According to the Insight database statistics, this week (January 19 - January 25), a total of 73 innovative drugs (including improved new drugs) worldwide have advanced to a new stage of development, with 1 approved for marketing and 5...Declare listing, 20 products launch clinical trials, 714 products approved for clinical trials, 14 products submitted for clinical trials.Below, Insight will continue to introduce the progress of some key projects at home and abroad this week.Progress of Innovative Drugs OverseasOverseas, this week saw 24 drugs advance in their development phases, including 1 approval for marketing, 8 initiating Phase I clinical trials for the first time, and 6 receiving clinical trial approval for the first time.According to the Insight database, there are 6 new drugs/new indications in four major countries/regions this week.(Mainland China, USA, EMA, Japan)Approved, including 3 from EMA and 3 from FDA. Details are as follows:New Drugs/New Indications Approved This Week (1-19~1-25)
Screenshot from: Insight Database Web Version1. Johnson & Johnson: First Nasal Spray for Treatment-Resistant Depression ApprovedOn January 21, Johnson & Johnson announced that the U.S. FDA had approved SPRAVATO®.(esketamine, Esketamine)New Indication Marketing Application for CIII Nasal Spray（sNDA）, making it the first and only monotherapy for adult patients who have had an inadequate response to at least two oral antidepressants.
Screenshot from: Johnson & Johnson official websiteThe approval was granted after a priority review by the U.S. FDA, based on positive results from a randomized, double-blind, multicenter, placebo-controlled study, in which SPRAVATO® alone showed rapid and significant improvement compared to placebo on the Montgomery-Asberg Depression Rating Scale.（MADRS）Total Score. In the post-hoc analysis, SPRAVATO® showed numerical improvement in all 10 MADRS items at Day 28. At Week 4, 7.6% of patients on placebo achieved remission.(MADRS total score ≤ 12), while 22.5% of patients taking SPRAVATO® achieved remission.As a standalone treatment, the safety profile of SPRAVATO® is consistent with existing clinical and real-world data, and no new safety concerns were identified when used in conjunction with oral antidepressants.Esketamine is an NMDA receptor antagonist that works by targeting glutamate, the most abundant excitatory neurotransmitter in the brain. Johnson & Johnson reformulated this active ingredient into a nasal spray, which was first approved for marketing in the United States on March 5, 2019.Used in combination with oral antidepressants to treat adult patients with severe depression who are resistant to existing therapies, becomingThe first antidepressant with a new mechanism of action approved by the FDA in nearly 30 years.In 2020, the drug was approved again for a new indication, targeting depression accompanied by acute suicidal thoughts or behaviors.（MDD）Adult patients, and is also the first FDA-approved drug to significantly reduce depressive symptoms within 24 hours.On April 17, 2023, the drug was also approved for marketing in China.The newly approved indication this time is for monotherapy. According to the Insight database, this sNDA began its marketing application process in the United States in July 2024.
2. Johnson & Johnson: EGFR/c-MET Bispecific Antibody Combination Therapy Approved for Marketing in the EU, First-Line Treatment for NSCLCOn January 21, Johnson & Johnson announced that the European Commission（EC）LAZCLUZE® has been approved.(lazertinib, Lazertinib)Combined use of RYBREVANT®(amivantamab, Rybrevant)Marketing Application（MA），First-line treatment for adult patients with advanced NSCLC harboring EGFR exon 19 deletions or L858R substitution mutations.
Screenshot from: Johnson & Johnson official websiteThis EU approval is based on the Phase 3 clinical trial MARIPOSA study.（NCT04487080）。MARIPOSA Study is a randomized Phase 3 clinical trial, enrolling a total of 1074 patients, aimed at evaluating the first-line treatment of EGFR/c-MET bispecific antibody Amivantamab in combination with third-generation EGFR-TKI Lazertinib for EGFR-mutant NSCLC.The study met the primary endpoint of progression-free survival.（PFS）. These data were presented at the Presidential Symposium of the 2023 ESMO Congress, while longer-term follow-up data were showcased at the 2024 International Association for the Study of Lung Cancer.（IASLC）World Lung Cancer Conference（WCLC）Published on.
