An Randomized, Open-label, Multicenter Phase 2 Study Comparing the Efficacy and Safety of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin Monotherapy in Subjects With Endocrine-resistant Hormone Receptor-positive, HER2-Low Unresectable Locally Advanced or Metastatic Breast Cancer

This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast cancer.

Start Date20 Dec 2024

Sponsor / Collaborator

RemeGen Co., Ltd.

NCT06642545 / Not yet recruitingPhase 2

A Randomized, Open-label, Controlled, Multicenter Phase II Study to Evaluate the Efficacy and Safety of Disitamab Vedotin Combined With RC148 Versus Albumin-bound Paclitaxone Alone or in Combination With Toripalimab in Subjects With HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

Evaluating the Efficacy of Disitamab Vedotin in Combination with RC148 Compared to Albumin-bound Paclitaxone Monotherapy or in Combination with Toripalimab for Subjects with HR-negative, HER2-low Expressing Unresectable Locally Advanced or Metastatic Breast Cancer

Start Date01 Nov 2024

Sponsor / Collaborator

RemeGen Co., Ltd.

NCT06558682 / Not yet recruitingNot ApplicableIIT

Disitamab Vedotin Combined with Cisplatin for Neoadjuvant Therapy in Locally Advanced Cervical Cancer: a Prospective, Single-arm Clinical Trial

In the comprehensive dataset of clinical diagnoses and treatments for cervical cancer in China, 49.8% of patients with stage IB3 and IIA2 receive surgical intervention following neoadjuvant chemotherapy. This indicates a pressing need to optimize neoadjuvant chemotherapy regimens for locally advanced cervical cancer. While paclitaxel combined with cisplatin is the conventional approach, 9.8% to 30.6% of patients demonstrate suboptimal responses, with a pathological complete response rate of approximately 10%.
Currently, the efficacy of antibody-drug conjugates in neoadjuvant chemotherapy for cervical cancer remains unexplored. This study seeks to address this gap by evaluating the combination of Disitamab Vedotin and Cisplatin in patients with stage IB3 and IIA2 cervical cancer with positive HER2 expression.The study will assess the impact of this regimen on pathological complete response rates, surgical complications, surgical resection rates, and overall survival.

Start Date20 Oct 2024

Sponsor / Collaborator

Qilu Hospital of Shandong University

[+1]

100 Clinical Results associated with RemeGen Co., Ltd.

0 Patents (Medical) associated with RemeGen Co., Ltd.

Literatures (Medical) associated with RemeGen Co., Ltd.

01 Sep 2024·Ophthalmology and Therapy

Safety and Efficacy of Multiple Escalating Doses of RC28-E for Neovascular Age-Related Macular Degeneration: A Phase 1b Trial

Article

Author: Wang, Wenxiang ; Bi, Yanlong ; Chen, He ; Wu, Chan ; Chen, Youxin ; Dai, Hong ; Zhu, Dan ; Zhang, Han ; Lu, Yingyi ; Li, Lin ; Li, Zhuo ; Jiang, Qin ; Yu, Xiaobing ; Fang, Jianmin ; Liu, Xiaoling ; Zhang, Yifan ; Ha, Shaoping

INTRODUCTIONTo assess the safety and efficacy of repeated intravitreal injections of RC28-E, a novel bispecific antibody that simultaneously binds vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF) in patients with neovascular age-related macular degeneration (AMD). This was a prospective, multicenter, open-label clinical trial; 37 patients with choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) letter scores between 73 and 34 were enrolled.METHODSTreatment regimens consisted of a 3-month loading phase and a pro re nata (PRN) maintenance phase. This study included three treatment groups: the 0.5, 1.0, and 2.0 mg RC28-E groups, with escalating doses ranging from 0.5 to 2.0 mg. Patients were evaluated monthly for 48 weeks. Safety was assessed based on ocular and systemic adverse events (AEs), pharmacokinetic characteristics, and the presence of anti-RC28-E antibodies. Efficacy was assessed using the mean change in BCVA and central subfield thickness (CST) from baseline to week 48.RESULTSMost AEs were mild or moderate. The most common AE was a minor injection-related subconjunctival hemorrhage (16.2%). The AEs did not increase with dose or repeated injections. At week 48, mean improvements in BCVA from baseline in the 0.5, 1.0, and 2.0 mg groups were 6.1 ± 8.3, 9.9 ± 10.7, and 7.6 ± 9.38 letters, respectively; mean reductions in CST in the three groups were 112.1 ± 160.5, 175.1 ± 212.4, and 128.7 ± 145.8 μm, respectively. The serum RC28-E concentrations in 95% of the patients were below the quantification limit of the assay. No significant change from baseline was observed in the mean plasma concentrations of VEGF or FGF over the 48 weeks of treatment. Pre-treatment antibodies to RC28-E were detected in 1 of the 37 patients. Antibodies to RC28-E were detected in two patients after dosing with RC28-E for 48 weeks.CONCLUSIONRC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters.

