On January 16, 2025 IMPACT Therapeutics ("IMPACT"), a biopharmaceutical company focusing on the discovery and development of targeted anti-cancer therapeutics based on synthetic lethality, reported that Senaparib Capsules (派舒宁）has received marketing authorization in China from National Medical Products Administration (NMPA) as monotherapy for the maintenance treatment of adult patients with advanced epithelial (FIGO Stages III and IV) high-grade ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy (Press release, Impact Therapeutics, JAN 16, 2025, View Source [SID1234649759]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Senaparib, discovered and developed by IMPACT, is a potent and novel PARP 1/2 inhibitor. Its distinctive molecular structure provides it with high in vitro and in vivo activity, exceptional target selectivity and wide safety window. The approval is based on FLAMES Study. The study is a randomized, double-blind, placebo-controlled, multicenter, phase III clinical study to evaluate the efficacy and safety of Senaparib as monotherapy for the maintenance treatment of patients with advanced ovarian cancer who had completed first-line chemotherapy and achieved either a complete response (CR) or partial response (PR). The results of FLAMES Study showed that Senaparib demonstrated significant improvement in median PFS compared to placebo (PFS not reached vs 13.6 months, HR 0.43, P < 0.0001), irrespective of BRCA status. Senaparib demonstrated a tolerable safety profile, with no noticeable safety issues. [1]The results also indicated that both HRD positive and HRD negative populations derived benefit from Senaparib maintenance therapy, highlighting the potential of Senaparib for broad clinical application. The results of this study will strongly support Senaparib as the Standard of Care for first-line maintenance therapy in patients with newly diagnosed ovarian cancer.

The top-line results of the study were initially presented as a late breaking oral presentation at ESMO (Free ESMO Whitepaper) in 2023 and presented at CSCO 2024. On May 15, 2024, the internationally renowned medical journal Nature Medicine also published the results titled "Senaparib as first-line maintenance therapy in advanced ovarian cancer: a randomized phase 3 trial."[1]

Ovarian cancer is one of the most common lethal female reproductive malignancies. According to GLOBOCAN 2020 data, the global incidence of ovarian cancer is amounted to 310,000 cases and mortality is amounted to 210,000. According to the latest national cancer statistics released by National Cancer Center in 2024, there were 61,100 new cases of ovarian cancer and 32,600 deaths in China in 2022, making it the most lethal gynecological tumor. Due to the insidious and non-specific early symptoms of ovarian cancer, about 80% of patients are already in advanced stage when they are diagnosed, and the 5-year survival rate is only 41.8%. [2]Although ovarian cancer may be resolved after initial platinum-containing chemotherapy, most patients inevitably face recurrence, and there remains a significant unmet clinical need for treatment in the ovarian cancer patient population.

In recent years, PARP inhibitors are changing the therapeutic landscape of ovarian cancer, with maintenance therapy extending the duration of sustained remission after platinum-containing chemotherapy and delaying disease recurrence.

In December 2023, IMPACT entered into a collaboration agreement with Zhongmei Huadong Pharmaceutical Co., Ltd, a subsidiary of Huadong Medicine Co., Ltd (SZ.000963) (collectively, "Huadong Medicine") for the commercialization of Senaparib. Under the collaboration agreement, Huadong Medicine receives exclusive promotion rights of Senaparib in mainland China. Huadong Medicine is deeply involved in the field of gynecological oncology. Senaparib and Huadong Medicine’s approved mirvetuximab soravtansine-gynx (ELAHERE) can provide solutions for ovarian cancer patients with different stages of the disease, sharing expert networks, research and clinical resources, promoting and developing together to form an effective and highly synergistic relationship.

Dr. Sui Xiong Cai, Chief Executive Officer of IMPACT said:

"It is our great pleasure to share with you the successful approval of Senaparib for the Chinese market, which is another strong proof of the excellence of IMPACT’s in-house synthetic lethality R&D platform and the R&D execution team.

Leveraging Huadong Medicine’s extensive commercial experiences in promoting novel therapeutics, we hope that Senaparib will reach more ovarian cancer patients soon and bring new treatment options for first-line maintenance therapy in advanced ovarian cancer."

On January 16, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), reported that China’s National Medical Products Administration (NMPA) has approved the New Drug Application (NDA) of limertinib for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC) (Press release, Innovent Biologics, JAN 16, 2025, View Source [SID1234649760]). Limertinib is the 14th product in Innovent’s commercial portfolio and represents a cutting-edge addition to its strong TKI franchise, offering an innovative precision therapy option to lung cancer patients.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A Phase 2b pivotal study evaluating 301 patients with locally advanced or metastatic EGFR T790M-mutated NSCLC demonstrated limertinib’s robust efficacy and safety profile. Independent review committee（IRC） assessment showed an overall response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%. The median progression-free survival (PFS) reached 11.0 months, with a median duration of response (DoR) of 11.1 months. For patients with assessable central nervous system (CNS) lesions (N=99), the CNS best-ORR was 65.9% with a median PFS of 10.6 months. The safety profile aligned with other EGFR-targeting agents in its class.

