investigators from Washington University in St. Louis and Memorial Sloan Kettering Cancer Center, evaluated whether the intravenous CDK4/6 inhibitor trilaciclib may reduce the expansion of chemotherapy-associated TP53-mutant clonal hematopoiesis (CH), a known risk factor for therapy-related myeloid neoplasms (tMN). Pharmacosmos Therapeutics provided trilaciclib and blood samples from clinical trials with trilaciclib for use in this investigator-sponsored study but did not sponsor or conduct the research. The research showed that across three placebo-controlled trials involving patients with small cell lung cancer (SCLC), metastatic colorectal cancer (mCRC), and metastatic triple-negative breast cancer (mTNBC), administration of trilaciclib prior to chemotherapy was associated with a significantly lower rate of TP53-mutant CH clone expansion compared to placebo. In preclinical murine models, concomitant treatment with trilaciclib and carboplatin prevented expansion of p53-mutant hematopoietic stem cells, while preserving normal progenitor cells under cytotoxic stress. Principal investigator and senior author Kelly Bolton, MD, PhD from Washington University in St. Louis, described this trial as “the first time that an approach has been identified to reducing expansion of TP53-mutant CH during therapy. The data generated regarding trilaciclib’s role are emerging across multiple clinical contexts, consistently demonstrating a potential pattern of reduced TP53-mutant CH growth.” Additionally, co-corresponding author Omar Abdel-Wahab, MD from Memorial Sloan Kettering Cancer Center added that “therapy related myeloid neoplasms are a very troubling complication of cancer therapy. There are currently very limited effective treatments when therapy-related myeloid neoplasms occur. We are very excited about this study, as the results provide the first clue about a strategy to prevent the development of therapy-related myeloid neoplasms.” These data represent the first demonstration in patients of a pharmacologic strategy that may help limit chemotherapy-induced expansion of pre-leukemic TP53-mutant clones. Further studies are needed to confirm clinical significance. About Clonal Hematopoiesis and Therapy-Related Myeloid Neoplasms Clonal hematopoiesis (CH) refers to the presence of somatic mutations in hematopoietic stem or progenitor cells that confer a selective growth advantage, leading to clonal expansion with age or under genotoxic stress. Expansion of TP53-mutant clones has been linked to an increased risk of developing therapy-related myeloid neoplasms (tMN), a rare but serious late complication of prior cytotoxic therapy. Currently, there are no approved interventions to prevent CH expansion or reduce the risk of tMN. About COSELA ® (trilaciclib) COSELA ® (trilaciclib) is an intravenously administered cyclin-dependent kinase (CDK) 4/6 inhibitor approved by the U.S. Food and Drug Administration to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC). COSELA is not approved for reducing clonal hematopoiesis or preventing therapy-related myeloid neoplasms. The recommended dose of COSELA is 240 mg/m², administered as a 30-minute intravenous infusion completed within four hours prior to the start of chemotherapy. Important Safety Information CONTRAINDICATION COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib. WARNINGS AND PRECAUTIONS Injection-Site Reactions, Including Phlebitis And Thrombophlebitis COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients. Acute Drug Hypersensitivity Reactions COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA. Interstitial Lung Disease/Pneumonitis Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA. Embryo-Fetal Toxicity Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose. ADVERSE REACTIONS Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis. Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%). Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each). Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA. The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia. DRUG INTERACTIONS COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin). To report suspected adverse reactions, contact Pharmacosmos Therapeutics at 1-800-790-4189 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . This information is not comprehensive. Please see the full Prescribing Information. About Pharmacosmos Therapeutics We are a family-owned company innovating in iron metabolism, blood disorders, and cell cycle biology. With 700+ employees globally, we prioritize quality, collaboration, and patient care to drive life-changing treatments. Forward Looking Statement This press release includes forward-looking statements, including statements regarding the potential mechanism and investigational use of trilaciclib. Such statements are based on current expectations and assumptions and involve risks and uncertainties that may cause actual results to differ materially. COSELA ® (trilaciclib) is approved only to decrease the incidence of chemotherapy-induced myelosuppression in adults receiving certain regimens for extensive-stage small cell lung cancer. The effects of trilaciclib on clonal hematopoiesis or therapy-related myeloid neoplasms have not been established, and COSELA is not approved for these indications. Cory Steinberg Pharmacosmos Therapeutic, Inc. cos@pharmacosmos.us Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.