On January 7, 2025, Johnson & Johnson announced positive new overall survival data.（OS）Topline results indicate that amivantamab + lazertinib reached the final pre-specified secondary endpoint of OS, and demonstrated a clinically meaningful and statistically significant improvement in OS compared to the current standard of care, osimertinib monotherapy. The median OS is expected to exceed one year. These landmark OS data will be presented at an upcoming medical conference.
Heavyweight Clinical Results1. New Opioid Analgesic! First Oral Dual NMR Agonist Successful in Phase III Clinical TrialOn January 22, Tris Pharma announced its treatment forAcute PainTheFirst Oral Dual NMR AgonistCebranopadol's Pivotal Phase III Clinical Trial ALLEVIATE-1 Achieves Positive Results.
Screenshot source: Corporate official website
ALLEVIATE-1 Clinical Trial (NCT06545097) A multicenter, randomized, double-blind, placebo-controlled Phase III study. The study aims to evaluate the efficacy and safety of Cebranopadol compared with placebo for moderate to severe acute pain following full abdominoplasty. The primary endpoint is based on the Numerical Rating Scale.（NRS）Evaluation of the analgesic effect.
Clinical study results show that, compared with placebo,Use 400 µg(Once daily for two consecutive days)Cebranopadol Treatment Significantly Reduces Pain Intensity(The least squares mean difference is 59.2)In addition, Cebranopadol is generally well-tolerated, with a safety profile comparable to placebo, and no serious adverse events related to Cebranopadol have been reported. The most common adverse event is nausea.
Cebranopadol is an FIC experimental therapy that targets both NOP and MOP receptors.(Dual NMR Agonist), for the treatment of moderate to severe pain and opioid use disorder (OUD). These two receptors are partially homologous and play complementary and distinct roles in modulating the biological signaling pathways of pain.
Currently, more than 2,200 patients have participated in the pain management studies for Cebranopadol. Studies have confirmed that Cebranopadol demonstrates positive clinical outcomes in acute pain, chronic pain, and diabetic neuropathic pain, with a favorable safety profile. The FDA has also granted CebranopadolFast Track Designation, used to treat chronic low back pain.
Tris Pharma's press release pointed out that, if approved, the drug will becomeThe First Dual NMR Pain Relief Therapy，With efficacy comparable to that of opioids，But the risk of abuse or physical dependence, addiction, or overdose is lower.2. Novo Nordisk: Announced Phase 1b/2a Clinical Results of New Weight Loss Drug, 20% Weight Loss in 36 WeeksOn January 24, Novo Nordisk announced the topline results of the Phase 1b/2a trial for Amycretin, a GLP-1/amylin dual receptor agonist. This is a once-weekly subcutaneous injection therapy for weight loss.
Screenshot source: Company official website
The study investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of weekly subcutaneous injections of Amycretin in 125 overweight or obese individuals.The primary endpoint was treatment-emergent adverse events. The results showed,Amycretin The safety profile is consistent with incretin-based therapies. UseAmycretin The most common adverse events were gastrointestinal, and the vast majority were mild to moderate.
In terms of efficacy, from an average baseline weight of 92.7kgStart, 1.25mg dose group patients(20 weeks)Weight loss of approximately 9.7%,Patients in the 5mg dose group(28 weeks)Weight loss of approximately 16.2%,Patients in the 20mg dose group(36 Weeks)Weight loss was approximately 22.0%, while the placebo group experienced weight increases of 1.9%, 2.3%, and 2.0%, respectively.
3. Antengene: CLDN18.2 ADC Announces Positive Phase II Clinical ResultsOn January 22, Antengene announced the presentation of ongoing Phase I/II clinical evaluation of ATG-022 in China and Australia at ASCOGI 2025.(CLDN18.2 ADC) Latest Data from the CLINCH Study on Treating Patients with Advanced or Metastatic Gastric Cancer.
