REMEGEN | MedPath

Pfizer Enters $6 Billion Licensing Deal with China's 3SBio for Novel Cancer Drug

3 days ago

• Pfizer has secured global rights (excluding China) to 3SBio's experimental cancer drug SSGJ-707 for $1.25 billion upfront, with potential additional payments of up to $4.8 billion based on developmental milestones. • SSGJ-707 is currently being evaluated for multiple cancer types including non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors, with Phase III trials in China planned to begin this year. • The deal includes a $100 million equity investment in 3SBio by Pfizer, with manufacturing planned at Pfizer's facilities in North Carolina and Kansas following FDA clearance of the Investigational New Drug application.

China Approves Remegen's Disitamab Vedotin for HER2-Positive Advanced Breast Cancer with Liver Metastasis

9 days ago

• China's National Medical Products Administration (NMPA) has approved Remegen's antibody-drug conjugate disitamab vedotin (RC-48) for patients with HER2-positive advanced breast cancer with liver metastasis. • The approval marks a significant advancement in targeted therapy options for Chinese patients with advanced breast cancer, particularly addressing the challenging subset with liver metastases. • Disitamab vedotin joins the growing field of antibody-drug conjugates targeting HER2, offering a new treatment approach in a market where targeted therapies for metastatic breast cancer remain an area of high unmet need.

Lupus Nephritis Market Expected to Grow as Novel Therapies Enter Clinical Trials

14 days ago

• The global lupus nephritis market is projected to grow significantly by 2034, with the United States accounting for over 80% of the current $1.12 billion market share across major regions. • Several innovative therapies are advancing through clinical trials, including CAR-T cell treatments from companies like Allogene Therapeutics, Adicet Bio, and Caribou Biosciences, which received FDA Fast Track designations. • Key pharmaceutical players including Aurinia Pharmaceuticals, AstraZeneca, and Roche are developing treatments such as voclosporin, anifrolumab, and obinutuzumab to address the significant unmet needs in lupus nephritis management.

RemeGen's Telitacicept Shows Remarkable 98% Response Rate in Phase 3 Trial for Generalized Myasthenia Gravis

2 months ago

• Telitacicept demonstrated a 98.1% response rate in reducing MG-ADL scores by ≥3 points at Week 24, potentially positioning it as best-in-class among treatments for generalized myasthenia gravis. • The novel fusion protein targeting both BLyS and APRIL showed significant improvements in both patient-reported outcomes (MG-ADL) and objective measures (QMG), with benefits emerging as early as 4 weeks after treatment initiation. • RemeGen's BLA for Telitacicept has been accepted by China's regulatory authorities with approval expected in Q2 2025, while a global Phase 3 trial is advancing to validate efficacy in a broader patient population.

Pipeline Progress: Over 25 New Therapies in Development for Metastatic Liver Cancer

2 months ago

• DelveInsight's latest report reveals a robust pipeline with over 20 companies developing 25+ therapies for metastatic liver cancer, offering new hope for patients with limited treatment options. • Several promising clinical trials are underway in 2025, including studies evaluating novel combinations such as AK104 plus lenvatinib, tislelizumab with lenvatinib, and triplet therapy of nivolumab, relatlimab and bevacizumab. • Key emerging therapies include exoASO-STAT6 targeting tumor-associated macrophages, STP705 dual TGF-ß1/COX-2 inhibitor, and ONCR-177, an oncolytic viral immunotherapy expressing five transgenes to fight tumors through multiple mechanisms.

Rheumatoid Arthritis Market Set to Reach $34.7 Billion by 2035, Driven by Novel Therapies and Rising Obesity Rates

3 months ago

• The global rheumatoid arthritis market is projected to grow from $28 billion in 2024 to $34.7 billion by 2035, with a CAGR of 1.97%, fueled by advancements in biologics and targeted therapies. • Rising obesity rates, sedentary lifestyles, and urbanization are significantly contributing to increased rheumatoid arthritis prevalence, while also reducing the efficacy of some treatments. • Novel treatment approaches including JAK inhibitors, monoclonal antibodies, and emerging therapies like R-2487 and IMVT-1402 are transforming the treatment landscape with more targeted mechanisms of action.