Additionally, limertinib met its primary endpoint in a Phase 3 clinical trial comparing it to gefitinib for first-line treatment of locally advanced or metastatic NSCLC harboring EGFR mutations. A separate NDA for the first-line treatment in adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations is currently under NMPA review.

"Limertinib has demonstrated significant efficacy and safety in NSCLC patients with EGFR T790M mutation and EGFR-sensitive mutations. Patients treated with limertinib showed a reduced risk of CNS progression or death. This approval brings new hope and options to patients with advanced EGFR-mutated NSCLC in China," said Professor Shi Yuankai, MD, Department of Medical Oncology at Chinese Academy of Medical Sciences and Principal Investigator of the Phase 2b and Phase 3 clinical studies.

Dr. Hui Zhou, Senior Vice President of Innovent, stated："The approval of limertinib’s first indication marks a significant milestone, providing new treatment options for T790 mutation-positive lung cancer patients who have progressed after previous EGFR-TKI treatments. We anticipate the first-line treatment indication will benefit even more patients in the near future. As our 14th commercial product, limertinib represents an important advancement in precision medicine for lung cancer. We look forward to working with ASK Pharm to bring limertinib to market and benefit Chinese patients with EGFR-mutated NSCLC."

Mr. Jingfei Ma, CEO and Executive Director of ASK Pharm, stated: "Beyond the approval for EGFR T790M+ NSCLC, limertinib is also under regulatory review for first-line treatment of EGFR 19DEL+ or L858R+ NSCLC in China. ASKC202, a new highly selective c-Met inhibitor, is currently undergoing clinical study in combination with limertinib to treat patients with third-generation EGFR-TKI resistance. Together with Innovent, we look forward to limertinib benefiting more Chinese lung cancer patients in the near future. The first approval of limertinib, a Class I innovative product, represents significant progress in the company’s transformation toward innovative drug research and development. "

About EGFR mutation-positive non-small-cell lung cancer (NSCLC)

Lung cancer remains one of the deadliest and most common cancers globally[i], with NSCLC accounting for about 85% of cases. Around 70% of NSCLC patients are diagnosed at locally advanced or metastatic disease stages that cannot be surgically resected. EGFR mutations are particularly prevalent in Asian NSCLC patients, affecting 30% to 50% of cases. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability.

About Limertinib

Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, approved by the China’s NMPA for the treatment of adult patients with locally advanced or metastatic EGFR T790M-mutated non-small cell lung cancer (NSCLC). A second NDA is under NMPA review for first-line treatment of adult patients with locally advanced or metastatic NSCLC carrying EGFR exon 19 deletions or exon 21 L858R mutations.

The drug demonstrated success in a multi-center, randomized, double-blind, controlled Phase 3 clinical trial comparing its efficacy and safety of to gefitinib in first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. With the primary endpoint met, results will be presented at upcoming academic conferences or published in academic journals.

In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement for limertinib in Mainland China.

On January 16, 2025 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, reported to have participated in the 43rd Annual J.P. Morgan Healthcare Conference (Press release, Innovent Biologics, JAN 16, 2025, View Source [SID1234649761]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

During the conference, Dr. De-Chao Michael Yu, Founder, Chairman and CEO of Innovent, delivered a presentation highlighting 2025 as a pivotal year for significantly business growth and concreate steps in global innovation. These efforts will further strengthen the foundation for Innovent’s vision of becoming a global premier biopharma company.

Clear path to sustainable growth

Innovent has established itself as a leading brand in oncology, consistently gaining momentum with an expanding portfolio of synergistic products. Additionally, another key growth driver, the general biomedicine segment, features a highly competitive product lineup, poised to unlock the substantial opportunities in chronic disease areas.

The company remains confident in achieving its domestic product revenue target of 20 billion RMB by 2027. Alongside rapid business growth, Innovent continues to enhance operational efficiency through effective and lean management practices, ensuring sustainable and healthy operating model.

Focus on world-class technology platforms and key therapeutic areas

Innovent Academy, the company’s innovation engine, has built a world-class technology platform, encompassing ScFv engineering, T cell engager (TCE), VHH bispecific antibodies, Topo1i ADC, dual payload ADC, and antibody peptide conjugates (APC). These platforms have consistently delivered innovative molecules, providing a driving force for the company’s long-term development.

