In the pharmaceutical field, an environment of "If one renews oneself daily, one will achieve constant innovation and progress," innovation and breakthroughs are eternal themes.2024Year1Month5Day,FDAApprovalZelsuvmi™（BerdazimerTopical Gel,10.3%), for the treatment of infectious molluscum in adults and children aged one year and above, becoming the first novel drug globally for the treatment of molluscum contagiosum infection, as well as the first topical prescription medication for this highly contagious viral skin infection.So, which drugs are expected to be approved by the FDA in 2024?Note: The Prescription Drug User Fee Act (PDUFA), which began in 1992PDUFA), known in the industry as "the cornerstone of modern U.S. new drug review," ushering in a new era of new drug review and approval, and still being updated and used to this day.
Original PDUFA Date: 2024.01.12
ZolbetuximabIt was developed by a German biotechnology company.GanymedA targetedCLDN18.2Human ProteinIgG1Chimeric mouse monoclonal antibody drugs with constant regions.2016Year10In the month, Astellas14Billion-dollar acquisitionGanymed, willZolbetuximabSecured.CLDN18.2 is overexpressed in many cancers, especially gastric cancer.The positive rate of HER2 in gastric cancer patients is less than 20%, while the positive rate of CLDN18.2 in related cancers exceeds 50%, making it a popular target in the field of gastric cancer.。CurrentlyNo CLDN18.2-targeted drug has been approved for marketing yet.Previously, Zolbetuximab had been the frontrunner among CLDN18.2-targeted drugs. In July 2023, Astellas submitted a New Drug Application (NDA) for Zolbetuximab to the FDA and was granted Priority Review status, with a Prescription Drug User Fee Act (PDUFA) date set for January 12, 2024.However, on January 9, 2024, Astellas announced a Complete Response Letter issued by the FDA on January 4:FDA States It Cannot Approve BLA Before PDUFA Action Date of January 12, 2024, Due to Unresolved Deficiencies at Third-Party Manufacturing Facility[1]。This black swan event caused delays.zolbetuximabBecame the first targeted drug to be launchedCLDN18.2 Gastric cancer drugs, reducing the time of market exclusivity.After all, except forzolbetuximab，There are still many under research in clinical practice.CLDN18.2Targeted drugs, such as those from Transcenta Holdingosemitamaband OtsukaASKB589etc.However, the good news isThe FDA has not raised any concerns about the clinical data of zolbetuximab (including efficacy or safety) and has not requested additional clinical studies.MoreoverAstellas is working closely with the FDA and third-party manufacturers to develop a timeline to quickly address the agency's feedback.Zolbetuximab still holds great promise this year.FDA Approved for Marketing.The marketing application of Zolbetuximab in China was accepted on August 1, 2023, for the treatment of gastric cancer and gastroesophageal junction (GEJ) adenocarcinoma, becoming the first CLDN18.2 monoclonal antibody to be submitted for marketing approval in China.
Lifileucel
PDUFA Date：2024.02.24
Lifileucel, developed by Iovance Biotherapeutics, is a TIL (Tumor Infiltrating Lymphocyte) therapy currently being evaluated in multiple clinical trials as a monotherapy or in combination regimens for the treatment of patients with advanced melanoma who have progressed during or after prior anti-PD-1/L1 therapy and targeted therapy (if applicable) (Figure 1).