FDA Tightens Requirements for China-Developed Drugs, Mandates Multi-Regional Trials

3 months ago

• The FDA has rejected multiple China-developed drugs, including Hutchmed's surufatinib and Eli Lilly's sintilimab, citing concerns over single-country clinical trial data. • At least 25 oncology drug applications from China face increased scrutiny, with the FDA emphasizing the need for multi-regional trials to ensure data generalizability across diverse populations. • The regulatory shift impacts China's growing biopharma sector, which has attracted significant Western partnerships, including Merck's recent $1.4 billion deal with Sichuan Kelun Pharmaceutical.

Phase II Trial Shows Breakthrough 63.6% Response Rate for Novel Bladder Cancer Combination Therapy

3 months ago

• Disitamab Vedotin combined with Toripalimab achieved a 63.6% pathological complete response rate in muscle-invasive bladder cancer patients, nearly doubling traditional chemotherapy outcomes. • The clinical trial demonstrated strong efficacy across all HER2 expression levels, with HER2 IHC 3+ patients showing an exceptional 84.6% complete response rate. • The treatment showed favorable safety with only 27.7% grade 3 or higher adverse events, significantly lower than conventional chemotherapy's 40-50% rate.

DelveInsight Report: Over 50 Pipeline Drugs in Development for Urothelial Carcinoma Treatment

4 months ago

• DelveInsight's latest pipeline analysis reveals 40+ pharmaceutical companies actively developing 50+ therapeutic candidates for urothelial carcinoma treatment, indicating robust research activity in this space. • Major pharmaceutical companies including AstraZeneca, Seagen, and Janssen are advancing promising therapies, with notable candidates like disitamab vedotin and cetrelimab in late-stage development. • Recent clinical trials include Seagen's Phase 2 study of disitamab vedotin with pembrolizumab, and Roche's Phase 1b/II umbrella study investigating multiple combination therapies for advanced urothelial carcinoma.

Seagen Secures $2.6B Deal with RemeGen for Novel HER2-Targeting Cancer Drug

4 months ago

• Seagen has entered a $2.6 billion licensing agreement with Chinese biotech RemeGen for disitamab vedotin, a HER2-targeting antibody-drug conjugate, with $200 million paid upfront. • The drug has already received conditional approval in China for HER2-positive gastric cancer and breakthrough designation from FDA for bladder cancer. • This strategic move positions Seagen to compete with established HER2-targeting ADCs like AstraZeneca/Daiichi Sankyo's Enhertu and Roche's Kadcyla in multiple cancer indications.

Pfizer to Present Landmark Survival Data for Cancer Therapies at ASCO GU 2025 Symposium

4 months ago

• Pfizer will showcase over 20 abstracts at ASCO GU 2025, including pivotal Phase 3 TALAPRO-2 trial results demonstrating significant overall survival benefits for TALZENNA-XTANDI combination in prostate cancer. • Updated analysis from Phase 3 EV-302 trial confirms sustained survival advantage of PADCEV with pembrolizumab in advanced urothelial cancer, reinforcing its position as a first-line treatment standard. • Novel investigational therapy mevrometostat shows promising progression-free survival data when combined with XTANDI in metastatic castration-resistant prostate cancer, advancing Pfizer's genitourinary cancer pipeline.

Global Diabetic Retinopathy Clinical Trials Landscape Analysis Reveals Key Research Trends for 2024

4 months ago

• A comprehensive analysis of global diabetic retinopathy clinical trials has been released, offering insights into trial distribution across G7 and E7 countries and various research phases. • The report highlights significant trends in trial enrollment patterns over the past five years, providing valuable data for healthcare stakeholders and pharmaceutical companies. • The analysis covers detailed assessment of trial statuses, sponsor types, and endpoint evaluations, helping identify key opportunities and challenges in diabetic retinopathy research.

Advancements in Breast Cancer Research Unveiled at SABCS 2024

5 months ago

• The PATINA trial suggests palbociclib with anti-HER2 and endocrine therapy may become a new standard for HR+, HER2+ metastatic breast cancer. • COMET trial indicates active monitoring is comparable to surgery for low-risk DCIS, offering a potential alternative management option. • OlympiA trial's long-term results reinforce olaparib's role in preventing recurrence and highlight the importance of BRCA testing for early-stage breast cancer.

Multispecific Antibodies Market Set to Exceed $40 Billion as Next-Generation Cancer Therapies Advance

5 months ago

• The multispecific antibodies market has surpassed $8.6 billion in sales as of Q3 2024, with 16 approved therapies demonstrating efficacy across oncology and other therapeutic areas. • Bispecific antibodies currently dominate the market, while more complex trispecific and tetraspecific antibodies are emerging in early development phases with potential for enhanced therapeutic advantages. • Over 900 multispecific antibodies are currently in clinical trials, reflecting substantial investment from pharmaceutical companies and biotechnology firms seeking to address complex diseases through multi-target approaches.

