A Prospective, Open-label, Multicentre, Interventional, Single-arm, Phase IV Study to Evaluate the Safety and Efficacy of Agalsidase Alfa (r-DNA Origin) (Replagal™) in Indian Children and Adults With Fabry Disease

The main aim of this study is to learn more about the safety profile of Replagal.
Participants will receive Replagal every 2 weeks at the clinic for about 1 year.

Start Date01 Nov 2022

Sponsor / Collaborator

Shire Plc

NCT04974749 / CompletedPhase 3

An Open-label Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of REPLAGAL® in Treatment-naïve Chinese Subjects With Fabry Disease

The main aim of the study is to assess the safety of REPLAGAL. Study participants will receive REPLAGAL as an intravenous infusion every other week for 52 weeks. Participants will visit their study clinic many times throughout the study.

Start Date01 May 2022

Sponsor / Collaborator

Takeda Pharmaceutical Co., Ltd.

CTR20220105 / Active, not recruitingPhase 3

一项评价瑞普佳用于治疗中国法布雷病初治受试者的安全性、疗效和药代动力学的开放标签研究

[Translation] An open-label study evaluating the safety, efficacy, and pharmacokinetics of Ripuga in treatment-naïve Chinese subjects with Fabry disease

主要目的：通过评价整个研究期间在治疗中出现的严重不良事件（TEAE）的发生率来评估瑞普佳在中国法布雷病初治受试者中的安全性。次要目的： 1.评价瑞普佳的其他安全性参数; 2.评价瑞普佳对肾功能参数（估算肾小球滤过率 [eGFR]）的疗效； 1）评价瑞普佳对其他肾功能变量、疼痛以及药效学（PD）标记物（血浆 lyso-Gb3）的疗效 2）在年龄 <18 岁的受试者中评价听力变化 3）评价瑞普佳在中国法布雷病初治受试者中的药代动力学（PK）。

[Translation]

Primary objective: To evaluate the safety of Ripuga in Chinese Fabry disease naïve subjects by evaluating the incidence of treatment-emergent serious adverse events (TEAEs) throughout the study. Secondary objectives: 1. To evaluate other safety parameters of Ripuga; 2. To evaluate the efficacy of Ripuga on renal function parameters (estimated glomerular filtration rate [eGFR]); 1) To evaluate the efficacy of Ripuga on other renal function variables, pain, and pharmacodynamic (PD) markers (plasma lyso-Gb3); 2) To evaluate hearing changes in subjects aged <18 years; 3) To evaluate the pharmacokinetics (PK) of Ripuga in Chinese Fabry disease naïve subjects.

Start Date01 May 2022

Sponsor / Collaborator

Dhl Supply Chain Netherlands BV

[+3]

100 Clinical Results associated with Agalsidase alfa

100 Translational Medicine associated with Agalsidase alfa

100 Patents (Medical) associated with Agalsidase alfa

1,143

Literatures (Medical) associated with Agalsidase alfa

01 Dec 2024·Journal of Controlled Release

Enhancing preventive and therapeutic cancer vaccine efficacy through biotherapeutic ligand-associated extracellular vesicles

Article

Author: Larssen, Pia ; Gursel, Arda ; Gursel, Ihsan ; Eldh, Maria ; Gursel, Mayda ; Guler, Ulku ; Yildirim, Tugce Canavar ; Salih, Bekir ; Horuluoglu, Begum Han ; Yagci, Fuat C ; Ayanoglu, Ihsan Cihan ; Gabrielsson, Susanne ; Akpinar, Gozde Gucluler ; Yildirim, Muzaffer ; Yazar, Volkan ; Bayyurt-Kocabas, Banu ; Evcili, Irem ; Kahraman, Tamer ; Yilmaz, Ismail C

