eftansomatropin alfa (GX-H9) / Handok, Genexine, I-Mab, Jumpcan - LARVOL DELTA

Genexine Partner TJ Bio, 'GX-H9' China BLA Application [Google translation] (HIT News) - "Genexine...announced that its Chinese partner TJ Bio has completed the Biologics License Application (BLA) for its long-acting pediatric growth hormone ‘GX-H9’ to the China Center for Drug Evaluation (CDE)....According to the results of the phase 3 clinical trial conducted in China, GX-H9 demonstrated non-inferiority compared to the existing first-generation growth hormone drug, 'Norditropin' from Novo Nordisk."

China filing • Growth Hormone Deficiency (Pediatric)

Associations Between Self-Silencing and Inflammation in Midlife Women (NAMS 2024) - "Sources of Funding: NIH grants (RF1AG053504 and R01AG053504 to RCT & PMM), NHLBI (K24HL123565 and R01HL105647 to RCT)... Self-silencing was associated with increased hsCRP over five years, suggesting that emotional suppression in relationships may play a role in chronic inflammation. Future research should consider whether targeting self-silencing behaviors via psychosocial intervention to enhance relationship assertiveness skills can help reduce inflammation in women."

Clinical • Cardiovascular • CNS Disorders • Depression • Fibromyalgia • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Inflammation • Inflammatory Bowel Disease • Musculoskeletal Pain • Pain • Psychiatry • Rheumatology • CRP • IL6

Associations Between Self-Compassion and Sleep Among Midlife Women (NAMS 2024) - "Sources of Funding: NIH grants RF1AG053504 and R01AG053504(Thurston & Maki); K24HL123565(Thurston)... Greater self-compassion was associated with better sleep quality and fewer insomnia and depressive symptoms, after adjusting for confounders. Future research should test whether interventions to enhance self-compassion can improve mental health and sleep among midlife women, and clinicians may consider approaches that enhance self-compassion when treating poor sleep and depression in midlife women."

Clinical • CNS Disorders • Depression • Insomnia • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Relationships Between Emotion Regulation Strategies and Subjective and Objective Sleep Outcomes in Midlife Women (NAMS 2024) - "Sources of Funding: R01HL105647, R01AG053504, 2K24HL123565... Greater cognitive reappraisal is associated with improved sleep efficiency and increased expressive suppression is associated with prolonged sleep latency over midlife. Adaptive emotion regulation strategies may help promote healthy sleep among midlife women as they age."

Clinical • CNS Disorders • Depression • Mood Disorders • Obstructive Sleep Apnea • Psychiatry • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Associations Between Self-Compassion and Inflammation Among Midlife Women (NAMS 2024) - "Sources of Funding: NIH grants (RF1AG053504 and R01AG053504 to RCT & PMM), NHLBI (K24HL123565 and R01HL105647 to RCT)... Greater self-compassion was associated with reduced IL-6, not with hsCRP, after adjusting for covariates. Depression was a significant mediator of the relationship between self-compassion and IL-6. Practicing self-compassion may minimize the body's biological and psychological stress responses, promoting overall health."

Clinical • Cardiovascular • CNS Disorders • Depression • Immunology • Infectious Disease • Inflammation • Psychiatry • CRP • IL6

A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=168 | Completed | Sponsor: I-Mab Biopharma Co. Ltd. | Recruiting ➔ Completed

Trial completion • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

Molecular Characteristics of Bovine Viral Diarrhea Virus Strains Isolated from Persistently Infected Cattle. (PubMed, Vet Sci) - "The new strains were designated as BVDV TJ2101, TJ2102, TJ2103, TJ2104, TJ2105, TJ2106, TJ2107, TJ2108 and TJ2109. In conclusion, the present study has identified nine strains of BVDV from persistently infected cattle in China. Further studies on the virulence and pathogenesis of these new strains are recommended."

Journal

I-Mab (NASDAQ:IMAB) Q4 2022 Earnings Call Transcript (Insider Monkey) - "Andrew Zhu...I want to take this opportunity to discuss our key business update and major progress in core asset development for the year ended December 31st, 2022. Since the start of 2022, the company faced multiple challenges, including, but not limited to geopolitical issues such as ADR delisting risks, macroeconomic factors, including interest rate hikes and COVID-19 pandemic. In response to these challenges, the company made several strategic efforts to reposition the overall business and prioritize its pipeline. These measures resulted in a streamlined corporate structure and workforce as well as focused development of five key assets, leading to a significant reduction in the cash burn rate in 2022 and beyond."

