A Multicenter, Randomized, Open-Label Phase II Clinical Trial to Evaluate the Safety, Efficacy, Pharmacokinetic and Pharmacodynamic Characteristics of LP-003 Injection in Participants With Wheat Allergy

This is a multicenter, randomized, open-label Phase II clinical study to evaluate the safety, efficacy, pharmacokinetic (PK), pharmacodynamic (PD) and immunogenicity profiles of LP-003 injection in participants with Wheat dependent exercise induced anaphylaxis. Its primary objective is to explore and preliminarily evaluate the efficacy of LP-003 Injection in the participants with Wheat dependent exercise induced anaphylaxis, as well as to investigate its safety, pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.

Start Date04 Sep 2026

Sponsor / Collaborator

Longbio Pharma (Suzhou) Co., Ltd.

NCT07785063

/ Not yet recruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled Phase Ⅱ Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of LP-003 in Peanut Allergic Patients

This study will evaluate the safety and efficacy of LP-003 for an increasing the amount of peanut protein that people with a peanut allergy can tolerate without having allergic symptoms. The study will include participants 12 to 55 years of age with a confirmed peanut allergy. Participants will be randomly assigned to receive LP-003 or placebo. LP-003 will be given by an injection under the skin (subcutaneous) once every 8 weeks during the first 24 weeks of treatment. Participants will not know the treatment they are receiving until the end of the study.
The primary efficacy endpoints will be the proportion of participants in each group who successfully consume a single dose of ≥600 mg of peanut protein during a supervised double-blind, placebo-controlled food challenge at Week 24. Participants who complete the 24 weeks will continue for another 24 weeks in a blinded (participants will not know what treatment they are on) extension period, followed by a blinded follow-up period for continued safety, pharmacokinetic, pharmacodynamic, and immunogenicity assessments. The total study duration for each participant is approximately 84 weeks.

Start Date01 Sep 2026

Sponsor / Collaborator

Longbio Pharma (Suzhou) Co., Ltd.

NCT07313917

/ Not yet recruitingPhase 2

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase Ⅱ Clinical Trial to Evaluate the Efficacy and Safety of LP-003 Injection in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase II clinical trial. Its primary objective is to explore and preliminarily evaluate the efficacy and safety of LP-003 Injection in the treatment of participants with chronic rhinosinusitis with nasal polyps (CRSwNP), as well as to investigate its pharmacokinetic (PK), pharmacodynamic (PD) profiles, and immunogenicity.

Start Date20 Jan 2026

Sponsor / Collaborator

Longbio Pharma (Suzhou) Co., Ltd.

100 Clinical Results associated with LP-003 (Longbio Pharma)

100 Translational Medicine associated with LP-003 (Longbio Pharma)

100 Patents (Medical) associated with LP-003 (Longbio Pharma)

Literatures (Medical) associated with LP-003 (Longbio Pharma)

23 Jun 2026·COMBINATORIAL CHEMISTRY & HIGH THROUGHPUT SCREENING

A phase I, randomized, dose-escalation clinical trial of the anti-IgE humanized monoclonal antibody LP-003 in healthy subjects

Article

Author: Yang, Jie ; Han, Cuicui ; Zhu, Xiaoming ; Yan, Feng ; Li, Jinhong ; Liu, Heng ; Wei, Qingyu