Disitamab Vedotin Shows Promise in HER2-Positive Breast Cancer with Liver Metastasis

5 months ago

• Disitamab Vedotin (DV) significantly improved progression-free survival (PFS) compared to Lapatinib plus Capecitabine in HER2-positive advanced breast cancer with liver metastasis. • The Phase III study (RC48-C006) is the first global prospective, randomized trial demonstrating the efficacy of a HER2-targeting ADC in this patient population. • DV demonstrated a manageable safety profile, consistent with previous experience, offering a potential new treatment option for previously treated patients. • The Biologics License Application for Disitamab Vedotin has been accepted and granted priority review by China's National Medical Products Administration.

Disitamab Vedotin Plus Toripalimab Shows Promise in Muscle-Invasive Bladder Cancer

5 months ago

• Phase 2 trial RC48-C017 shows promising efficacy and acceptable safety of neoadjuvant disitamab vedotin plus perioperative toripalimab in HER2-expressing muscle-invasive bladder cancer (MIBC). • Pathological complete response (pCR) was observed in 63.6% of patients who underwent radical cystectomy, with a pathological response rate of 75.8%. • The 12-month event-free survival (EFS) rate was 90.5%, and the 12-month overall survival (OS) rate was 95.5% in the intent-to-treat (ITT) population. • Treatment-related adverse events were manageable, with no new safety signals identified, supporting the potential of this combination as a neoadjuvant treatment option.

Lupus Nephritis Clinical Trial Landscape Shows Active Development

6 months ago

• The lupus nephritis clinical trial pipeline is robust, featuring over 30 companies developing more than 35 therapies. • Key players like AstraZeneca, Roche, and Novartis are advancing drugs such as Anifrolumab and Ianalumab through clinical trials. • Recent trial activities include Adicet Bio dosing the first patient in a Phase I trial of ADI-001 and Kyverna presenting updated clinical data on KYV-101. • Various therapeutic modalities, including monoclonal antibodies and cell therapies, are being explored across different clinical stages.

Emerging Intravesical and Systemic Therapies Revolutionize Bladder Cancer Treatment

6 months ago

• Intravesical therapies like cretostimogene and TAR-200 show promising complete response rates in BCG-unresponsive NMIBC, but duration of response remains a key factor. • Perioperative systemic therapies, including neoadjuvant chemo-immunotherapy with durvalumab, aim to improve event-free and overall survival in muscle-invasive urothelial carcinoma. • Antibody-drug conjugates (ADCs) targeting Nectin-4 and HER2, such as enfortumab vedotin and disitamab vedotin, demonstrate significant potential in metastatic urothelial cancer. • Novel strategies, including dual-targeting antibodies and combinations of ADCs with immunotherapies, are being explored to further enhance treatment efficacy and overcome resistance.

Ziftomenib Shows Promise in AML: Kura Oncology and Kyowa Kirin Advance to Phase 3 Trials

6 months ago

• Kura Oncology and Kyowa Kirin's ziftomenib demonstrates statistically significant efficacy in Phase 2 trial for relapsed/refractory NPM1-mutant acute myeloid leukemia (AML). • The companies plan to submit a New Drug Application (NDA) to the FDA in the second quarter of 2025, seeking approval for ziftomenib in R/R NPM1-m AML. • Phase 3 trials are set to begin in the second half of 2025, evaluating ziftomenib in combination with intensive and non-intensive chemotherapy regimens for newly diagnosed AML. • FDA feedback supports potential accelerated approval pathways in both intensive and non-intensive treatment settings, based on MRD negative CR and CR endpoints.

Multiple Sclerosis Pipeline Shows Promise with Novel Therapies in Development

6 months ago

• The multiple sclerosis (MS) therapeutic landscape is expanding, with over 80 active pipeline therapies currently in development by more than 75 companies. • Recent clinical trials have yielded mixed results, with some therapies showing promise in specific MS subtypes, such as non-relapsing secondary progressive MS (nrSPMS). • Regulatory milestones have been achieved, including FDA approval for new formulations and fast-track designations for therapies targeting progressive MS. • Emerging therapies in the MS pipeline include monoclonal antibodies, oral treatments, and CAR-T cell therapies, offering diverse mechanisms of action and routes of administration.