01 Jun 2024·Journal of Clinical Oncology

The efficacy and safety of RC88 in patients with ovarian cancer, non-squamous-non-small-cell lung-carcinoma and cervical cancer: Results from a first-in-human phase 1/2 study.

Author: Shi, Yuankai ; Luo, Suxia ; Tang, Dihong ; Liu, Heping ; Zhang, Youzhong ; Dang, Qi ; Liu, Beisong ; Huang, Dingzhi ; Huang, Yi ; Ren, Xiubao ; Liu, Baorui ; Li, Guiling ; Liu, Yutao ; Huang, Yu ; Zhou, Jin ; Zhao, Yuguang ; Li, Qingshui ; Wang, Yanjie ; Fang, Jianmin ; Yang, Runxiang

5551 Background: RC88 is a first-in-class, antibody-drug conjugate (ADC) targeting mesothelin (MSLN) with the payload of Monomethyl auristatin E. MSLN, a glycosylphosphatidylinositol-anchored protein, is overexpressed in several solid tumors with limited expression in normal tissues. RC88-C001 is a single-arm, open-label, multi-center phase 1/2 study evaluating RC88 in patients (pts) with MSLN-expressing advanced solid tumor (NCT04175847). This abstract mainly reports the efficacy results from the dose expansion part (phase 2) of the study. Methods: Pts with MSLN-expressing advanced malignant solid tumors that have failed after standard therapies were enrolled in this study. MSLN was tested by IHC. For phase 2 study, the primary endpoint was ORR by investigator per RECIST v1.1 with secondary endpoints including DCR, PFS, and safety. Results: As of 19 December, 2023, 164 pts with advanced solid tumor were enrolled. Dose escalation phase was completed, and 2.0 mg/kg and 2.5 mg/kg Q3W were expanded in phase 2. In ovarian cancer cohort, 60 pts were enrolled and all with 2+ or 3+ MSLN expression. Forty-two (70%) were FIGO stage IV. Thirty-three (55%) had prior bevacizumab, and 29 (48.3%) had prior PARPi. The number of previous lines of systemic therapy were 2-7. Fifty-four (90%) pts were platinum-resistant. Among the 43 pts with at least one post-baseline tumor assessment, the ORR was 37.2% (16/43). In pts with prior 2-4 lines of therapies, the ORR was 45.5% (10/22) in 2.0 mg/kg and 33.3% (2/6) in 2.5mg/kg. In non-squamous-non-small-cell lung-carcinoma, 26 pts progressed on previous systemic therapy were enrolled and 23 (88.4%) had received ≥ 2 lines of prior therapies. Twenty-three pts had one post-baseline tumor assessment; the ORR was 21.7% (5/23). Among the 15 pts without driver gene mutations, 11 (73%) had received prior platinum-doublet chemotherapy and PD-(L)1 inhibitor. The ORR was 33.3% (5/15) with 1 CR. In cervical cancer, 18 pts progressed on previous systemic therapy were enrolled. In 17 pts with one post-baseline tumor assessment, 11 (64.7%) had received ≥ 2 lines of prior therapies; 12 (70.5%) had prior platinum-doublet chemotherapy and PD-(L)1 inhibitor. The ORR was 35.3% (6/17). TEAEs were reported in 161 pts (98.2%), with 40.2% ≥grade 3 TEAEs. Twenty-three pts (14%) had SAE related to RC88. The most frequent TRAEs were white blood cell count decreased (46.3%), neutrophil count decreased (42.1%), anemia (34.1%), nausea (32.3%), and aspartate aminotransferase increased (31.1%). The overall safety profile was better in 2.0mg/kg than 2.5mg/kg, therefore 2.0mg/kg was chosen as RP2D in further studies in China. Conclusions: RC88 demonstrated tolerable safety and encouraging preliminary efficacy in MSLN-expressing solid tumors, warranting further investigations. Clinical trial information: NCT04175847 .