Media quote

I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Year Ended December 31, 2022 (PRNewswire) - "'Going into 2023, we are now in a strong position to deliver on our innovative pipeline and corporate milestones, as well as to make expected progress in global partnerships and commercial partnerships given that business development remains a key strategic priority of the Company. We will stay laser-focused on creating value for our shareholders while extending the cash runway to support key business operations in the coming years,' Dr. Zhu concluded."

Media quote

I-Mab Provides Business and Corporate Updates and Reports Financial Results for the Year Ended December 31, 2022 (PRNewswire) - "As the studies progress, the Company expects to have two potential near-term BLA submissions in China (potentially by the end of 2023 or early 2024 for eftansomatropin alfa and at a later time for felzartamab), two key assets entering into Phase 3 or pivotal trials in China (lemzoparlimab for myelodysplastic syndromes (MDS) in Phase 3 and uliledlimab for NSCLC in a pivotal clinical trial) and one asset entering into Phase 2 (givastomig) in 2023....Phase 3 trial for pediatric growth hormone deficiency (PGHD)...The study aims to evaluate the efficacy, safety, and pharmacokinetics (PK) of eftansomatropin alfa in PGHD, as compared to Norditropin^®, a daily rhGH marketed in China. The study is on track, and the final dataset is anticipated in the second half of 2023, which is expected to be followed by a BLA submission by the end of 2023 or early 2024."

New P2 trial • New P3 trial • Non-US regulatory • Trial status • Growth Hormone Deficiency (Pediatric) • Hematological Malignancies • Lung Cancer • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Oncology

A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3 | N=165 | Recruiting | Sponsor: I-Mab Biopharma Co. Ltd. | Trial completion date: Mar 2023 ➔ Jul 2023 | Trial primary completion date: Feb 2023 ➔ Jul 2023

Trial completion date • Trial primary completion date • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

I-Mab concludes subject enrolment in Phase III PGHD treatment trial (Clinical Trials Arena) - "I-Mab president Dr Andrew Zhu said: 'We are excited by having achieved this important milestone as we are now so close to offering this differentiated therapy to patients."

Media quote

A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3; N=165; Recruiting; Sponsor: I-Mab Biopharma Co. Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

A Study to Evaluating the Efficacy and Safety of Recombinant Long-acting Human Growth Hormone (TJ101) in Children With Growth Hormone Deficiency (clinicaltrials.gov) - P3; N=165; Not yet recruiting; Sponsor: I-Mab Biopharma Co. Ltd.

Clinical • New P3 trial • Endocrine Disorders • Growth Hormone Deficiency • Growth Hormone Deficiency (Pediatric) • Pediatrics • IGF1

[VIRTUAL] 24-Month Efficacy and Safety of Once Weekly and Every Other Week Administration of GX-H9, Hybrid FC-Fused Long-Acting Human Growth Hormone: A Phase 2 Study in Children With Growth Hormone Deficiency (ENDO-I 2020) - "Subjects switched from Genotropin® in the second year, also showed substantial catch-up growth indicated by improvement in height SDS. GX-H9 has a unique potential to be a convenient long-term GH providing not only weekly but also twice-monthly treatment."

Clinical • Late-breaking abstract • P2 data • Endocrine Disorders • Growth Hormone Deficiency • IGF1

Dose Finding Study of GX-H9 in Paeditaric Patients With Growth Hormone Deficiency (clinicaltrials.gov) - P2; N=56; Completed; Sponsor: Genexine, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2019 ➔ May 2019

Clinical • Trial completion • Trial completion date • Endocrine Disorders • Growth Hormone Deficiency • IGF1 • IGFBP3

24-Month Efficacy and Safety of Once Weekly and Every Other Week Administration of GX-H9, Hybrid FC-Fused Long-Acting Human Growth Hormone: A Phase 2 Study in Children With Growth Hormone Deficiency (ENDO 2020) - "Subjects switched from Genotropin ® in the second year, also showed substantial catch-up growth indicated by improvement in height SDS. GX-H9 has a unique potential to be a convenient long-term GH providing not only weekly but also twice-monthly treatment."

Clinical • Late-breaking abstract • P2 data • IGF1