Extracellular vesicles (EVs), secreted by almost all living cells, have gained significant attention for their role in intercellular communication and their potential as versatile carriers for biotherapeutics. However, the clinical translation of EV-based therapies faces significant challenges, primarily due to the lack of efficient methods for loading biotherapeutic agents into EVs. This study introduces a simple, reproducible strategy for the simultaneous incorporation of various biotherapeutics within EVs. The process is gentle and preserves the essential physicochemical and biological characteristics of EVs, thereby protecting labile ligands from premature degradation and elimination. The binding and uptake efficiency of EVs by target cells reached approximately 97 % within 24 h of incubation. Administration of EVs loaded with oligodeoxynucleotides (ODN) resulted in a 4-fold increase in IFNγ⁺ CD4⁺ T cells and a 5-fold increase in IFNγ⁺ CD8⁺ T cells in the spleens and lymph nodes. Additionally, the co-administration of EVs with ODN and ovalbumin (OVA) induced elevated Th1-biased antibody responses and antigen-specific cytotoxic T-cell responses, providing long-lasting complete protection in 60 % of mice against T-cell thymoma challenge. Furthermore, EVs associated with three different ligands (OVA, CpG-ODN, and α-GalCer) effectively regressed established murine melanoma and significantly improved survival rates in mice. This study presents a powerful and promising approach to overcoming the limitations of EV-based cancer vaccines, advancing the development of effective cancer immunotherapies. SUMMARY: Immunization with EVs that are co-associated with antigen and biotherapeutic cargo through a lyophilization-based technique elicits potent anti-cancer immunity.

01 Nov 2024·Redox Biology

Over-activation of iNKT cells aggravate lung injury in bronchopulmonary dysplasia mice

Article

Author: Mo, Xing-Yu ; Yi, Meng-Xu ; Zhang, Zheng ; Wang, Ming-Yan ; Su, Zhao-Liang ; Qiao, Yu ; Wei, Shan-Jie ; Lu, Hong-Yan

Bronchopulmonary dysplasia (BPD) is a severe lung disease in preterm infants, the abnormal proliferate and differentiate ability of type II epithelial cells (AEC II) is the key to the pathological basis of BPD. Mechanisms regarding abnormal AEC II in BPD remain unclear. The present work investigated the role and mechanisms of invariant natural killer T (iNKT) cells in lung disorder in BPD using public datasets, clinical samples, a hyperoxia-induced BPD mouse model and AEC II-iNKT cells transwell co-culture system. Firstly, we found that the NKT cells development factor IL-15 increased over time in patients with BPD in public databases, and clinically collected peripheral blood NKT cells in patients with BPD were increased. Subsequently, the percentage of iNKT cells increased in hyperoxia group compared with normoxia group, with the highest at P7, accompanied by increased activation with abnormal lung development. The administration of anti-CD1d neutralizing antibody to inhibit iNKT cells could alleviate the abnormal lung development of hyperoxia group mice, while α-GalCer administration could aggravate lung injury in hyperoxia group mice, and adoptive transfer of iNKT cells could aggravate the abnormal lung development in hyperoxia group mice. In addition, to further verify the role of iNKT cells on AEC II, AEC II-iNKT cells co-culture system was established. The presence of iNKT cells could aggravate the abnormal expression of SP-C and T1α under hyperoxia. Meanwhile, RNA-seq analysis showed that ferroptosis-related genes were highly expressed in AEC II co-cultured with iNKT cells under hyperoxia. We further validated the effect of the presence of iNKT cells under hyperoxia environment on AEC II ferroptosis levels, suggested that iNKT cells promote AEC II ferroptosis under hyperoxia, accompanied by decreased expression of SP-C and T1α. Our study found that the recruitment of iNKT cells in the lung may be an important cause of alveolarization disorder in BPD.