Figure 1. Development Progress of Lifileucel
TIL TherapyIt belongs to immunocyte therapy, consisting of a heterogeneous population of cells including CD8+ T cells, CD4+ T cells, B cells, NK cells, and γδ T cells, primarily exerting direct cytotoxic effects on tumor cells through CD8+ T cells.The technical process of TIL cell therapy is toT cells isolated from tumor tissues are stimulated and expanded in vitro, then infused back into the patient's body to enhance the immune response for treating primary or metastatic tumors.。2023Year3Month24Day,IovanceAnnouncementLifileucelHas successfully completed its rolling listing application submission,PDUFADate:2023Year9Month11Day.However, in September 2023, the FDA stated that they did not have sufficient resources to review the recent submissions before the late-cycle review meeting scheduled for September 11, 2023.LifileucelResponse to the Information Request for the Ongoing BLA Review.FDA Extends PDUFA Date to February 24, 2024, but agreed to cooperate with Iovance to expedite the remaining reviews for a potentially earlier approval date. If approved, Lifileucel will become the first and only TIL therapy for patients with advanced melanoma, as well as the first one-time cell therapy for solid tumor cancers [2].Previously, in May 2023, the FDA had granted lifileucel priority review and also designated it as a Regenerative Medicine Advanced Therapy (RMAT) for advanced melanoma. The extension of the PDUFA date will not affect its priority review status or RMAT designation.At the 2023 ESMO Congress, Lifileucel delivered positive clinical outcomes for patients with advanced mucosal melanoma:Assessed by the Independent Review Committee (IRC) using RECIST v1.1ORR is 50%(95% CI: 21%–79%). At a median study follow-up of 35.7 months,Not Reached (NR) Median Duration of Response (DOR), Median Progression-Free Survival (PFS) is NR(95% CI: 1.4 months – NR), with a median overall survival (OS) of 19.4 months (95% CI: 7.9 months – NR). Treatment-emergent adverse events (TEAEs) were consistent with the known safety profiles of lymphodepleting chemotherapy and interleukin-2 (IL-2) [3].
Roluperidone
PDUFA Date：2024.02.26
Roluperidone is developed byMinerva NeurosciencesAcquires Global Development Rights from Mitsubishi PharmaTheA drug that can block serotonin, sigma, and α-adrenergic receptors, Roluperidone is designed to avoid directly blocking dopaminergic receptors (the key pharmacological target of first- and second-generation antipsychotics) while maintaining blockade of the 5-HT2A specific subtype serotonin receptor (another key target of second-generation antipsychotics) as well as other pharmacological targets (sigma2 and adrenergic-α1A).For the treatment of negative symptoms in schizophrenia patients[4]。Schizophrenia is a chronic, severe, and debilitating mental illness characterized by distortions in thinking, perception, emotions, language, self-awareness, and behavior. Schizophrenia affects people worldwide.200010,000 people.Negative symptoms can make schizophrenia patients become uninterested in anything, unable to complete tasks, or feel pleasure. The characteristics of negative symptoms include five structures: blunted affect, alogia, aphasia, anhedonia, and asociality.Negative symptoms are the main cause of functional impairment in patients with schizophrenia., which may also be one of the main reasons why ultra-high-risk adolescents could develop into full-blown schizophrenia.Currently, there is no approved treatment for the negative symptoms of schizophrenia in the United States.。2022Year8Month,MinervaFor the first time toFDASubmitRoluperidoneFor the treatment of negative symptoms in schizophrenia patientsNDA。This NDA submission was supported by results from two late-stage controlled studies in patients with moderate to severe negative symptoms and stable positive symptoms of schizophrenia (Study MIN-101C03 and Study MIN-101C07).[5]。MIN-101C03 The research results show: treatment12 Weeks later,RoluperidoneSuperior to placebo in alleviating the negative symptoms of schizophrenia. In the primary efficacy analysis, according toPANSS Pentagonal Structure Model Negative Score (PSM) Measurement (p ≤ 0.0036），64 mg RoluperidoneResulted in a statistically significant reduction in the negative symptoms of schizophrenia.A post hoc analysis of changes in the PANSS Marder Negative Symptom Factor Score (NSFS) from baseline to Week 12 also showed a statistically significant difference in the 64 mg Roluperidone group compared to placebo.(p ≤ 0.001) (Figure 2).After 12 weeks in the double-blind (DB) period, statistically significant improvements were also observed with 64 mg Roluperidone compared to placebo in multiple secondary/exploratory efficacy analyses. At 24 weeksDuring the Open Label (OL) Period, NSFS has also been further improved. The MIN-101C07 study also demonstrated that Roluperidone is superior to placebo [6].
Figure 2. Treatment Effect of Roluperidone
However2022Year10Month,MinervaIndicates that the company has receivedFDARefuseRoluperidoneOfNDA。FDAExpressed,MinervaCan request to conveneAType of Meeting: Discussion on the Content of the Rejection Submission Letter[7]。On May 10, 2023, Minerva Neurosciences, Inc. updated the NDA status of Roluperidone.FDAReaccepted on May 8, 2023NDA for Roluperidone,FDA Sets PDUFA Goal Date for February 26, 2024[9]. If approved, Roluperidone may represent an important new option to address the significant unmet needs faced by individuals with schizophrenia, whose negative symptoms are a major source of disability and adversely impact their quality of daily life.
