Last update 19 Jun 2024

Etanercept biosimilar (Qilu Pharmaceutical)

Last update 19 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Biosimilar, Fusion protein

Synonyms

Recombinant human type II tumor necrosis factor receptor-antibody fusion protein(Qilu Pharmaceutical), 重组人II型肿瘤坏死因子受体-抗体融合蛋白（齐鲁制药）, 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（齐鲁制药）

+ [2]

Target

LTα x TNF-α

Mechanism

LTα inhibitors(Tumor necrosis factor β inhibitors), TNF-α inhibitors(Tumor necrosis factor α inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Ankylosing SpondylitisRheumatoid Arthritis

Inactive Indication-

Originator Organization

Qilu Pharmaceutical Co., Ltd.

Active Organization

Qilu Pharmaceutical Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (19 Dec 2023),

Ankylosing SpondylitisRheumatoid Arthritis

Regulation-

Gene Sequence

Sequence Code 38320

The sequence is quoted from: *****

Clinical Trials associated with Etanercept biosimilar (Qilu Pharmaceutical)

CTR20201489 / CompletedPhase 3

一项多中心、随机、双盲、平行比较QL0902与恩利在活动性类风湿关节炎患者中的有效性和安全性III期临床研究

[Translation] A multicenter, randomized, double-blind, parallel phase III clinical study comparing the efficacy and safety of QL0902 and Enbrel in patients with active rheumatoid arthritis

主要研究目的评价QL0902与恩利治疗已接受甲氨蝶呤稳定剂量治疗的活动性类风湿关节炎患者中的临床有效性是否相似。次要研究目的评价QL0902与恩利治疗已接受甲氨蝶呤稳定剂量治疗的活动性类风湿关节炎患者中的临床安全性是否相似。

[Translation]

Primary study objective To evaluate whether the clinical efficacy of QL0902 and Enbrel in patients with active rheumatoid arthritis who have received stable doses of methotrexate is similar. Secondary study objective To evaluate whether the clinical safety of QL0902 and Enbrel in patients with active rheumatoid arthritis who have received stable doses of methotrexate is similar.

Start Date04 Nov 2020

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

CTR20170508 / CompletedPhase 1

QL0902与恩利在健康志愿者中的药代动力学和安全性比对研究

[Translation] Comparative study on the pharmacokinetics and safety of QL0902 and Enbrel in healthy volunteers

主要目的：评价QL0902与恩利在男性健康志愿者单次皮下注射给药的药代动力学相似性；次要目的：评价QL0902与恩利在男性健康志愿者单次皮下注射给药的临床安全性、免疫原性的相似性。

[Translation]

Primary objective: To evaluate the pharmacokinetic similarity between QL0902 and Enbrel in healthy male volunteers after a single subcutaneous injection. Secondary objective: To evaluate the similarity in clinical safety and immunogenicity between QL0902 and Enbrel in healthy male volunteers after a single subcutaneous injection.

Start Date26 May 2017

Sponsor / Collaborator

Qilu Pharmaceutical Co., Ltd.

ChiCTR1900023437 / CompletedPhase 1IIT

A randomized, double-blind, single-dose, two-cycle, double-crossover design trial of recombinant human type II tumor necrosis factor receptor-antibody fusion protein (QL0902) for injection and the pharmacokinetics of Enli? in healthy volunteers Safety comparison study

Start Date01 Apr 2017

Sponsor / Collaborator-

100 Clinical Results associated with Etanercept biosimilar (Qilu Pharmaceutical)

100 Translational Medicine associated with Etanercept biosimilar (Qilu Pharmaceutical)

100 Patents (Medical) associated with Etanercept biosimilar (Qilu Pharmaceutical)

Literatures (Medical) associated with Etanercept biosimilar (Qilu Pharmaceutical)

01 Apr 2023·Journal of children's orthopaedics

Diagnosis and treatment of 10 cases of idiopathic chondrolysis of the hip

Article

Author: Li, Yue ; Zhao, Dun ; Fang, Bin ; Guan, Tianan ; Xiong, Hao

Objective::

To analyze the clinical characteristics, X-ray and magnetic resonance imaging manifestations, and treatment efficacy of idiopathic chondrolysis of the hip.

Methods::

Ten patients with idiopathic chondrolysis of the hip treated at our hospital from September 2013 to April 2022 were collected, and their clinical features, X-ray and magnetic resonance imaging manifestations, and treatment outcomes were analyzed.