Introduction: Immunoglobulin (Ig) E is crucial in driving inflammatory responses that lead to clinical symptoms of atopy. LP-003, a humanized Ig G1 kappa monoclonal antibody, blocks the binding of human IgE to the FcεRI receptor and was developed for the treatment of uncontrolled atopy. In this phase I trial, a randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) study was performed, and the safety, tolerability, pharmacokinetics (PK), and immunogenicity of LP-003 were assessed in healthy subjects. Methods: The study consisted of two parts: the SAD component and the MAD component. In the SAD study, five dose cohorts were planned (0.3/1.0/3.0/6.0/10.0 mg/kg). In the MAD study, two dose cohorts (2.0/4.0 mg/kg) were planned. Results: Most treatment-emergent adverse events (TEAEs) were mild or moderate, and their incidence was comparable between the LP-003 and placebo groups. The serum LP-003 concentration and PK exposures proportionally increased with dose level ranging from 0.3-10.0 mg/kg in SAD study and 2.0-4.0 mg/kg in MAD study, resulting in a prolonged serum half-life of ~70 days. The incidence of anti-drug antibodies (ADAs) was 12.5% in both SAD and MAD studies, showing no clear correlation with the dose or impact on safety. Conclusion: LP-003 demonstrated a favorable safety profile and a superior PK advantage characterized by an extended half-life, supporting its development as a long-acting therapeutic option for allergic conditions.

News (Medical) associated with LP-003 (Longbio Pharma)

05 Jun 2026

·www.prnewswire.com

China's Leading Innovative Drug Developer for Allergic and Autoimmune Diseases LongBio Pharma Lists on Hong Kong Stock Exchange

SHANGHAI, June 5, 2026 /PRNewswire/ -- LongBio Pharma, a portfolio company of Qiming Venture Partners and a leading innovative drug developer for allergic and autoimmune diseases in China, listed on the Hong Kong Stock Exchange on June 5, 2026 Beijing time, marking the seventh IPO for Qiming Venture Partners this year. LongBio Pharma (01779.HK) issued its shares at a price of HK$96.06 per share and opened at HK$144.30 per share with a market capitalization of HK$10.7 billion. Qiming Venture Partners invested in the B2 round of financing of LongBio Pharma as the lead-investor in 2024 and invested in the C round as the co-lead-investor in 2025. Before the IPO, Qiming Venture Partners held a 4.27 percent stake in LongBio Pharma as one of its major institutional investors. Founded in 2020, LongBio Pharma focuses on in-house discovery and development of biopharmaceuticals targeting on allergic and autoimmune diseases. Its founding team has rich experience in its field and has achieved outstanding results in discovery of drugs, clinical development, and registration procedures. Dr. Sun Naichao, co-founder of LongBio Pharma, is the key original inventor of omalizumab, the world's first pioneering anti-IgE antibody. He has been devoting himself to the allergic diseases for decades and is a pioneering scientist in development of drugs for allergic diseases. Dr. Liu Heng, co-founder, Chairman and CEO of the firm, has over 15 years of experience in research and development and commercialization of biopharmaceutical drugs and has played a pivotal role in both domestic and international programs of development of several innovative drugs. LongBio Pharma has developed a comprehensive product pipeline for biologic treatments targeting rhinology, dermatology, respiratory, hematology, nephrology and other autoimmune diseases. The firm's core product LP-003 is a novel anti-IgE antibody. Its main function is to block free IgE in the blood and tissues and thus inhibit the occurrence of IgE-mediated allergic reactions. According to the top-line results, LP-003 exhibited significantly better efficacy than omalizumab in the treatment of chronic spontaneous urticaria (CSU). LP-005, a major product of LongBio Pharma, is a novel bi-functional complement antibody-fusion protein targeting both C5 and C3b, has leading potential globally, and shows therapeutic potential compared with single-target complement inhibitors. "In 2024, omalizumab was approved in the United States, opening up commercialization opportunities. The prevalence of allergic diseases such as allergic rhinitis, asthma, and chronic urticaria has been rising in China. Based on clinical needs, technical barriers, team strength, and market inflection points, Qiming Venture Partners chose to invest in LongBio Pharma. The listing of LongBio Pharma is a key milestone for the company's transition from the laboratory to commercialization, and the firm is expected to grow into a leading enterprise in the field of allergic diseases in China. LongBio Pharma is also an original innovation investment made by Qiming Venture Partners during the medical capital winter, which confirms Qiming Venture Partners' resilience in navigating through industry cycles and its independent judgment ability for projects. Qiming Venture Partners will continue to focus on addressing unmet clinical needs and always pursue investments in cutting-edge medical innovation with global competitiveness," Dr. Kan Chen, a partner of Qiming Venture Partners and the co-lead of the Qiming's investments in the healthcare sector, said. About Qiming Venture Partners Qiming Venture Partners was founded in 2006. Currently, Qiming Venture Partners manages eleven US Dollar funds and seven RMB funds with $9.5 billion in capital raised. Since our establishment, we have invested in outstanding companies in the Technology and Healthcare industries at the early and growth stages. Since our debut, we have backed over 580 fast-growing and innovative companies. Over 210 of our portfolio companies have achieved exits through IPOs at the NYSE, NASDAQ, HKEX, Shanghai Stock Exchange, or Shenzhen Stock Exchange, or through M&A or other means. There are also over 80 portfolio companies that have achieved unicorn or super unicorn status. Many of our portfolio companies are today's most influential firms in their respective sectors, including Xiaomi, Meituan, Bilibili, Zhihu, Roborock, Hesai Technology, UBTech, WeRide, HyperStrong, Insta360, Unisound, Biren Technology, Z.ai, Gan & Lee Pharmaceuticals, Tigermed, Zai Lab, CanSino Biologics, Schrödinger, APT Medical, Sanyou Medical, AmoyDx, SinocellTech, Insilico Medicine, AusperBio, Yuanxin Technology, Medilink Therapeutics, LaNova Medicines, StepFun, among many others. SOURCE Qiming Venture Partners 21% more press release views with Request a Demo