In particular, Innovent combines its world-class antibody engineering and multiple sets of differentiated linker payload technologies to create the TOPO1i ADC technology platform (SoloTx) and dual payload ADC technology platform (DuetTx), producing a pipeline of potential best-in-class (BIC) or first-in-class (FIC) ADC candidates.

The company has so far advanced 8 ADC candidates into clinic trials, supported by efficacy and safety data from over 600 patients, with multiple ADCs receiving breakthrough therapy designation (BTD). This further validates the differentiated advantage of the company’s ADC platform technology and its strong clinical execution.

Innovent continues to focus on high-potential therapeutic areas in oncology and general biomedicine. The "PD-1+precision therapies" pipeline strengthens its leadership in oncology, while the "IO+ADC" strategy is set to transform cancer treatment. Meanwhile, its general biomedicine pipeline covers next generation treatments for autoimmune, cardiovascular and metabolic, and ophthalmic diseases, aiming to elevate treatment standards for diverse patient populations.

Embracing new opportunities in global innovation

Innovent Academy’s advancements have paved the way for a globally competitive pipeline of next generation IO and ADC candidates. The company plans to expand into innovative ADCs, bispecific (multi-specific) antibodies, and next-generation autoimmune and CVM therapies for global development.

IBI343 (CLDN18.2 ADC): Phase 3 multi-regional clinical trial (MRCT) has been initiated in China and Japan for gastric cancer. Pancreatic cancer MRCT clinical Phase 1 data shows positive efficacy and safety signals in Chinese patients and has started patient enrollment in the U.S. Pivotal clinical trials are anticipated in 2025, subject to PoC validation.
IBI363：This first-in-class PD-1/IL-2α-biased bispecific antibody has shown promising Phase 1 clinical data, obtained from hundreds of patients in IO resistant non-small cell lung cancer (NSCLC), melanoma, and IO unresponsive "cold tumor" colorectal cancer (CRC). This points to its potential as the next generation IO cornerstone drug. Innovent is following up on the Phase 1b/2 expansion cohorts of these cancer types. Pivotal clinical studies in IO-resistant advanced squamous NSCLC and IO-naïve advanced melanoma are planned to launch in China in 2025, subject to PoC data and regulatory communication. A Phase 2 clinical study is ongoing in the U.S. and will further expand into cohorts for NSCLC, CRC, and melanoma.
IBI3009 (DLL3 ADC): Through global licensing collaboration with Roche, Innovent aims to accelerate the development of this potentially best-in-class DLL3 ADC for small cell lung cancer patients worldwide.
2025 outlook: unlocking growth opportunities

Looking ahead in 2025, the company anticipates a year of rapid growth, driven by six new drug launches and further advancements in commercialization across oncology and general biomedicine. Key highlights include:

Mazdutide (GCG/GLP-1): Expected approvals for weight loss and type 2 diabetes indications in the first and second half of 2025, respectively, will provide a best-in-class GCG/GLP-1 dual agonist drug offering robust weight loss and glucose reduction, substantial liver fat reduction as well as comprehensive metabolic benefits for the vast obese, overweight and diabetes population;
Teprotumumab (IGF-1R): Anticipated launch as China’s first anti-IGF-1R monoclonal antibody for thyroid eye disease (TED), addressing a 60-year treatment gap.
Picankibart (IL-23p19): Approval anticipated by late 2025. Picankibart is the first globally to report that over 80% of subjects achieved PASI 90 (≥90% improvement in psoriasis area and severity index) within 16 weeks of treatment. It also demonstrates clear advantages, including sustained long-term efficacy, effective in patients resistant to IL-17 inhibitors, and flexibility with seasonal dosing intervals. Picankibart is poised to deliver exceptional comprehensive benefits to psoriasis patients in China.
As the company advances key cornerstone products in its pipeline, we are actively expanding the development of mazdutide, teprotumumab, and picankibart into additional indications to maximize the portfolio’s value. Building on this solid foundation, next-generation candidates are gradually entering clinical development, aiming to address global challenges related to aging and chronic disease burden. These innovations focus on extending dosing intervals, oral delivery, and novel mechanisms of action.

Looking ahead to 2025, the company plans to submit NDAs or conduct ongoing registrational trials for seven drugs, while initiating pivotal or registrational trials for seven innovative pipeline candidates, pending PoC results. Additionally, molecules with global potential and novel mechanisms of action (MoAs) will progress into PoC and first-in-human studies. These efforts solidify Innovent’s vision of "growing into a global premier biopharma company."