Screenshot source: Official WeChat account of the company
CLINCH Study is an ongoing Phase I/II clinical trial being conducted in China and Australia, comprising two stages: dose escalation and dose expansion. As of November 22, 2024, 21 gastric cancer patients with CLDN18.2 expression IHC 2+ >20% in the dose expansion phase have received at least one tumor assessment, with an overall response rate. (ORR) At 42.9%, the disease control rate(DCR) For 95.2% (9 cases achieved partial remission)[PR], including 8 confirmed PR cases and 11 cases achieving stable disease.[SD] ) 。10 patients with CLDN 18.2 expression IHC 2+<20% gastric tumors received an effective dose of 1.8-2.4mg/kg.Therapy, ORR was 30.0% (1 case achieved complete remission).[CR], 2 cases achieved PR, all PR/CR were confirmed and had CLDN 18.2 expression IHC 2+ (<5%), with a DCR of 50.0%. The patient who achieved CR demonstrated durable response and had been participating in the study for over 14 months as of the data cutoff date.
ATG-022 in various CLDN18.2 expression levels in advancedIn patients with advanced gastric cancer,可控的安全性和良好The preliminary efficacy, these data support in gastric cancer patientsFurther clinical evaluation of ATG-022 is underway. The current study focuses on dose optimization in gastric cancer patients.The enrollment of its solid tumor cohort is currently ongoing in China and Australia.In progress.
Heavyweight Pharmaceutical DealsAccording to the Insight database, a total of 9 transaction events occurred this week (January 19 - 25).1. AbbVie: Over $1.6 Billion Heavy Bet on Molecular Glue Degraders
On January 24, AbbVie and Neomorph announced a collaboration and license option agreement to jointly developNovel Molecular Glue Degraders Targeting Multiple Oncology and Immunology TargetsAccording to the terms of the agreement, Neomorph will receive an upfront payment from AbbVie and is eligible to receive up to$1.64 billionThe total amount of option fees and milestone fees, as well as tiered royalties on net sales.
Screenshot source: Corporate official website
Molecular glue degraders are a new class of small molecules designed to selectively target and trigger the degradation of proteins that cause cancer growth or immune system dysfunction, offering more precise treatment options. Molecular glue degraders have the potentialTargeting proteins historically defined as "undruggable."2. InnoCare Pharma/Connaught Medical: $520 Million! CD20 x CD3 Bispecific Antibody Achieves Overseas LicensingOn January 20, InnoCare Pharma and Connaught Biologics jointly announced that both companies, along with their joint venture, collectively partnered with Prolium Bioscience.(hereinafter referred to as Prolium)Reach a licensing cooperation,Authorization for Prolium to Develop and Commercialize CD20×CD3 Bispecific Antibody ICP-B02 (CM355)。InnoCare and Connaught will receive up to$520 millionThe total payment, including the down payment and recent payments, etc.
Screenshot source: InnoCare Pharma announcementICP-B02 is a bispecific antibody jointly developed by InnoCare Pharma and Connaught Biologics. It can specifically bind to CD20-positive target cells and CD3-positive T cells, recruiting immune T cells to the vicinity of target cells, activating T cells, and inducing T cell-mediated tumor cell killing.（TDCC）Target cell killing effect, with potential therapeutic value in both tumor and non-tumor fields.ICP-B02 is currently conducting Phase I/II clinical trials in China.Aimed to evaluate ICP-B02 in relapsed/refractory non-Hodgkin lymphoma（NHL）PatientSafety, Tolerability, Pharmacokinetics（PK）And anti-tumor activity.According to the terms of the agreement,Prolium will obtain the rights to develop, register, manufacture, and commercialize ICP-B02 in non-oncology fields globally and in oncology fields outside of Asia.。InnoCare and ConnaMed will receive total payments of up to 520 million US dollars, including upfront and near-term payments., as well as additional payments for achieving clinical development, registration, and commercialization milestones. Both parties will also receive a minority stake in Prolium.At the same time, InnoCare Pharma and Connaught Medical will receive tiered royalties on future net product sales.3. QuidMed: Over 13 billion USD! FGFR3 ADC and Innovative Conjugation Technology Platform Make a Significant Overseas DebutOn January 24, according to Suzhou Daily News,Qid TherapeuticsThe parent company Qiguang Dejian has partnered withU.S. Biohaven, South Korea AimedBioSignificant contract reached, cooperation content includesBiohaven Obtains Exclusive Global Development and Commercialization Rights for First-in-Class FGFR3 ADC Drug GQ1011, andInnovation Biocoupling Core Platform Technology License Granted to Two Companies, Empowering Partners in the United States and South KoreaADC drugs targeting a total of 21 targetsInnovation.The total amount exceeds 13 billion US dollars.