01 Jun 2024·Journal of Clinical Oncology

Evaluation of the effectiveness and safety of disitamab vedotin in HER2-expressing 2L recurrent or metastatic cervical cancer (r/mCC): Interim results of RC48-C018.

Author: Guo, Ruixia ; Sun, Li ; Lin, An ; Li, Qingshui ; Zhang, Youzhong ; An, Ruifang ; Huang, Yi ; Tang, Junying ; Miao, Jinwei ; Li, Guiling ; Ling, Yun ; Zhang, Keqiang ; Wang, Yanan ; Wu, Lingying ; Zhou, Haiwen ; Li, Xiumin ; Ying, Jianming ; Yuan, Guangwen ; Yang, Hongying ; Fang, Jianmin

5528 Background: Disitamab Vedotin (DV) is a HER2-targeted antibody-drug conjugate (ADC), and is approved in HER2-expressing gastric cancer and locally advanced or metastatic urothelial carcinoma. HER2 also shows certain expression in Gynecological malignant tumors. A phase 2, open-label, multicenter basket design study (NCT04965519) is currently underway to evaluate the efficacy and safety of DV monotherapy in the treatment of HER2-expressing gynecologic malignancies. Methods: The cervical cancer cohort includes patients (pts) with recurrent/metastatic cervical cancer (r/mCC) who failed with at least one-line platinum-containing standard treatment and had HER2 immunohistochemistry ≥1+. Pts received DV monotherapy administered intravenously at a dose of 2 mg/kg every 2 weeks until disease progression or intolerable toxicity. The primary endpoint is the objective response rate (ORR). Secondary endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: 25 r/mCC pts were enrolled and received at least one cycle of treatment. At baseline, the median age was 56 years (range: 35-66 years). The number of pts in the 2L, 3L, and 4L+ was 12(48%), 9 (36%), and 4 (16%), respectively. The majority of pts (n=16, 64%) had a baseline ECOG performance score of 1. 16 pts (64%) had squamous cell carcinoma as the baseline histological type, and 9 pts (36%) had adenocarcinoma. 10 pts (40%) had prior anti-PD-(L)1 therapy. As of Oct 31, 2023, the median follow-up was 8.67months (mo) (range 1.7-19.7). Among the 22 evaluable pts, the ORR was 36.4% (8/22), the confirmed ORR was 31.8% (7/22), the median time to response was 1.5 mo (range 1-3); the mDoR was 5.52 mo (95% CI: 2.10, NE). The DCR was 86.4% (19/22), and the mPFS was 4.37 mo (95% CI: 2.92, 6.90). The mOS was unmature (95% CI: 9.63, not available). 12-month OS rate was 66%(95%CI:35%,85%). Subgroup analysis showed ORRs of 20% (2/10), 50% (4/8), and 25% (1/4) in the 2L, 3L, and 4L+ pts, respectively; ORRs of 50% (6/12), 12.5% (1/8), and 0 (0/2) for pts with IHC scores of 1+, 2+, and 3+ respectively; ORRs of 42.9% (6/14) and 12.5% (1/8) for pts with squamous cell carcinoma and adenocarcinoma, respectively. Among all 25 enrolled r/mCC pts, the most common treatment-related AE included ALT increased (56%), AST increased (56%), and white blood cell count decreased (52%). Grade 3 or higher TRAEs included neutrophil count decreased (12%), ALT increased (8%). Two pts (8%) experienced treatment-related SAE. No DV-related deaths occurred. Conclusions: In the study, DV showed manageable safety and promising efficacy in HER2-expressing r/mCC pts who have failed from multiple lines of therapy. These results support further investigation for DV in r/mCC. Clinical trial information: NCT04965519 .

News (Medical) associated with RemeGen Co., Ltd.