Drug ApprovalIPO

02 Mar 2026

·www.prnewswire.com

Superior Efficacy and Long-acting: LongBio Announces Positive Topline Results from Phase II CSU Trial of Next-Generation Anti-IgE Therapy, LP-003 in Head-to-Head Comparison with Xolair®

PHILADELPHIA, March 2, 2026 /PRNewswire/ -- LongBio Pharma (Suzhou) Co., Ltd. ("LongBio"), a clinical-stage biotech company focused on discovery and development of biologics targeting allergic and autoimmune diseases, proudly announced positive topline results from a Phase II clinical trial of its next-generation anti-IgE antibody, LP-003, with a head-to-head comparison with Xolair® (Omalizumab). The data was presented as a late-breaking poster at the 2026 AAAAI Annual Meeting. The results demonstrated that LP-003 achieved comprehensive clinical advantages over omalizumab, with statistically superior outcomes in the key efficacy endpoints. The trial (NCT06228560, CTR20233300) is a multicenter, randomized, double-blind, placebo and active drug (Omalizumab) controlled Phase II study, designed to evaluate the efficacy and safety of LP-003 in patients with chronic spontaneous urticaria (CSU) who remain symptomatic despite antihistamine (H1) treatment. A total of 202 patients were enrolled and randomly assigned to one of three LP-003 treatment groups (100 mg Q4W, 200 mg Q4W, 200 mg Q8W), the Omalizumab group (300 mg Q4W), or the placebo group, with a total treatment duration of 24 weeks. In this head-to-head trial against Omalizumab, LP-003 exhibited comprehensive superiority in efficacy, a fast onset of action, and a favorable safety profile, further confirming its potential as a best-in-class anti-IgE therapy. LP-003 Demonstrates Comprehensive Efficacy Superiority and Fast onset Over Omalizumab For the primary endpoint, at Week 12, the proportions of patients achieving UAS7=0 were 44.4%, 66.7%, 57.5%, 43.6% and 10.8% in the LP-003 100 mg Q8W, 200 mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs. Omalizumab, p=0.0405). For the second key efficacy endpoint, LS mean changes from baseline in UAS7 at Week 12 were -23.15, -26.63, -24.74, -21.85 and -13.98 in the LP-003 100 mg Q8W, 200mg Q8W, 200 mg Q4W, Omalizumab, and placebo groups, respectively (200 mg Q8W vs. Omalizumab, p=0.0137). By Week 4, the complete remission rate across LP-003 groups reached 35%-35.9%. Compared to Omalizumab, LP-003 showed fast onset efficacy. LP-003 demonstrated statistically significant and clinically meaningful superiority compared to Omalizumab in two key efficacy endpoints, along with a favorable safety profile. The leading indication of LP-003 is seasonal allergic rhinitis (SAR), which is expected to submit Biologics License Application (BLA) to NMPA (China FDA) in or before the third quarter of 2026. Once approved, LP-003 would become the first and only innovative anti-IgE drug to be launched globally in over 20 years since the approval of Omalizumab. About LongBio LongBio is a clinical-stage biotech company. Established in 2020 and located in Shanghai and Suzhou, China, LongBio primarily focuses on the in-house discovery and development of biologics targeting on allergic and autoimmune diseases. LP-003 is an novel anti-IgE antibody developed by LongBio for the treatment of allergic diseases, including seasonal AR, CSU, allergic asthma, CRSwNP and food allergy. Compared with Xolair (Omalizumab), LP-003 has a 860-fold greater IgE binding affinity and 30-fold higher blocking activity. In addition to its potent bioactivity, LP-003 has a much longer half-life over Omalizumab. The Phase III clinical trial in China for seasonal AR indication has completed patient enrollment, with BLA submission to NMPA planned in or before Q3 2026. A Phase III trial for CSU in China is expected to start in H1 2026. For more information, please visit or contact [email protected]. SOURCE LongBio 21% more press release views with Request a Demo