GQ1011 is a product jointly developed by Qide Medicine and AimedBio.First-in-class ADC targeting FGFR3. This product uses AimedBio's FGFR3 antibody with a differentiated advantage as the targeting molecule, combined with a novel topoisomerase Topolx independently developed by Qide Medicine as the payload. It is developed through intelligent continuous conjugation technology and stable linker technology, and is expected to become the world's first FGFR3-targeted ADC drug.Previously, in April 2023, Etern Therapeutics GQ1010（TROP2 ADC ）Global development and commercialization rights outside of Greater China haveAt a price exceeding $1.02 billionExclusively licensed to U.S.-based Pyramid Biosciences(The company was acquired by Biohaven in January 2024.). This time it is QuidMed.The 2nd Major Overseas Deal。
4. LePu Bio: Over $1.2 Billion! Preclinical ADC Major Overseas DealOn January 22, Lepu Biopharma announced a collaboration with ArriVent BioPharma, Inc. regardingMRG007: A Potential Best-in-Class Antibody-Drug Conjugate for Gastrointestinal CancerReach a global exclusive license agreement.According to the agreement, Leap Therapeutics granted ArriVent in Greater China(Including mainland China, Hong Kong, Macao, and Taiwan)Global exclusive license for the development, manufacturing, and commercialization of MRG007 outside of China. In return, LePu Bio will receive a total of$47 millionA one-time upfront payment and near-term milestone payments, and up to$1.16 billionMilestone payments for development, registration, and sales, as well as tiered royalties based on net sales in regions outside of Greater China.Screenshot source:Corporate Official Weibo
MRG007 Demonstrates Potent Antitumor Activity in Preclinical Models of Gastrointestinal Cancer and Shows a High Therapeutic Index in IND-Enabling Studies.The press release from Lepu Biopharma stated that the first IND application is planned to be submitted in the first half of 2025, with the initial clinical development focus onColorectal cancer, pancreatic cancer, and other gastrointestinal malignancies。
Progress of Innovative Drugs in ChinaThis week, a total of 55 innovative drugs (including improved new drugs) in China have advanced to a new stage of development, with 7 filing for marketing approval, 4 initiating Phase III clinical trials, 8 receiving clinical approval, and 17 filing for clinical trials.15 Innovative Drugs (Including Modified New Ones) Launched in Clinical Trials for the First Time in China This Week
Source: Insight Database Web Version(The following text is from the same source unless otherwise specified.)1. Sanofi: CD38 Monoclonal Antibody New Indication Approved for Marketing in ChinaJanuary 24,SanofiAnnounce itsCD38 Monoclonal Antibody "Isatuximab"New indications approved for marketing in China,Used forIn combination with bortezomib, lenalidomide, and dexamethasone (VRd), for the treatment of newly diagnosed multiple myeloma (NDMM) patients who are not eligible for autologous stem cell transplantation (ASCT).Adult patients.