Resmetirom
PDUFADate: 2024.03.14
Resmetirom is a once-daily oral medication developed by Madrigal Pharmaceuticals.Thyroid hormone β receptor (THR-β) selective agonist, used for the treatment ofNonalcoholic Steatohepatitis (NASH)。Thyroid hormones activateβReceptors play a central role in liver function, which influences a series of health parameters.Impaired thyroid hormone signaling exacerbates hepatic lipotoxicity, leading toNonalcoholic Fatty Liver Disease (NAFLD)Progress toNASHAnd accompanied by liver fibrosis. In human NASH, the liver exhibits low THR-β activity, exacerbating mitochondrial dysfunction, lipotoxicity, and fibrosis.Research FindingsTHR-β Agonists Show Potential to Reduce Inflammatory Liver Fat and Fibrosis While Lowering Cholesterol and Other Atherogenic Lipids。Madrigal is currently conducting four Phase 3 clinical trials to evaluate the safety and efficacy of Resmetirom for the treatment of NASH: MAESTRO-NASH, MAESTRO-NAFLD-1, MAESTRO-NAFLD-OLE, and MAESTRO-NASH-OUTCOMES[8]。On April 18, 2023, Madrigal announced that Resmetirom received Breakthrough Therapy Designation from the FDA for the treatment of NASH patients with liver fibrosis.The company also announced that the Phase 3 MAESTRO-NASH biopsy trial has completed enrollment [9].Madrigal completed the rolling submission of the NDA for Resmetirom to the U.S. FDA in July 2023 for the treatment of adult patients with NASH and liver fibrosis. On September 13, 2023, Madrigal announced that the FDA had accepted the NDA for Resmetirom for the treatment of adult patients with NASH and liver fibrosis for review.FDA Grants Priority Review, PDUFA Date Set for March 14, 2024[10]。On November 10, 2023, Madrigal Pharmaceuticals announced new data from the Phase 3 MAESTRO-NASH trial of resmetirom:The vast majority (>70%) of patients treated with resmetirom 100mg achieved a ≥30% reduction in MRI-PDFF, meeting the primary liver biopsy endpoint and the key secondary endpoint of lowering low-density lipoprotein cholesterol., demonstrating the broad therapeutic effects of Resmetirom on non-invasive measures of liver health [11].
Sotatercept, originally developed by Acceleron Pharma, is a potential "First-in-class" type IIA activin receptor (ACVR2A) fusion protein, consisting of the extracellular domain of human Activin receptor IIA fused with the Fc domain of IgG1.Block the binding of activin to receptors on the cell membrane, thereby reducing activin-mediated signal transduction.In September 2021, Merck acquired Acceleron for $11.5 billion, gaining access to the newly approved anemia drug Reblozyl and the investigational pulmonary arterial hypertension drug sotatercept.。As early as April 2020, Acceleron Pharma, Inc. received FDA Breakthrough Therapy designation,For the treatment of pulmonary arterial hypertension（PAH），Becomes the First PAH Therapy in Development to Receive Breakthrough Therapy Designation[12]。2023Year8Month1On [date], Merck released2023In the financial report for the first half of the year, it was stated that they had submitted toFDASubmissionSotaterceptUsed for treatmentPAHBiologics License Application (BLA）。PAHIt is a rare, progressive, life-threatening vascular disease characterized by constriction of the small pulmonary arteries and elevated blood pressure in the pulmonary circulation. There are approximately40,000Humans suffer fromPAH. For many patients, this disease progresses rapidly.PAHIt puts severe strain on the heart, leading to restricted physical activity, heart failure, and a reduced life expectancy.PAHPatient's5The annual mortality rate is approximately43%。On September 28, 2023, Merck & Co., Inc. announcedFDA Has AcceptedSotaterceptPriority Review for BLA to Treat PAH Adult Patients; FDA Sets PDUFA Date for March 26, 2024[13]。The priority review was based on data from the Phase 3 STELLAR trial: Sotatercept demonstrated statistically significant and clinically meaningful improvements in 6-minute walking distance (6MWD) and in 8 of the 9 secondary endpoints (Figure 3) [14].