29 Oct 2024

·www.prnewswire.com

RemeGen Announces the Acceptance of the Marketing Application of Telitaccept for the Treatment of Myasthenia Gravis in China

YANTAI, China, Oct. 29, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, 688331.SH), a commercial-stage biotechnology company, recently announced that the marketing application of Taicercept ® for the treatment of generalized myasthenia gravis (gMG) has been officially accepted by the Center for Drug Evaluation (CDE) of the China National Food and Drug Administration and has been included in the priority review and approval process. Myasthenia gravis (MG) is a rare chronic autoimmune disease that has been included in the First List of Rare Diseases in China. According to the Frost & Sullivan report, the global number of myasthenia gravis patients is expected to reach 1.5 million in 2025, and the number of patients in China is about 217,000. The disease involves immunoglobulin G (IgG) antibodies that disrupt synaptic transmission between nerves and muscles, leading to muscle weakness and, in severe cases, life threatening risks. More than 85% of patients develop generalized myasthenia gravis within 24 months of disease onset, characterized by extreme fatigue and significant difficulty with facial expression, speech, swallowing, and mobility. Currently, there is no satisfactory treatment for myasthenia gravis, and effective, safe and precise targeted biological agents have become a hot spot in the research and development of myasthenia gravis drugs. In recent years, B-cell targeted therapies have shown a good therapeutic prospect in myasthenia gravis treatment. Studies have found that compared with traditional immunotherapy, B-cell targeted therapies can significantly reduce the recurrence rate of myasthenia gravis, and the withdrawal rate is low. Teritacept is a dual target antibody fusion protein, which can target BLyS and APRIL at the same time, and directly attack the source of pathogenic antibodies -- B cells and plasma cells, thereby reducing the production of pathogenic antibodies and resulting in therapeutic effect. In August 2024, the company announced the completion of the domestic phase Ⅲ clinical trial of telitacept in the treatment of generalized myasthenia gravis. The results of the clinical study showed that telitacept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis. Internationally, the global multicenter phase Ⅲ clinical trial of gMG has achieved the first patient enrollment in the United States in August 2024. Telitacicept has been granted orphan drug and fast track status by the Food and Drug Administration (FDA) of the United States, and breakthrough therapy status by National Medical Products Administration (NMPA) of China. About Telitacicept (RC18) Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatment of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. It was granted complete marketing approval by China's National Medical Products Administration (NMPA) to treat systemic lupus erythematosus (SLE) in November 2023 and rheumatoid arthritis (RA) in July 2024. About RemeGen Co. Ltd. Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices in China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: SOURCE RemeGen Co., Ltd WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Orphan DrugImmunotherapyClinical ResultFast TrackBreakthrough Therapy

06 Aug 2024

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First patient enrollment in the U.S. - A milestone for the global multi-center phase Ⅲ clinical trial of telitacicept for myasthenia gravis

YANTAI, China, Aug. 6, 2024 /PRNewswire/ -- RemeGen Co. Ltd. ("RemeGen" or "the Company") (9995.HK, SHA:688331), a commercial-stage biotechnology company, announced that the company's self-developed BLyS/APRIL dual targeting fusion protein innovative drug telitacicept has achieved the first patient enrollment in the United States for its global multi-center phase III clinical trial for the treatment of generalized myasthenia gravis (gMG). This milestone marks an important step in the worldwide clinical development of telitacicept, which will bring new hope to myasthenia gravis patients globally. Previously, telitacicept was granted orphan drug and fast track status for myasthenia gravis indication by the US Food and Drug Administration (FDA) and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China. This global, multicenter, randomized, double-blind, placebo-controlled, phase III study aims to evaluate the efficacy and safety of telitacicept in the treatment of gMG. The trial plans to recruit 180 patients from multiple countries and regions around the world. Myasthenia gravis (MG) is a rare, chronic autoimmune disease that leads to impaired transmission at neuromuscular junctions, which can affect eye movement, swallowing, speech, general movement and respiratory function at varying degrees. According to the Frost & Sullivan report, the global number of myasthenia gravis patients is expected to reach 1.15 million in 2025, with about 70,000 in the United States and 22,000 in China. At present, the main treatment methods for myasthenia gravis include cholinesterase inhibitors, glucocorticoids and immunosuppressants. However, a substantial unmet medical need remains as there are many patients can not be effectively treated due to lack of efficacy, tolerability or contraindications of existing therapies. Telitacicept is a dual targeting antibody fusion protein that targets BLyS and APRIL at the same time, and directly attack the source of pathogenic antibodies -- B cells and plasma cells, thereby reducing the production of pathogenic antibodies and achieving its therapeutic purpose. Preliminary clinical studies have shown that telitacicept can continuously and effectively improve the clinical status of patients with generalized myasthenia gravis. Since its approval in China in March 2021, telitacicept has benefited more than 40,000 patients with excellent efficacy and safety. In China, in addition to the two approved indications of systemic lupus erythematosus and rheumatoid arthritis, telitacicept has the potential to be approved for myasthenia gravis, Sjogren's syndrome, IgA nephritis, and neuromyelitis optica in the coming years. About RemeGen Co. Ltd. Founded in 2008, RemeGen (9995.HK, SHA: 688331) is a leading biopharmaceutical company in China committed to providing solutions to the unmet clinical needs of patients suffering from life-threatening illnesses. RemeGen has research laboratories and offices throughout China and the United States. The company is committed to discovering, developing, and commercializing innovative and differentiated biologic drugs of significant clinical value in the key therapeutic areas of autoimmune, oncology, and ophthalmic diseases. For more details, please visit: About Telitacicept (RC18) Telitacicept (RC18) is RemeGen's proprietary novel fusion protein for the treatments of autoimmune diseases. It is constructed with the extracellular domain of the human transmembrane activator and calcium modulator and cyclophilin ligand interactor (TACI) receptor and the fragment crystallizable (Fc) domain of human immunoglobulin G(IgG). Telitacicept targets two cell-signaling molecules critical for B-lymphocyte development: B-lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL), which allows it to effectively reduce B-cell mediated autoimmune responses that are implicated in several autoimmune diseases. SOURCE RemeGen Co., Ltd