Screenshot source: Official WeChat account of the companyThe press release pointed out,IsatuximabYesThe World's FirstFDA Approval ObtainedApproved for use in combination with standard treatment VRd for patients ineligible for ASCTThe anti-CD38 monoclonal antibody for NDMM patients has now also becomeChinaChina's FirstAnd currently the only approved anti-CD38 monoclonal antibody for this indicationAnti.Isatuximab（Isatuximab）Is a monoclonal antibody drug that Sanofi introduced from ImmunoGen. The collaboration between the two parties was reached as early as 2017. In March 2020, the drugFirst FDA Approval for U.S. Market, in combination with pomalidomide and dexamethasone（pom-dex）Combination therapy for patients who have received at least two prior treatments(Including lenalidomide and proteasome inhibitors)Relapsed and Refractory Multiple Myeloma（R/R MM）Adult patients, brand nameSarclisa®；In May and June of the same year, it was approved in the European Union and Japan, respectively.January 2025,IsatuximabFirst Approval for Marketing in China。At the 2024 ASCO Conference, Sanofi announced a randomized, open-label, multi-centerIMROZ Phase III Clinical StudyThe results. This study aims to compare the clinical benefits of the following two medication approaches for newly diagnosed multiple myeloma patients who are not eligible for transplantation: one isIsatuximabIn combination with bortezomib, lenalidomide, and dexamethasone（VRd）, and the other is bortezomib, lenalidomide, and dexamethasone（VRd）. The primary endpoint of the study is progression-free survival.(PFS)。As of September 26, 2023, compared toVRd group, isatuximab combined withVRd GroupMedian PFS Not Reached(vs 54.3 months)，CanSignificantly Reduce 40% risk of recurrence or death.This makes the drugThe FirstCD38 Monoclonal Antibody Significantly Improves PFS When Combined with VRd in Phase III Clinical Trials for Newly Diagnosed MM Unsuitable for Transplant.The research results have been simultaneously published in The New England Journal of Medicine.
2. Kelun Biotech: New Indication for PD-L1 Monoclonal Antibody Approved,First-line Treatment for Nasopharyngeal CarcinomaOn January 20, the official website of the National Medical Products Administration (NMPA) showed that Kelun Botai's Tagralimab Injection received approval for a new indication, to be used in combination with gemcitabine and cisplatin.First-line treatment for recurrent or metastatic nasopharyngeal carcinoma。(Application No.: CXSS2400049)
As of the end of December 2024, Tagoletimab has been approved by the drug regulatory authority for the treatment of recurrent or metastatic (R/M) nasopharyngeal carcinoma that has failed previous second-line or higher chemotherapy.This approval,Further Expansion of the Target Population for Tagozumab in Nasopharyngeal Carcinoma。
Source:Screenshot of the NMPA official websiteTagolimumab is a humanized IgG1κ subtype monoclonal antibody that specifically binds to PD-L1, blocking its interaction with PD-1, thereby relieving the inhibition of T cells by tumor cells through the PD-1/PD-L1 pathway and restoring the anti-tumor immune response of immune cells.In August 2018, Kelun-Biotech exclusively licensed the development, manufacturing, and commercialization rights of Tagolimab outside of Greater China to Harbour BioMed.
Currently, Tagoletimab is undergoing a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial for first-line treatment of R/M NPC in combination with cisplatin and gemcitabine versus placebo combined with chemotherapy.（CTR20220691）, enrolling a total of 295 subjects.
Kelon Biotech once stated in its earnings report that Tagrilimab is not only used as a monotherapy, but more importantly, in combination with ADC and other oncology assets. According to the Insight database, Kelon Biotech is currently conducting Phase II clinical trials of Tagrilimab in combination with Lukansatuzumab for the treatment of non-small cell lung cancer and breast cancer.