Figure 3. Change in 6-minute walk distance at Week 24
VadadustatIt was developed by Otsuka Pharmaceutical Co., Ltd. as an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, has been2020Year6Approved in Japan in the month, for the treatment of chronic kidney disease (CKD) in adult patients.CKD）Related Anemia.HIF-PHI is designed to mimic the body's response to lower oxygen levels, such as when a person is at high altitude.The body naturally responds to lower oxygen levels by increasing the availability of HIF, a protein that coordinates the gene expression responsible for erythropoietin synthesis and iron metabolism regulation.Inhibition of HIF-PH can lead to increased erythropoiesis and improved oxygen delivery to tissues.The discovery of HIF has laid the foundation for helping to understand the central role of oxygen sensing in many diseases, including anemia caused by CKD.As early as 2021,The New England Journal of Medicine published the results of a study on Vadadustat for the treatment of renal anemia in patients with chronic kidney disease (CKD) and those on dialysis:In two studies targeting dialysis-dependent chronic kidney disease (INNO2In a randomized (1:1), global, Phase 3, open-label, sponsor-blinded, parallel-group, active-controlled non-inferiority trial in VATE patients, vadadustat was non-inferior to darbepoetin alfa in terms of cardiovascular safety and hematological efficacy.。On September 29, 2023, Sarnak et al. published the latest progress on Vadadustat research in the Nephrology Dialysis Transplantation (NDT) journal.The study results showed:In patients receiving peritoneal dialysis, the difference in mean change in hemoglobin concentration during the initial evaluation period was -0.10 g/dL (95% CI -0.33, 0.12).The incidence rates of treatment-emergent adverse events (TEAE) in the Vadadustat and Darbepoetin alfa groups were 88.2% and 95.5%, respectively, with serious TEAEs at 52.6% and 73.2%, respectively (Figure 4) [15].The results showed thatIn Phase 3 INNO2In the subgroup of patients receiving peritoneal dialysis in the VATE trial, the safety and efficacy of vadadustatDarbepoetin alfaSimilar。
Figure 4. Phase 3 INNO2VATE Trial Results
In March 2021, Akebia submitted toFDAThe NDA for Vadadustat was submitted, but on March 29, 2022, the FDA rejected the NDA for Vadadustat.In October 2023, Akebia resubmitted the NDA for Vadadustat to the FDA for the treatment of anemia due to CKD in adult patients undergoing dialysis, with the FDA setting the PDUFA date for March 27, 2024.[16]。
Donanemab
Donanemab, developed by Eli Lilly, is abMonoclonal antibody drugs for the treatment of Alzheimer's disease.The pathogenesis of Alzheimer's disease remains unclear, but the currently widely recognized mechanism involves an imbalance in the production and clearance of Aβ, hyperphosphorylation of Tau protein, leading to inflammatory responses, neuronal death, and a series of pathological processes.On July 6, 2023, Eisai/Biogen's Lecanemab received full FDA approval.Became the first new AD therapy to receive full FDA approval in 20 years, marking the start of its true commercialization journey.Relative toLecanemab，The advantage of Donanemab is its longer injection interval, administered once every four weeks, while Lecanemab requires injection once every two weeks, which imposes a greater burden on patients and is a significant disadvantage.。
In 2022, Eli Lilly submitted to the FDAThe NDA of Donanemab, however, on January 19, 2023,FDA Rejects Accelerated Approval for Donanemab in Early Symptomatic Alzheimer’s Disease Due to Limited Patient Data with at Least 12 Months of Drug Exposure; No Other Deficiencies Found in Application.In July 2023,Lilly announceddonanemabInPositive Results Achieved in Phase 3 TRAILBLAZER-ALZ 2 Clinical Trial：1. Donanemab significantly slowed cognitive and functional decline in patients with early symptomatic Alzheimer's disease who are amyloid-positive and reduced the risk of disease progression; 2. Nearly half of the participants in the early stages of the disease who received Donanemab showed no clinical progression at one year; 3. Other subgroup analyses indicated that research participants in the earlier stages of the disease experienced greater benefits.The rate of decline slowed by 60% compared to placebo.; 4. During the trial, although many subjects completed the treatment at 6 months or 12 months, the therapeutic effect continued to increase relative to the placebo, supporting limited-time dosing [17].Lilly submitted the trial results as supplementary material to continue the NDA submission of Donanemab to the FDA.Donanemab is expected to be approved by the FDA for marketing in 2024.2023YearOctober 31, DonanemabIn ChinaThe listing application has beenCDE officially accepted.Previously, the NMPA granted Donanemab a Breakthrough Therapy Designation for the treatment of early Alzheimer's disease, including mild cognitive impairment caused by Alzheimer's disease and mild Alzheimer's disease.