Results::

Their main clinical features included single hip pain, claudication gait, and pelvic tilt, without specific clinical symptoms and signs. Laboratory tests such as blood analysis, erythrocyte sedimentation rate, C-reactive protein, rheumatoid factor, autoimmune test, coagulation function, interferon release test for tuberculosis infection, and tuberculosis antibody test were normal. In the late stage, the imaging shows degeneration or ankylosis of the joint. The disease progresses rapidly, and joint degeneration can occur in adolescence without effective treatment. Herein, seven patients were treated with recombinant human tumor necrosis factor receptor–antibody type II fusion protein. Among them, four (according to Camarnat magnetic resonance imaging classification, three were Stage I and one was Stage II) showed improved symptoms and function, while two (Stage III) had progressed. One patient (Stage I) who received recombinant human tumor necrosis factor receptor had no significant relief of symptoms, for whom anterior capsular release surgery significantly improved the hip joint motion. Of the four patients who underwent hip release surgery, three showed progression.

Conclusion::

Idiopathic chondrolysis of the hip has no specific clinical and laboratory tests and a high misdiagnosis rate. Thus, early magnetic resonance imaging is a critical reference for diagnosis. We recommend that patients with magnetic resonance imaging Stage II or earlier be actively treated with recombinant human tumor necrosis factor receptor and start treatment as early as possible. In the third stage, the treatment effect is mediocre, and the narrowed hip space is difficult to change.

01 Nov 2022·Clinical pharmacology in drug development

Pharmacokinetic Characteristics, Safety, and Tolerability of Telitacicept, an Injectable Recombinant Human B‐Lymphocyte Stimulating Factor Receptor‐Antibody Fusion Protein, in Healthy Chinese Subjects

Article

Author: Fan, Xiaoyun ; Ge, Qin ; Wang, Huaxue ; Chen, Xiao ; Liu, Yuanyuan ; Ma, Ling ; Xie, Jing ; Chen, Juan ; Wang, Ying ; He, Cuixia ; Zhu, Xingyu ; Zhu, Minhui ; Li, Zhijun ; Liu, Bingyan ; Zhu, Juan ; Fan, Ling ; Xie, Yunqiu ; Cao, Shugang ; Su, Yue ; Zhou, Huan

Abstract:

Telitacicept, an injectable recombinant human B‐lymphocyte stimulating factor receptor‐antibody fusion protein, is a new dual B lymphocyte stimulator (BLyS)/APRIL (a proliferation‐inducing ligand) inhibitor that effectively blocks proliferation of B lymphocytes. This study evaluates the pharmacokinetic characteristics, tolerability, and safety of a single subcutaneous injection of various doses (80, 160, and 240 mg) of telitacicept in healthy Chinese subjects. This trial is a single‐center, randomized, open‐label phase I clinical study that includes three dose groups (80, 160, and 240 mg) with 12 subjects in each dose group. The subjects were randomly assigned to different dose groups in a 1:1:1 ratio for a single subcutaneous administration trial. After a single dose, the maximum serum concentration (Cmax) of total and free telitacicept was reached within 0.5‐1 days. The elimination half‐lives of total and free telitacicept at doses of 80–240 mg were 10.9–11.9 days and 11–12.5 days, respectively. The formation and elimination of the BLyS‐telitacicept complex were much slower; the median time to Cmax was 15–57 days and was significantly prolonged with increasing dose. Only two of the 36 healthy subjects had positive antidrug antibodies with antibody titers of 1:15. The severity of adverse events was mild or moderate, and no higher treatment‐emergent adverse events were reported. In conclusion, total telitacicept within a dose range of 80–240 mg and free telitacicept within a dose range of 160–240 mg had linear pharmacokinetic characteristics.

12 Sep 2022·Zhongguo zhen jiu = Chinese acupuncture & moxibustion

[Effect on ankylosing spondylitis at early-middle stage and bone marrow edema of sacroiliac joint treated with acupuncture and governor vessel moxibustion].

Article

Author: Zhang, Xue ; Chen, Qing-Wei ; Bu, He ; Lv, Hong-Yan ; Yan, Hui-Ming ; Wang, Zi-Xuan ; Ma, Yao

OBJECTIVE:

To observe the efficacy of the combined treatment with acupuncture and governor vessel moxibustion on ankylosing spondylitis (AS) at early-middle stage and investigate the effect on bone marrow edema of sacroiliac joint.