3. Zhi Xiang Jin Tai: IL-17A Monoclonal Antibody New Indication Approved for Marketing, Treating Ankylosing SpondylitisOn January 20, the NMPA website showed that Zhi Xiang Jin Tai's Class 1 new drug, Selicrelumab(GR1501 Injection)New indications approved for marketing in China, used for treatmentRadiographic Axial Spondyloarthritis (Ankylosing Spondylitis)。
Screenshot source: NMPA official websiteCeralikimab is a self-developed IL-17A monoclonal antibody by Zhixiang Jintai. It can specifically bind to the IL-17A protein in serum through antibodies, block the binding of IL-17A to IL-17RA, and inhibit the occurrence and development of inflammation.August 2024, SelicizumabFirst approved for marketing in China, for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.It is worth mentioning that new indications are still under development for secukinumab, among whichLupus NephritisHas entered Phase II clinical trials,Psoriatic ArthritisAlso in the process of applying for clinical trials.Insight database shows that there are 26 IL-17A single-target new drugs under research globally.(Only active status is counted), of which 4 have been approved for marketing, with only 2 produced in China, respectively.HengruiFenacizumab andZhi XiangJin Tai Sai Li Qi Monoclonal Antibody. Other domestically produced new drugs under research include 1 at the marketing application stage, from3SBioIn addition, four more products have entered Phase III clinical trials.1、Hengrui: China's First Long-Acting Insulin Submitted for Market Approval
On January 23, Hengrui announced the submission of its Class 1 therapeutic biological product.Insulin Glargine InjectionThe application for marketing authorization of the drug has been accepted by the National Medical Products Administration (NMPA).For the treatment of adult type 2 diabetes。The product isIn ChinaThe First Self-Developed Long-Acting Insulin Analog。
Source: Corporate AnnouncementSudylinsulin Injection is a basal long-acting insulin independently developed by Hengrui.Smooth onset, long duration of efficacy, and low risk of nocturnal hypoglycemiaSuch advantages. Currently, similar products have been approved for marketing worldwide, such as Novo Nordisk's insulin degludec.（Tresiba）and Sanofi's insulin glargine（Toujeo）Insight database shows that the sales of Tresiba and Toujeo in 2023 were $1.126 billion and $1.215 billion, respectively.In December 2024, Sube insulin injection for the treatment of adult type 2 diabetes（T2DM）Patient'sTwo Key Phase III Clinical Trials(Study 301 and Study 302)All completedThese are multicenter, randomized, open-label, positive drug parallel-controlled Phase III studies evaluating the efficacy and safety of Suliqu insulin injection and Insulin Glargine in T2DM patients with poor glycemic control on basal insulin therapy and those with poor glycemic control on oral antidiabetic drugs.Study 301 was led by Zhongshan Hospital Affiliated to Fudan University, with participation from 56 centers across China, and a total of 423 subjects were randomly enrolled. Study 302 was led by Peking University People's Hospital, with participation from 68 centers across China, and a total of 513 subjects were randomly enrolled.The results of both studies indicate that,After 26 weeks of treatment with Suliqua insulin, with or without oral hypoglycemic agents, the change in glycated hemoglobin (HbA1c) from baseline was non-inferior to that of insulin glargine.In T2DM patients, the safety and tolerability of insulin glargine U300 were good. The nature of adverse events was similar to that of insulin glargine U100, with slightly fewer hypoglycemic events and nocturnal hypoglycemic events compared to the insulin glargine U100 group. Both studies met their primary endpoints.To date, the total R&D expenses invested in the projects related to insulin glargine injection have amounted to approximately 348.8 million yuan.
2、Teva: New Migraine Drug Submitted for Marketing Approval in China, Administered Once Every 3 Months
On January 22, the CDE website showed that Teva PharmaceuticalsRemanezumab Injection Marketing Application Accepted. Based on the progress of clinical trials, the Insight database speculates that it is used forPreventive Treatment for Migraine。
Source: CDE Official WebsiteRimegepant is a humanized monoclonal antibody that selectively binds to calcitonin gene-related peptide.（CGRP）Ligand, and blocks both CGRP subtypes(α- and β-CGRP)Binding to receptors, can be used forAdult patients with at least 4 migraine days per month for the preventive treatment of migraine, which can significantly reduce the frequency of migraine attacks.。Remanezumab is currently the only one withOnce a quarter（675mg）AndOnce a month（225mg）CGRP monoclonal antibodies with flexible subcutaneous injection options. The drugApproved in the United States, the European Union, Japan, and other countries and regionsFor the preventive treatment of migraine in adult patients, and successfully landed in the Guangdong-Hong Kong-Macao Greater Bay Area in October 2023 through the "Hong Kong-Macao Medicine and Device Connect" policy.In April 2024, Teva announcedResults of the Chinese Phase III Study on Remanezumab for Preventive Treatment of Migraine. This is a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy of subcutaneous administration of Remanezumab in patients with episodic or chronic migraine.(Age 18-70 years)Effectiveness, safety, and tolerability.A total of 365 patients were recruited for the study and randomly assigned in a 1:1:2 ratio to receive subcutaneous injections of Remanezumab monthly, quarterly, or placebo.The primary objective is to demonstrate the efficacy of Remanezumab in Chinese adult subjects suffering from migraines.. The secondary objective is to further demonstrate the efficacy, safety, and tolerability of Remanezumab.Results showed that Remanezumab successfully achieved the primary endpoint and all secondary endpoints, with a significant reduction in monthly migraine days, demonstrating efficacy superior to placebo.At 12 weeks of treatment, the Remanezumab treatment group showed a greater average reduction in monthly migraine days from baseline compared to placebo.(-4.6 days vs -2.8 days, P<0.0001), and a reduction in migraine days was observed as early as the first week of treatment.