01 Oct 2024·International Journal of Biological Macromolecules

Enhancement of β-galactosidase catalytic activity and stability through covalent immobilization onto alginate/tea waste beads and evaluating its impact on the quality of some dairy products

Article

Author: Hassan, Mohamed E ; Ibrahim, Gamil E ; Abdella, Mohamed A A

The current study aimed to evaluate the hydrolysis of whole fat milk (WFM) and sweet whey (SW) using β-galactosidase (β-gal) after covalent immobilization onto activated alginate/tea waste (Alg/TW) beads as a novel carrier. The optimum temperature for free and Alg/TW/β-gal was 40 °C and the ideal pH was 7.0. However, Alg/TW/β-gal displayed better stabilities at high temperatures and a wide pH range. Additionally, the value of K_m and V_max for Alg/TW/β-gal was higher than the free enzyme. The Alg/TW/β-gal showed better residual activity (78.6 %) after 90 storage days at 4 °C. The reusability of Alg/TW/β-gal was very good as it conserved its full activity after 15 consecutive cycles and conserved 93 % of its initial activity after 10 cycles with ONPG (O-nitrophenyl-β-D-galactopyranoside) and lactose as a substrate, respectively. The impact of Alg/TW/β-gal on WFM and SW using HPLC analysis revealed a remarkable decrease in lactose concentration and increase of glucose and galactose concentrations. The SW exhibited higher degree of lactose hydrolysis (97.3 %) compared to WFM (62.4 %). Besides, SW had a prominent increase in total phenolic content (96.8 mg/L) compared to WFM (54.3 mg/L). The antioxidant activity had increased after enzyme treatment in both WFM and SW. The GC-MS analysis for volatile compounds identified twenty-five flavour constituents. Finally, Alg/TW/β-gal has a potential application for obtaining healthy, acceptable, and commercial dairy products of low lactose.

News (Medical) associated with Agalsidase alfa

12 Jul 2024

·pmlive.com

Chiesi’s rare disorder therapies approved by SMC for Fabry disease and epidermolysis bullosa

Chiesi has announced that the Scottish Medicines Consortium (SMC) has approved its two rare disease therapies, Elfabrio (pegunigalsidase alfa) and Filsuvez (birch bark extract gel), to treat Fabry disease and junctional and dystrophic epidermolysis bullosa (EB), respectively. Elfabrio has been indicated for use in adults living with the debilitating genetic disease, while Filsuvez has been approved for use in patients aged six months and older, subject to data collection under the SMC’s ultra-orphan medicines framework expected by September. Rare diseases affect around 436,000 people in Scotland and the SMC’s approval aligns with the Scottish government’s action plan for rare diseases by improving access to specialist treatments, one of the four key priorities outlined in the UK Rare Diseases Framework. The SMC’s decision on Elfabrio, a novel enzyme replacement therapy, was based on positive results from phase 3 clinical trials involving 142 Fabry disease patients, of whom 112 received Elfabrio 1mg every other week, and comes after the National Institute for Health and Care Excellence recommended the therapy in 2023. The studies showed that Elfabrio was well tolerated and was similarly clinically effective and more cost-effective compared to the current treatments being used in the NHS, agalsidase alfa and migalastat. Affecting around one in 40,000 people, Fabry disease is a rare, progressive, X-linked inherited lysosomal storage disorder that causes chronic pain and progressive damage to vital organs, including the heart, kidneys and brain. Previously approved by the European Medicines Agency, Filsuvez is a sterile gel for cutaneous application used for the treatment of partial-thickness wounds associated with dystrophic and junctional EB and is currently the only licenced therapy for this patient population. EB is a heterogenous group of rare inherited skin disorders caused by mutations in the genes that encode skin anchoring proteins of the dermo-epidermal junction and is characterised by fragile skin that is prone to blistering and erosions due to minor trauma or friction anywhere on the body. Commenting on the approvals, David Garzón Lafuente, head of rare diseases, Chiesi UK and Ireland, said: “The positive announcements for [Elfabrio] and [Filsuvez] by the SMC are a result of close collaborative working between patient organisations… to support as many people living with a rare disease as possible.”