Phase 3Fast TrackOrphan DrugImmunotherapyDrug Approval

26 Jul 2024

·www.prnewswire.com

ReviR Therapeutics Raises $30 Million Series A Financing to Advance its Proprietary Oral Genetic Medicines for Multiple CNS Disorders

BRISBANE, Calif., July 26, 2024 /PRNewswire/ -- ReviR Therapeutics, an AI-enabled biotechnology company focused on developing small molecule RNA modulators for neurogenetic diseases, announced today that it has successfully completed a $30 million Series A financing, bringing the total raised so far to $54M, including the seed financing in 2021. The financing was led by Lapam Capital with strong support from existing investors CDH Investments, 5Y Capital, and Yael Capital, as well as new participants XtalPi and the Charcot-Marie Tooth Research Foundation (CMTRF). These funds will be used to further augment ReviR's AI-driven drug discovery VoyageR platform, which will be leveraged to advance proprietary chemical matter for novel and undruggable targets and to support clinical development of treatments for Huntington's disease (HD), Charcot-Marie-Tooth disease (CMT), amyotrophic lateral sclerosis (ALS), and other neurological disorders. Since its founding in 2021, ReviR Therapeutics has assembled an expert global drug discovery team and built a robust customized AI platform. ReviR's platform strategy focuses on developing non-invasive, orally administered genetic therapies that use small molecules to regulate RNA splicing and influence protein expression. This approach leverages the VoyageR platform to develop potent, safe, and selective RNA splicing modulators for a broad range of diseases. While over 80% of disease-related proteins are considered "undruggable", ReviR's novel genetic therapies target RNA, upstream of protein synthesis to stop causal disease progression. Other genetic therapy modalities often encounter delivery challenges, particularly with crossing the blood-brain barrier, and can be invasive, especially for CNS diseases. ReviR is currently focused on treating neurodegenerative diseases and rare genetic disorders while exploring partnerships in the fields of oncology, immunology & inflammation, and metabolic diseases. Dr. Peng Yue, Co-founder and CEO of ReviR Therapeutics, stated, "Neurological diseases affect a large number of individuals worldwide, many of which do not have disease modifying therapies available. ReviR is dedicated to developing accessible, safer genetic therapies that can be administered orally. We value the support from new and existing investors as we progress from initial platform development to clinical trials, continually enhancing our AI platform and advancing our pipeline. As we move forward, we will continue to raise funds as an extension to our Series A to support additional programs entering clinical trials." Mr. Zhihua Yu, Founding Partner of Lapam Capital, commented, "Small molecule targeting RNA represents a highly challenging and innovative field. RNA targets offer greater potential compared to protein targets, but also present higher development difficulties. We have great confidence in ReviR's platform, which can identify potential RNA targets and efficiently develop safe and effective RNA-targeted therapies. This enables the development of orally administrable small molecule drugs for previously undruggable targets. ReviR has built a team with extensive experience in computational biology, RNA biology, and drug discovery, showcasing exceptional execution capabilities. We are confident the company will advance its pipeline to clinical trials soon, benefiting patients worldwide. We will continue to support ReviR with our experience and resources as it grows." Dr. Shuhao Wen, Co-founder and Chairman of XtalPi, added, "At XtalPi, we recognize the immense potential of small molecule targeting RNA to significantly expand the boundaries of drug discovery. Our collaboration with ReviR, leveraging XtalPi's cutting-edge AI and robotics drug discovery solutions with ReviR's specialized capabilities in RNA structural analysis, small molecule screening, and