METHODS:

Seventy patients of AS at early-middle stage were randomized into an observation group (35 cases) and a control group (35 cases, 1 case dropped off ). In the control group, the recombinant human tumor necrosis factor receptor-antibody of type Ⅱ fusion protein for injection was injected subcutaneously, 25 mg each time, once on every Monday and Friday, consecutively for 3 weeks. In the observation group, on the base of the intervention as the control group, acupuncture combined with governor vessel moxibustion were provided. Acupuncture was applied to Dazhui (GV 14), Changqiang (GV 1), Zhibian (BL 54), Baihui (GV 20), etc.; the thermal needling technique was adopted at Dazhui (GV 4) and Changqiang (GV 1) for promoting the circulation of the governor vessel, and the ginger-isolated moxibustion on the governor vessel was combined. Such intervention measure was provided once daily. One treatment session contained 7 treatments and 3 sessions were required. Before and after treatment, the scores of Spondyloarthritis Research Consortium of Canada (SPARCC), Bath ankylosing spondylitis disease activity index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) and Bath ankylosing spondylitis patient global score (BAS-G) were observed in the two groups separately. The efficacy and adverse effects were assessed in the two groups after treatment.

RESULTS:

The scores of SPARCC, BASDAI, BASFI and BAS-G were all reduced after treatment compared with those before treatment in the two groups (P<0.05), and those in the observation group were lower than the control group (P<0.05). The total effective rate was 97.1% (34/35) in the observation group, higher than 82.4% (28/34) in the control group (P<0.05). There were 4 cases of gastrointestinal reactions and 1 case of skin rashes in the control group; and 3 cases of local skin redness and pruritus after governor vessel moxibustion, no any drug adverse effect was found in the observation group.

CONCLUSION:

Based on the western medicine treatment, the combined therapy of acupuncture and governor vessel moxibustion may relieve bone marrow edema of sacroiliac joint in patients with AS at early-middle stage, control the progression of disease and improve the daily life activity. This therapy is relatively safe and effective.

News (Medical) associated with Etanercept biosimilar (Qilu Pharmaceutical)

12 Jun 2024

·www.prnewswire.com

Nektar Therapeutics Presents First Preclinical Data on NKTR-0165, a TNFR2 Agonist Antibody Being Developed for the Treatment of Inflammatory Diseases, at EULAR 2024

– NKTR-0165 Demonstrates Selective Enhancement of Treg Cell Function Through Novel Agonistic Mechanism – – IND-Enabling Studies Underway for NKTR-0165 with First-in-Human Studies Planned in First Half of 2025 - SAN FRANCISCO, June 12, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced the presentation of a poster highlighting new preclinical data on NKTR-0165 at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress. NKTR-0165 is a novel, first-in-class tumor necrosis factor receptor 2 (TNFR2) agonist and bivalent antibody designed to selectively stimulate TNFR2 receptor activity, without modulation of the TNFR1 signaling. TNFR2 signaling has been shown to be an important gatekeeper of inflammation and its absence or deficit is associated with a broad range of autoimmune diseases. TNFR2 is highly expressed on Tregs, neuronal cells and endothelial cells and has been shown to potentiate the suppressive effects and overall functional properties of regulatory T cells (Tregs). "The preclinical data presented at EULAR show that NKTR-0165 is a unique antibody that selectively binds to TNFR2 on Tregs to enhance its immunosuppressive activities, and could potentially become a first-in-class treatment for various autoimmune diseases, including ulcerative colitis and vitiligo," said Jonathan Zalevsky, Ph.D., Senior Vice President and Chief Research & Development Officer at Nektar. "By selectively binding to TNFR2, NKTR-0165 upregulates expression of proteins that are critical to Treg proliferation and function. Animal models show that NKTR-0165 reduces inflammation through the selective enhancement of Treg cell function via TNFR2 agonism. These data demonstrate a unique and differentiated profile for this bivalent antibody in the field of TNFR2 agonists." The poster presentation is available for download at . Key details and takeaways from the presentation are as follows: Abstract 3174: "A Novel Therapeutically Active Anti-TNFR2 Agonistic Antibody Promotes Treg Proliferation and Induction of Treg Functional Markers", Miyazaki, et al. NKTR-0165 shows selective TNFR2 binding and receptor agonism in human Tregs, with minimal binding and signaling activity in other TNFR2-expressing immune cells in vitro and in vivo. NKTR-0165 agonistic activity enhances Treg lineage stabilization and upregulates expression of proteins involved in Treg proliferation and function. NKTR-0165 demonstrates therapeutic efficacy in a KLH-induced delayed type hypersensitivity (DTH) model in human TNFR2 knock-in mice. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Our pipeline also includes a preclinical candidate NKTR-0165, which is a bivalent tumor necrosis factor receptor type II agonist antibody. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "could," "design," "develop," "potential" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-0165 and rezpegaldesleukin, observations from early data emerging from preclinical research of NKTR-0165, the potential of the technology incorporated into our drug candidates, and the future development plans for NKTR-0165 and rezpegaldesleukin. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of NKTR-0165 and rezpegaldesleukin are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) NKTR-0165 and rezpegaldesleukin are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin is in clinical development and NTKR-0165 is in preclinical development, and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challenges caused by health epidemics, regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) we may not achieve the expected cost savings we expect from our 2022 corporate restructuring and reorganization plan or our 2023 cost restructuring plan and we may undertake additional restructuring and cost-saving activities in the future, (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2024. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contact: For Investors: Vivian Wu of Nektar Therapeutics 628-895-0661 For Media: David Rosen of Argot Partners (212) 600-1902 [email protected] SOURCE Nektar Therapeutics