Clinical ResultDrug ApprovalPhase 3

24 Apr 2024

·www.fiercepharma.com

Chiesi survey shows how Fabry drugs are failing patients, providing road map for ousting incumbents

Survey results speak to why Chiesi sees a need for Elfabrio. A Chiesi survey has found widespread unmet needs among Fabry disease patients taking drugs such as Sanofi’s Fabrazyme, pointing to how the Italian drugmaker can muscle in on the market. Chiesi won FDA approval for the Fabry disease drug Elfabrio last year. Patients already had access to Sanofi’s old stager Fabrazyme and Amicus Therapeutics' more recently approved oral challenger Galafold. But Chiesi identified a persistent unmet need, leading it to pay Protalix BioTherapeutics $50 million upfront plus $45 million to cover development costs to secure the rights to a Fabry prospect. Seeking to understand the unmet need, Chiesi and its collaborators surveyed 280 adults in the U.S. and Canada about their experience of living with Fabry. The researchers recently published the findings in the Orphanet Journal of Rare Diseases. Most, 84%, of the respondents were taking an enzyme replacement therapy (ERT) such as Fabrazyme or Takeda’s Replagal. Eleven percent of respondents were taking chaperone therapy, namely Galafold. Most of the people had unmet needs despite being on one of the approved treatments. The most common symptoms were low energy, tingling and pain in the hands or feet. Between 60% and 72% of respondents had those symptoms. More than half of the Fabry patients had ringing in their ears or hearing loss, general body pains or stomach pains. For 51% of respondents, the symptoms were hard to control or bothersome. Symptoms temporarily worsened between infusions in around half of respondents. However, only 48% of those patients reported the worsening to their physicians. In most cases, the doctor neither changed the patient’s treatment nor prescribed them a medicine to manage the symptoms. The survey results speak to why Chiesi sees a need for Elfabrio. Chiesi’s ERT performed similarly to Fabrazyme on the primary endpoint in a head-to-head phase 3 clinical trial. Elfabrio has a longer half-life, though, suggesting symptoms may be less likely to worsen between infusions, and its PEGylated design and other elements could improve tolerability and lower the rate of infusion-related reactions. Chiesi posted sales of 3 billion euros ($3.2 billion) in 2023, supported by 65% growth at the rare disease unit that sells Elfabrio. The statement lacks details of Elfabrio sales. Protalix generated $17.5 million from sales of Elfabrio to Chiesi last year.

Phase 3Clinical ResultDrug Approval

02 Oct 2023

·www.prnewswire.com

Global Enzyme Replacement Therapy (ERT) Markets, 2017-2022, 2022-2027F, 2032F: Lamzede's FDA Approval Paves the Way for a Brighter Future in Enzyme Replacement Therapies