1、Head-to-Head K Drug! Innovent Initiates Phase II Clinical Trial of PD-1/IL-2 for MelanomaJanuary 22,The official website of the Drug Clinical Trial Registration and Information Disclosure Platform shows that Innovent Biologics has registered a head-to-head trial evaluating IBI363 monotherapy versus pembrolizumab.(K Medicine)Phase II Clinical Trial for the Treatment of Advanced Melanoma Patients（CTR20250280）。
Source:Official Website of Drug Clinical Trial Registration and Information Disclosure PlatformThis is a randomized, open-label, multi-center Phase II study aimed at evaluating IBI363 monotherapy compared to pembrolizumab in patients with unresectable locally advanced or metastatic disease who have not previously received systemic treatment.Mucosal and Acral MelanomaEfficacy and safety in subjects,Plan to enroll 180 subjects。The primary endpoint isAs reviewed by the Independent Imaging Review Committee（IRRC）According to the Response Evaluation Criteria in Solid Tumors（RECIST）V1.1 Evaluation of Progression-Free Survival（PFS）. Secondary endpoints include PFS assessed by investigators, IRRC, and objective response rate evaluated by investigators.（ORR), Duration of Relief（DoR）、Disease Control Rate（DCR）, Time to Alleviation（TTR）, Overall Survival（OS）etc.
IBI363 is a self-developed product by Innovent Biologics.World's First PD-1/IL-2 Bispecific Fusion Protein, while simultaneously possessing two functions: blocking the PD-1/PD-L1 pathway and activating the IL-2 pathway. The IL-2 arm of IBI363 has been specifically engineered to retain its affinity for IL-2 Rα but reduce its binding ability to IL-2Rβ and IL-2Rγ, thereby decreasing toxicity; meanwhile, the PD-1 binding arm can both block PD-1 and selectively deliver IL-2.2、GSK: BCMA ADC Initiates Head-to-Head Daratumumab Phase III Clinical Trial for First-Line Treatment of Multiple MyelomaOn January 22, GSK registered a clinical trial on the Drug Clinical Trial Registration and Information Disclosure Platform.Belantamab mafodotin(Marvelant Monoclonal Antibody)In combination with lenalidomide and dexamethasone（BRd）Head-to-Head Daratumumab in Combination with Lenalidomide and Dexamethasone（DRd）First-line Treatment for Multiple MyelomaThe Phase III DREAMM-10 Study.