On January 16, 2025 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported a strategic and multi-faceted collaboration with Ontada, a business dedicated to oncology real-world evidence, clinical education and point of care technologies, to advance molecular research and cancer care, enhance the healthcare delivery system and ultimately drive precision medicine by supporting life sciences companies in the development of next-gen oncology therapies (Press release, Caris Life Sciences, JAN 16, 2025, View Source [SID1234649762]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Rooted in a commitment to rigorous science and cancer care, the collaboration between Caris and Ontada includes strategic pillars spanning the development and delivery of multimodal data solutions, innovative research strategies and data-driven practices to provide actionable cancer care intelligence," said Caris President David Spetzler, MS, PhD, MBA. "By seamlessly integrating key entities of research, biopharma and patients, we collectively aim to revolutionize cancer research, drive innovation, advance precision medicine and improve patient outcomes."

"By bringing together two of the most extensive clinical and genomic data sets in community oncology, we have developed a unique resource for life sciences companies. Our goal with this resource is to empower them to address complex questions, potentially leading to groundbreaking research and improved cancer care," said Christine Davis, Ontada President. "Given the rapid evolution of oncology, this collaboration enables us to deliver insights more quickly, conduct more robust research and continue advancing precision care."

The collaboration leverages Caris’ molecular-rich, multimodal database generated from over 6.5 million tests producing over 13 quadrillion datapoints, and Ontada’s industry-leading real-world oncology data representing over 2.4 million cancer patient records available for research across more than 80 tumor types derived largely from community settings where, according to the National Cancer Institute, an estimated 85% of cancer patients are treated. Bringing together a synergistic convergence of cancer care, diagnostics and drug development, the collaboration extends beyond a combined data solution to advance oncology treatment through joint research projects.

"Caris and Ontada will collaboratively work to bridge the gap between research and real-world application, creating a streamlined pathway from research and development to clinical practice to benefit patients with faster access to more informed treatment decisions, personalized therapies, clinical trials and improved outcomes," said Chairman of the Caris Precision Oncology Alliance, James Hamrick, MD, MPH. "This collaboration marks a transformative approach to cancer care, fostering innovation, efficiency and patient-centered outcomes in oncology."

On January 16, 2025 Prelude Corporation (PreludeDx), a leader in precision diagnostics for early-stage breast cancer, reported that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device designation for its DCISionRT test (Press release, PreludeDx, JAN 16, 2025, View Source [SID1234649763]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DCISionRT provides individualized risk assessment and predicts the benefit of radiation therapy (RT) for women diagnosed with ductal carcinoma in situ (DCIS), also known as Stage 0 breast cancer. DCISionRT represents a significant advancement in DCIS patient care by combining tumor biology with clinicopathologic factors to deliver personalized results. The test analyzes seven protein biomarkers and four clinical factors to generate a Decision Score that helps physicians identify which patients are most likely to benefit from RT and can help reduce over- and under-treatment.

"DCISionRT addresses an unmet need for DCIS patients by answering the questions, ‘Do I need radiation therapy?’, and ‘will I benefit?’. DCISionRT helps patients and their physicians to make a better and more informed treatment decision." says Dan Forche, President and CEO of PreludeDx.

The test is designed for women aged 30-85 with DCIS and:

Predicts the benefit of radiation therapy after breast conserving surgery (BCS)
Is Prognostic for 10-year risk of breast cancer recurrence
Identifies patients with residual risk even after BCS and radiation therapy
The FDA’s Breakthrough Device designation is reserved for medical devices that provide for more effective treatment or diagnosis, and offer significant advantages over existing approved or cleared alternatives. Breakthrough Devices will receive priority review by the FDA, which can significantly shorten the time it takes to get approval.

Forche continued, "We will continue to work closely with the FDA and we remain committed to providing access to advanced precision diagnostics in breast cancer care that improve patient outcomes through new and innovative tools."

About DCISionRT for Breast DCIS

DCISionRT is the only risk assessment test for patients with ductal carcinoma in situ (DCIS) that predicts radiation therapy benefit. Patients with DCIS have cancerous cells lining the milk ducts of the breast, but they have not spread into surrounding breast tissue. In the US, over 60,000 women are newly diagnosed with DCIS each year. DCISionRT, developed by PreludeDx on technology licensed from the University of California San Francisco, and built on research that began with funding from the National Cancer Institute, enables physicians to better understand the biology of DCIS. The test provides a DecisionScore that identifies a woman’s risk as low, elevated, or residual risk. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors, and uses a non-linear algorithm to account for multiple interactions between individual factors in order to better interpret complex biological information. DCISionRT’s intelligent reporting provides a woman’s recurrence risk after breast conserving surgery alone and with the addition of radiation therapy. In turn, this new information may help patients and their physicians to make more informed treatment decisions.