DUBLIN, Oct. 2, 2023 /PRNewswire/ -- The "Enzyme Replacement Therapy Global Market Report 2023" report has been added to ResearchAndMarkets.com's offering. The global enzyme replacement therapy market is expected to grow from $10.03 billion in 2022 to $10.85 billion in 2023 at a compound annual growth rate (CAGR) of 8.1%. The market is expected to reach $14.79 billion in 2027 at a CAGR of 8.1%. In the forefront of medical advancement, the enzyme replacement therapy (ERT) market stands tall, offering vital treatment avenues for individuals grappling with chronic disorders arising from enzyme deficiencies. The research report delves deep into the nuances of the ERT sector, highlighting market statistics, regional shares, and key players commanding significant market share. ERT's pivotal role in normalizing urinary GAG levels and promoting liver and spleen health is becoming increasingly recognized. Primary enzymes like agalsidase alfa - a critical tool in the combat against Fabry's disease - are reshaping the therapeutic landscape. Our comprehensive report also categorizes other prominent enzymes used, shedding light on their applications in conditions such as Gaucher disease, Pompe disease, and more. A spotlight trend in the ERT realm is the surge in product approvals. For instance, the recent FDA nod to Lamzede (velmanase alfa) in February 2023 marked a significant milestone. As the inaugural enzyme replacement therapy greenlit in the U.S for tackling the non-central neurological manifestations of alpha-mannosidosis, Lamzede offers a promising beacon of hope. Moreover, with the escalating prevalence of rare, chronic, and genetic disorders, the ERT market trajectory looks set for robust growth. The U.S National Library of Medicine projects a near-doubling of individuals aged 50 and above with a chronic ailment by 2050, further emphasizing the critical need for effective enzyme replacement therapies. The report also touches upon the market revenues, detailing contributions from key treatments like Sebelipase alfa, Elosulfase alfa, and more. Our exhaustive coverage ensures businesses and stakeholders are well-armed with insights to navigate the dynamic ERT ecosystem. In a geographical context, while North America reigned supreme in the ERT domain in 2022, the forecasted period paints a promising picture for the Asia-Pacific region. Our study covers a broad spectrum of nations from Australia to the USA, offering a global perspective on this burgeoning market. Harness the power of data-driven insights, industry trends, and strategic opportunities with our comprehensive report, and be poised at the cusp of ERT innovations and advancements. Major players in the enzyme replacement therapy market are Biomarin Pharmaceutical Inc. Leadiant Biosciences Inc. Pfizer Inc. Sanofi S.A. AbbVie Inc. Takeda Pharmaceutical Company Limited Protalix BioTherapeutics Inc. Amicus Therapeutics Inc. Johnson & Johnson Services Inc. Digestive Care Inc. Nestle Health Science Alexion Pharmaceuticals Inc. Allergan Plc. Actelion Pharmaceuticals Ltd. CANbridge Life Sciences Ltd. Chiesi Farmaceutici S.P.A. Astrazeneca Plc. Genzyme Corporation JCR Pharmaceutical Co. Ltd. TEIJIN LIMITED Horizon Therapeutics Plc. Perseo Pharma AG SmartPharm Therapeutics Inc. Key Topics Covered: 1. Executive Summary 2. Enzyme Replacement Therapy Market Characteristics 3. Enzyme Replacement Therapy Market Trends And Strategies 4. Enzyme Replacement Therapy Market - Macro Economic Scenario 4.1. COVID-19 Impact On Enzyme Replacement Therapy Market 4.2. Ukraine-Russia War Impact On Enzyme Replacement Therapy Market 4.3. Impact Of High Inflation On Enzyme Replacement Therapy Market 5. Enzyme Replacement Therapy Market Size And Growth 5.1. Global Enzyme Replacement Therapy Historic Market, 2017-2022, $ Billion 5.1.1. Drivers Of The Market 5.1.2. Restraints On The Market 5.2. Global Enzyme Replacement Therapy Forecast Market, 2022-2027F, 2032F, $ Billion 5.2.1. Drivers Of The Market 5.2.2. Restraints On the Market 6. Enzyme Replacement Therapy Market Segmentation 6.1. Global Enzyme Replacement Therapy Market, Segmentation By Enzyme Type, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion Agalsidase Alfa Agalsidase Beta Galsulfase Other Enzyme Types 6.2. Global Enzyme Replacement Therapy Market, Segmentation By Application, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion Gaucher Disease Pompe Disease Fabry Disease Other Applications 6.3. Global Enzyme Replacement Therapy Market, Segmentation By Route Of Administration, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion Oral Parenteral 6.4. Global Enzyme Replacement Therapy Market, Segmentation By End-Users, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion Hospitals Infusion Centers Other End-Users 7. Enzyme Replacement Therapy Market Regional And Country Analysis 7.1. Global Enzyme Replacement Therapy Market, Split By Region, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion 7.2. Global Enzyme Replacement Therapy Market, Split By Country, Historic and Forecast, 2017-2022, 2022-2027F, 2032F, $ Billion For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