Phase 2AACRImmunotherapy

30 May 2024

·www.prnewswire.com

Nektar Management to Present at Upcoming Investor Conferences

SAN FRANCISCO, May 30, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) management is scheduled to present at upcoming investor conferences: Jefferies Healthcare Conference in New York City on Thursday, June 6, 2024 at 3:30 p.m. Eastern Time / 12:30 p.m. Pacific Time Goldman Sachs 45th Annual Global Healthcare Conference in Miami on Monday, June 10, 2024 at 2:00 p.m. Eastern Time / 11:00 a.m. Pacific Time The presentations will be accessible via webcast through links posted on the Investor Events section of the Nektar website: . The webcasts will be available for replay until July 6, 2024 and July 10, 2024, respectively. About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Our pipeline also includes a preclinical candidate NKTR-0165, which is a bivalent tumor necrosis factor receptor type II agonist antibody. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow us on LinkedIn. Contact: For Investors: Vivian Wu of Nektar Therapeutics 628-895-0661 For Media: David Rosen of Argot Partners (212) 600-1902 [email protected] SOURCE Nektar Therapeutics

Phase 2

09 May 2024

·www.prnewswire.com

Nektar Therapeutics Reports First Quarter 2024 Financial Results

SAN FRANCISCO, May 9, 2024 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today reported financial results for the first quarter ended March 31, 2024. Cash and investments in marketable securities at March 31, 2024 were $326.0 million as compared to $329.4 million at December 31, 2023. Nektar's cash and marketable securities are expected to support strategic development activities and operations into the third quarter of 2026. "In the first quarter, we made significant progress with our highly promising immunology and inflammation pipeline," said Howard W. Robin, President and CEO of Nektar. "REZPEG is advancing in the clinic in our Phase 2b study in patients with atopic dermatitis and in our Phase 2b study in patients with alopecia areata. Enrollment for both studies is on-track, and we expect to report topline data from these trials in the first half of 2025. Building out our Treg pipeline, our novel bivalent antibody targeting the TNFR2 receptor is progressing through IND-enabling studies to support entering the clinic next year." Summary of Financial Results Revenue in the first quarter of 2024 was $21.6 million as compared to the same $21.6 million in the first quarter of 2023. Total operating costs and expenses in the first quarter of 2024 were $57.1 million as compared to $156.3 million in the first quarter of 2023. Operating costs and expenses for the first quarter of 2023 included a one-time $76.5 million non-cash goodwill impairment charge. Operating costs and expenses for the first quarter of 2024 further decreased as compared to 2023 due to decreases in restructuring, impairment and costs of terminated program, as well as decreases in R&D and G&A expense. R&D expense in the first quarter of 2024 was $27.4 million as compared to $30.5 million for the first quarter of 2023. R&D expense for the first quarter of 2024 decreased primarily due to a decrease in employee costs and related facilities costs, partially offset by an increase in expense for the development of rezpegaldesleukin and NKTR-0165, our TNFR2 agonist antibody. G&A expense was $20.1 million in the first quarter of 2024 as compared to $21.1 million in the first quarter of 2023. Restructuring, impairment and other costs of the terminated program were $1.0 million in the first quarter of 2024 as compared to $21.2 million in the first quarter of 2023. Restructuring, impairment and other costs of terminated program decreased primarily due to $13.2 million in non-cash lease and equipment impairment charges and $5.5 million in severance expense recognized in the first quarter of 2023. Net loss for the first quarter of 2024 was $36.8 million or $0.19 basic and diluted loss per share as compared to a net loss of $137.0 million or $0.73 basic and diluted loss per share in the first quarter of 2023. First Quarter 2024 and Recent Business Highlights In March 2024, Nektar initiated a Phase 2b study of rezpegaldesleukin in patients with severe to very severe alopecia areata. The Company expects topline data from this study in the first half of 2025. Enrollment is ongoing in the Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis. The Company