Source:Official Website of Drug Clinical Trial Registration and Information Disclosure PlatformDREAMM-10 is a randomized, parallel-group, open-label international multicenter Phase III clinical trial designed to evaluate BRd versus DRd inNewly Diagnosed Multiple Myeloma Unsuitable for Autologous Stem Cell Transplant（ TI-NDMM ）The efficacy and safety in subjects. A total of 165 institutions globally are participating, with plans to enroll 80 subjects in China and 520 subjects internationally. The primary endpoint is progression-free survival.（PFS）、MRD-negative status.Belantamab mafodotin is aAntibody-Drug Conjugates (ADC) Targeting BCMAIn August 2020, based on the results of the pivotal Phase II clinical DREAMM-2 study, the drug received accelerated FDA approval and conditional EMA approval for marketing as a monotherapy for adult patients with relapsed/refractory multiple myeloma, becoming the world's first approved BCMA ADC.However, due to the Phase III DREAMM-3 study not meeting its primary endpoint of PFS, GSK voluntarily withdrew the U.S. marketing application for Belantamab mafodotin in November 2022. In April 2024, the EU also withdrew the marketing authorization for Belantamab mafodotin.Although the initial market launch was not smooth, research shows that Belantamab mafodotin can still benefit some patients with multiple myeloma. In November 2024, GSK announcedBelantamab Mafodotin in Combination with Bortezomib and Dexamethasone（BorDex）Positive Interim Results from Phase III DREAMM-7 Study of Head-to-Head Comparison of Daratumumab in Combination with BorDex for Second-Line Treatment of Relapsed or Refractory Multiple Myeloma, reaching the overall survival period（OS）The key secondary endpoint.GSK has successively submitted the marketing application for Belantamab mafodotin as a second-line treatment for multiple myeloma to regulatory agencies such as NMPA, FDA, and EMA.3、Takeda: Weekly CD38 Monoclonal Antibody Enters Phase III Clinical Trial in ChinaOn January 21, the Drug Clinical Trial Registry and Information Disclosure Platform showed that Takeda registered aMezagitamab（TAK 079）Subcutaneous InjectionTreatment of Chronic Primary Immune Thrombocytopenia（ITP）Phase III Clinical Trial。
Source:Drug Clinical Trial Registry and Information Disclosure Platform
This is a randomized, double-blind, parallel-group, placebo-controlled international multicenter Phase III clinical study aimed at evaluating the efficacy and safety of Mezagitamab compared to placebo in achieving durable platelet responses in subjects with chronic ITP aged ≥18 years.
The primary endpoint was a durable platelet response achieved at Week 24., secondary endpoints include the cumulative number of weeks with platelet counts ≥50,000/μL up to Week 24, time to first achievement of platelet count ≥50,000/μL, cumulative number of weeks with platelet counts ≥30,000/μL and at least doubling from baseline up to Week 24, achievement of complete platelet response, etc.
The study involved a total of 104 institutions, including 16 from China, with the principal investigator being Dr. Renchi Yang, Chief Physician at the Institute of Hematology, Chinese Academy of Medical Sciences.ResearchIt is expected to screen 50 subjects in China and enroll 30 subjects.。The international plan enrolled 117 subjects.
The press release shows that Mezagitamab is a fully human immunoglobulin IgG1 monoclonal antibody.（mAb）, for cells expressing CD38(including plasmablasts, plasma cells, and natural killer cells)With high affinity, leading to the exhaustion of these cells. Mezagitamab can provide rapid and sustained improvement in platelet response and restore platelet counts to functional levels.The product is injected subcutaneously once a week.
4、AstraZeneca: PD-1/CTLA4 Bispecific Antibody Enters Phase III Clinical TrialJanuary 24,The official website of the Drug Clinical Trial Registration and Information Disclosure Platform shows that AstraZeneca has registeredA Volrustomig(Vosumab, PD-1/CTLA4 Bispecific Antibody）TreatmentHigh-Risk Locally Advanced Cervical CancerGlobal Phase III Study in Women（CTR20250226）。
Screenshot source: Drug Clinical Trial Registration and Information Disclosure Platform
This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study of Volrustomig in women with high-risk locally advanced cervical cancer who have not progressed after platinum-based concurrent chemoradiotherapy.（eVOLVE-Cervical），Primary EndpointIs PFS。The trial involved a total of 213 institutions, with plans to enroll 130 subjects in China and 800 subjects internationally.Volrustomig is a PD-1/CTLA4 bispecific antibody. Apart from cervical cancer,AstraZeneca TargetsVolrustomigand has laid out multiple indications,Non-Small Cell Lung Cancer、Pleural MesotheliomaAndSquamous Cell Carcinoma of the Head and NeckHave all entered Phase III clinical trials,Biliary Tract Cancer, Liver Cancer, Stomach CancerHas also entered Phase II clinical trials.Insight database shows that there are 7 bispecific antibody new drugs with the same target under research globally, and onlyKangfangCadonilimab 1 approved for marketing. In addition, there are 5 in the clinical stage, includingVolrustOMIG isThe fastest progressofPD-1/CTLA4 Bispecific Antibody.Source:Official News/Information Released by Pharmaceutical Companies, Insight DatabaseCover Source:ZCOOL Hello Plus
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