Tovorafenib
PDUFA Date：2024.04.30
TovorafenibIs produced byDay One BiopharmaceuticalsAn orally administrable, brain-penetrantpan-RAFKinase inhibitor, capable of inhibiting wild-type and certain mutant forms ofBRAF、CRAFAndARAFProtein Kinase.October 30, 2023Day OneAnnouncement of FDA AcceptanceTovorafenibNew Drug Application for Recurrent or Progressive Pediatric Low-Grade Glioma (pLGG) Granted Priority Review, with a PDUFA Target Action Date of April 30, 2024.This NDA is based on the results of an open-label pivotal Phase 2 trial that evaluated Tovorafenib as a once-weekly monotherapy for patients aged 6 months to 25 years with recurrent or progressive pLGG.In November 2023, the results of the Phase 2 (FIREFLY-1) clinical trial of Tovorafenib were published in Nature Medicine. The study showed that Tovorafenib may be an effective therapy for treating recurrent/refractory pediatric low-grade gliomas with BRAF mutations, bringing new hope for the treatment of pediatric low-grade gliomas [18].
The results showed that: According to independent review assessment, in patients with high-grade glioma (RANO-HGG) in neuro-oncology, the overall response rate (ORR) was 67%, reaching the pre-specified primary endpoint of Group 1. The median duration of response (DOR) was 16.6 months, and the median time to response (TTR) was 3.0 months (secondary endpoint) (Figure 5).
Figure 5. Efficacy in RANO-HGG Patients
In pediatric neuro-oncology patients with low-grade gliomas (RAPNO), the ORR was 51%, the median DOR was 13.8 months, and the median TTR was 5.3 months (Figure 6).
Figure 6. Efficacy in RAPNO Patients
Imetelstat
PDUFA Date：2024.06.16
ImetelstatProduced byGeron CorporationDeveloped by“First-in-Class”Telomerase Inhibitor, For the treatment of low-risk myelodysplastic syndrome (MDS) Transfusion-dependent anemia in patients.2023In June,Geron To FDASubmittedImetelstatNDA`, subsequently`On August 21, Geron announced that the FDA had accepted the NDA for Imetelstat.WillPDUFA DateSetJune 16, 2024.This NDA is based on the results of the Phase 3 IMerge trial, in which the primary endpoint of 8-week transfusion independence (TI) in the imetelstat group was significantly higher than that in the placebo group (p<0.001). The median duration of TI for 8-week TI responders in the imetelstat group was nearly one year. Compared with placebo patients, the mean hemoglobin levels of patients treated with imetelstat increased significantly over time (p<0.001) [19].Bruedigam et al. reported in Nature Cancer the results of a randomized Phase II-like preclinical trial of imetelstat in patient-derived xenografts, showing that imetelstat effectively reduced acute myeloid leukemia (AML) burden and preferentially targeted subgroups with mutated NRAS and oxidative stress-related gene expression profiles [20].
Patritumab deruxtecan
PDUFA Date：2024.06.26
Patritumab deruxtecan (HER3-DXd) is an ADC drug targeting HER3, originally developed by Daiichi Sankyo. It is constructed by linking the HER3 monoclonal antibody patritumab with the topoisomerase I inhibitor deruxtecan via a maleimide-GGFG linker (Figure 7).