expects topline data from the study in the first half of 2025. In March 2024, we entered into a securities purchase agreement with TCG Crossover Fund, an institutional accredited investor, to sell securities in a private placement financing for gross proceeds to the Company of approximately $30 million, before deducting expenses. Conference Call to Discuss First Quarter 2024 Financial Results Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time, May 9, 2024. This press release and live audio-only webcast of the conference call can be accessed through a link that is posted on the Home Page and Investors section of the Nektar website: . The web broadcast of the conference call will be available for replay through June 9, 2024. To access the conference call, follow these instructions: Dial: (800) 715-9871 (U.S & Canada) Conference ID: 4855448 About Nektar Therapeutics Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments that address the underlying immunological dysfunction in autoimmune and chronic inflammatory diseases. Nektar's lead product candidate, rezpegaldesleukin (REZPEG, or NKTR-358), is a novel, first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials, one in atopic dermatitis and one in alopecia areata. Our pipeline also includes a preclinical candidate NKTR-0165, which is a bivalent tumor necrosis factor receptor type II agonist antibody. Nektar, together with various partners, is also evaluating NKTR-255, an investigational IL-15 receptor agonist designed to boost the immune system's natural ability to fight cancer, in several ongoing clinical trials. Nektar is headquartered in San Francisco, California. For further information, visit and follow us on LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements which can be identified by words such as: "will," "expect," "develop," "potential," "advance," "anticipate," and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding the therapeutic potential of, and future development plans for, rezpegaldesleukin and NKTR-0165. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of rezpegaldesleukin and NKTR-0165 are based on preclinical and clinical findings and observations and are subject to change as research and development continue; (ii) rezpegaldesleukin and NKTR-0165 are investigational agents and continued research and development for these drug candidates is subject to substantial risks, including negative safety and efficacy findings in future clinical studies (notwithstanding positive findings in earlier preclinical and clinical studies); (iii) rezpegaldesleukin is in clinical development and NTKR-0165 is in preclinical development, and the risk of failure is high and can unexpectedly occur at any stage prior to regulatory approval; (iv) the timing of the commencement or end of clinical trials and the availability of clinical data may be delayed or unsuccessful due to challenges caused by health epidemics, including the recent COVID-19 pandemic, regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (v) we may not achieve the expected cost savings we expect from our 2022 corporate restructuring and reorganization plan or our 2023 cost restructuring plan and we may undertake additional restructuring and cost-saving activities in the future, (vi) patents may not issue from our patent applications for our drug candidates, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vii) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-K filed with the Securities and Exchange Commission on March 5, 2024. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Contact: For Investors: Vivian Wu of Nektar Therapeutics 628-895-0661 For Media: David Rosen of Argot Partners (212) 600-1902 [email protected] SOURCE Nektar Therapeutics

Phase 2Financial StatementPhase 1

100 Deals associated with Etanercept biosimilar (Qilu Pharmaceutical)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB01	DB00005

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Ankylosing Spondylitis	CN	Qilu Pharmaceutical Co., Ltd.	19 Dec 2023
Rheumatoid Arthritis	CN	Qilu Pharmaceutical Co., Ltd.	19 Dec 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ChiCTR1900023437 (Pubmed \| Expert Opin Biol Ther)	Phase 1	-	68	QL0902	jyirifvrfk(ljrhhkccbf) = bvalikqfqe wwbpacungs (gxhzzunkrv ) View more	-	21 Mar 2020
				Reference Etanercept	jyirifvrfk(ljrhhkccbf) = jbzyzaccza wwbpacungs (gxhzzunkrv ) View more

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