target engagement evaluation, has already yielded promising pipeline results. Our collective expertise is aimed at propelling these innovations into clinical research, tapping into the vast and underexplored potential of RNA targets, and delivering effective novel therapeutic options to patients worldwide." About ReviR Therapeutics ReviR Therapeutics is an emerging biopharmaceutical company focused on the development of RNA-targeting small molecule therapies that modulate the causal genes of diseases, including CNS diseases, cancer, and other rare genetically-defined diseases. The company is utilizing cutting-edge technologies to develop therapies with the goal of developing disease modifying therapies that are highly specific, efficacious, and safe. The company's initial focus is to apply SpliceR modulation technologies towards RNA targets of genetic diseases with limited or no treatment options. ReviR Therapeutics was founded in 2021 by leaders in computational biology, AI/ML, RNA biology, and drug discovery. The company is headquartered in Brisbane, CA. For more information, visit our website or email [email protected]. About Lapam Capital Lapam Capital is a leading healthcare venture capital firm managing six funds with more than 1.5 billion dollars under management. Lapam Capital focuses on investments in early to mid- stage fast-growing companies that have innovative pharmaceuticals and medical devices. Its investment portfolio currently consists of 120+ projects, of which innovative drug therapeutics projects account for over 80%, including Betta Pharma, RemeGen Co. Ltd., Gyre Therapeutics, Asieris Pharmaceuticals, ImmuneOnco Biopharmaceuticals, Binhui Biotech, Biostar Pharmaceuticals, Eyebright Medical Technology Ltd., and many other companies with great potential. Lapam Capital has a professional investment team with more than 20 years of international and domestic biopharmaceutical industry R&D and management experience and can provide comprehensive value-added support for the invested companies. About XtalPi Inc. XtalPi Inc. ("QuantumPharm", stock code: 2228.HK) is a quantum physics-based, AI-powered, and robotics-driven, innovative R&D platform company. Established in 2015 by three postdoctoral physicists at Massachusetts Institute of Technology (MIT), the Company is dedicated to driving intelligent and digital transformation in the life sciences and materials sciences sectors. The Company combines quantum physics, AI, cloud computing, and large-scale robotics to provide R&D solutions and services for biomedicine, chemical, renewable energy and advanced materials industries globally. About Charcot-Marie Tooth Research Foundation CMT Research Foundation (CMTRF) is a patient-led, non-profit focused on delivering treatments and cures for CMT. The foundation identifies significant obstacles or deficiencies impeding progress toward a cure and seeks out collaborators to address these issues. To date, CMTRF has funded 24 projects, of which 8 are completed. Of those 8 completed projects, 5 have clinical candidates. CMTRF's mission to invest in promising science with high potential of leading to treatments and cures was proven effective and ground-breaking when DTx Pharma with a CMTRF- backed program as its lead candidate was acquired by Novartis for $1 billion. Founded by two patients who are driven to expedite drug delivery to people who live with CMT, the 501(c)(3) federal tax-exempt organization is supported by personal and corporate financial gifts. SOURCE ReviR Therapeutics

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Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Telitacicept ( APRIL x BAFF )	Systemic Lupus Erythematosus More	Approved
Disitamab Vedotin ( HER2 x Tubulin )	HER2 Positive Transitional Cell Carcinoma More	Approved
Eflimrufusp alfa ( VEGF x bFGF )	Wet age-related macular degeneration More	Phase 3
RC-108 ( c-Met )	Gastrointestinal Neoplasms More	Phase 2
Tislelizumab ( PD-1 )	Non-Muscle Invasive Bladder Neoplasms More	Phase 2

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