Figure 7. Structure of Patritumab deruxtecan
On October 20, 2023, Merck & Co. and Daiichi SankyoAstraZeneca and Daiichi Sankyo have reached a cooperation agreement worth up to 22 billion US dollars for the development and commercialization of three ADC drugs, including patritumab deruxtecan.On December 22, 2023, Daiichi Sankyo and Merck jointly announced that the BLA for patritumab deruxtecan had been accepted by the FDA and granted priority review.The indication is for EGFR-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) that has previously received at least two systemic treatments, becoming the first HER3 ADC to be submitted for marketing.The PDUFA date is June 26, 2024.BLABased onHERTHENA-Lung01Criticality2Main results of the phase trial andIASLC 2023World Lung Cancer Conference (#WCLC23`) were presented, and these results were simultaneously published in the Journal of Clinical Oncology.`Results from the HERTHENA-Lung01 study show that:The objective response rate (ORR) of patritumab deruxtecan treatment was 29.8% (95% CI: 23.9-36.2) in 225 patients with EGFR-mutated locally advanced or metastatic NSCLC whose disease progressed after EGFR TKI and platinum-based chemotherapy, including one complete response and 66 partial responses. The median duration of response was 6.4 months (95% CI: 4.9-7.8).[21]。
Main References
1. Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.
2.U.S. Food and Drug Administration Updates Prescription Drug User Fee Act (PDUFA) Action Date for Lifileucel for the Treatment of Advanced Melanoma3.Iovance Biotherapeutics Announces Clinical Data for Lifileucel in Advanced Mucosal Melanoma at the European Society for Medical Oncology (ESMO) Congress4.Minerva Neurosciences Announces Update on its New Drug Application (NDA) for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia5.Minerva Neurosciences Submits New Drug Application to FDA for Roluperidone for the Treatment of Negative Symptoms in Patients with Schizophrenia6.Michael Davidson et.al, Efficacy and Safety of Roluperidone for the Treatment of Negative Symptoms of Schizophrenia, Schizophrenia Bulletin vol. 48 no. 3 pp. 609–619, 20227.Minerva Neurosciences Receives Refusal to File Letter from FDA for its New Drug Application for Roluperidone for the Treatment of Negative Symptoms in Schizophrenia8.The Resmetirom Clinical Development Program: Leading the Way in NASH Research9.Madrigal Receives Breakthrough Therapy Designation from FDA for Resmetirom and Completes Enrollment of the Phase 3 MAESTRO-NASH Biopsy Trial10.Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis11.Madrigal Pharmaceuticals Presents New Data from the Phase 3 MAESTRO-NASH Trial Demonstrating Broad Treatment Effects of Resmetirom on Noninvasive Measures of Liver Health12.Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension13.Merck Receives Priority Review from FDA for New Biologics License Application for Sotatercept, an Activin Signaling Inhibitor to Treat Adults with Pulmonary Arterial Hypertension (PAH)14.M.M. Hoeper, et.al, Phase 3 Trial of Sotatercept for Treatment of Pulmonary Arterial Hypertension, N Engl J Med 2023;388:1478-90.15.Mark J. Sarnak et.al, Vadadustat for treatment of anemia in patients with dialysis-dependent chronic kidney disease receiving peritoneal dialysis, Nephrol Dial Transplant (2023) 38: 2358–236716.Akebia Receives FDA Acceptance of Resubmission to NDA of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease17.Results from Lilly's Landmark Phase 3 Trial of Donanemab Presented at Alzheimer's Association Conference and Published in JAMA18.Lindsay B Kilburn et.al, The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial, Nat Med. 2023 Nov 17.19.Geron Announces FDA Acceptance of New Drug Application for Imetelstat for the Treatment of Lower Risk MDS20.Claudia Bruedigam et.al, Imetelstat-mediated alterations in fatty acid metabolism to induce ferroptosis as a therapeutic strategy for acute myeloid leukemia, Nature Cancer (2023)21.Patritumab Deruxtecan Granted Priority Review in the U.S. for Certain Patients with Previously Treated Locally Advanced or Metastatic EGFR-Mutated Non-Small Cell Lung CancerMarch 8-9, XDC Innovation Unstoppable! 2024 BiG ADC Special Seminar
Keywords: Clinical Indication Expansion; Target & Project Initiation; Bispecific ADC; Combination Strategies; Next-Generation Linker-Payload; Radiopharmaceuticals
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June 13-14, A Decade of Drug Innovation, Sunrise in the East! BiG 10th Anniversary
Keywords: Source Innovation and Transformation, Innovative Technology Platforms (PROTAC/Molecular Glues; Bispecific ADC; Small Nucleic Acid Drugs; AI + Macromolecules), Clinical Research & International Development Strategies (Oncology/CNS/Autoimmunity/Metabolic Diseases)
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