100 Deals associated with Agalsidase alfa

External Link

KEGG	Wiki	ATC	Drug Bank
D02784	Agalsidase alfa	A16AB03	DB15874

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Fabry Disease	IS	Takeda Pharmaceuticals International AG	03 Aug 2001
Fabry Disease	LI	Takeda Pharmaceuticals International AG	03 Aug 2001
Fabry Disease	NO	Takeda Pharmaceuticals International AG	03 Aug 2001
Fabry Disease	EU	Takeda Pharmaceuticals International AG	03 Aug 2001

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Fabry Disease	Discovery	US	Shire Plc	29 Dec 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04974749 (CTgov)	Phase 3	Fabry Disease	20	REPLAGAL	jowvaesnfx(qkkihounhh) = sykcpghcbc ejkfyluuwp (ppsdrsyvtk, gwqarkmemz - rgfhlnwipg) View more	-	08 Oct 2024
NCT04840667 (CTgov)	Phase 3	Fabry Disease	17	REPLAGAL	slruuwrvgh(qtofkgiydf) = gyvxhigxeq dbbzwvlqwu (idwioukszz, yezvkosqit - ztjkgroiwg) View more	-	17 Jun 2024
BRIDGE (SSIEM2022)	Phase 3	Fabry Disease	22	Agalsidase alfa	uslvientof(mmduvnwbue) = Seven of 20 patients (35.0%) in the efficacy population were positive for IgG anti pegunigalsidase alfa antidrug antibodies at least at 1 timepoint yfitnfxveh (smixvlxkwq ) View more	Positive	30 Aug 2022
NCT01298141 (Pubmed \| Drugs R D) Manual	Not Applicable	Fabry Disease	167	Agalsidase alfa	(efvobkzhbh) = vprsclkved usjqzajqkt (trshmgplks ) View more	Positive	01 Dec 2021
SSIEM2019	Not Applicable	Fabry Disease	493	Agalsidase alfa	xiebmmdqlo(drkhletuyy) = opfkurhthd eizkrfnpsd (kpvzrqniqo ) View more	Positive	25 Aug 2019
SSIEM2019	Not Applicable	Fabry Disease	138	agalsidase alfa	kcjgrfxwdj(vxtttrjjou) = bpspzylgfj jnbrpzsrky (meqdaxopww ) View more	-	25 Aug 2019
SSIEM2019	Not Applicable	Fabry Disease	138	agalsidase alfa	kcjgrfxwdj(vxtttrjjou) = qwqewjelqe jnbrpzsrky (meqdaxopww ) View more	-	25 Aug 2019
NCT01363492 (HGT-REP-084, Pubmed \| Drug Des Devel Ther) Manual	Phase 2	Fabry Disease	14	agalsidase alfa	(fmwgnbykyg) = bqhqvdwuea oymtxvdbmd (jjueudmjgy ) View more	Positive	25 May 2016
NCT01124643 (CTgov)	Phase 3	Fabry Disease	35	Replagal	nooijivdca(lbhmoipfif) = mcjrwkccov evarnrysua (jdajlfhzlu, jekytrciyh - ibyygajsle) View more	-	22 Aug 2014
NCT01363492 (HGT-REP-084, CTgov)	Phase 2	Fabry Disease	15	Replagal (Replagal (0.2 mg/kg))	rlmraaqhrg(rhfgalmdte) = tsjovncriy radbgdfsyi (qpsxwhxyos, xrdvngdqza - hlrnnhyaxm) View more	-	20 May 2014
NCT01363492 (HGT-REP-084, CTgov)	Phase 2	Fabry Disease	15	Replagal (Replagal 0.2 mg/kg)	qwuvzzwwjw(fqolynsaaw) = iopjadeuui uznhgcpmdv (ngekgmdmuj, veqedmmwpd - bwxkjhryfb) View more	-	20 May 2014
NCT01304277 (CTgov)	Phase 2	Fabry Disease	17	agalsidase alfa	bwslwxcpzv(jmqujshigi) = avdtkngkrv yklaooqsqb (lemtjexyvj, jawvfzpkzw - jjaszykulk) View more	-	25 Apr 2014

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