Clinical ResultPhase 2Phase 3Drug Approval

12 Mar 2024

·www.prnewswire.com

Longbio Pharma Presented Positive Phase 1 Results for LP-003 at 2024AAD

SAN DIEGO, March 12, 2024 /PRNewswire/ -- Longbio Pharma (Suzhou) Co., Ltd. (referred to as "Longbio Pharma"), a leading biotech company dedicated to developing innovative protein treatments for allergy, respiratory, dermatology, hematology, ophthalmology, and other autoimmune and rare diseases, proudly announced the Phase I data of LP-003 (new generation of anti-IgE antibody) at the 2024 American Academy of Dermatology Association annual meeting (2024AAD). The presentation of the poster titled "A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody" by Longbio Pharma marked a significant moment during the conference. Title: A Phase 1 study in healthy subjects of LP-003, a novel long-acting, high affinity anti-IgE antibody Abstract Submission ID: 50484 Presentation Time: Mar 8-12, 2024 Location: Poster Exhibits Center Results: In a randomized, double-blind, single-ascending-dose Phase I clinical study (CTR20221413), 32 healthy subjects were randomly divided into 5 groups to receive a single intravenous dose of 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg and 10 mg/kg respectively. Safety, pharmacokinetics, and pharmacodynamics (free IgE levels) profile was evaluated. LP-003 exhibited a non-linear PK characteristic with T1/2 ranging from 44.6 days to 76.5 days, which is approximately 2～3 fold of Omalizumab. Moreover, the free-IgE was suppressed to below detection range for more than 168 days at 1 mg/kg group (except one with high baseline IgE level) to 10 mg/kg group. LP-003 appears to show good safety profile. No Grade 3 and above TEAE was reported, establishing a solid foundation for further investigation and advancement. Chronic spontaneous urticaria (CSU) stands as a prevalent skin disorder affecting approximately 1–2% of the global population. Despite SoC treatment, the efficacy and duration of relief remain significant challenges for patients and healthcare providers alike. Anti-IgE therapy was approved as a second-line treatment, however, only approximately 40% of patients achieving complete response following 300 mg Omalizumab dosing. Thus, a novel anti-IgE treatments offering higher efficacy and prolonged relief is needed. The successful Phase II study of Ligelizumab points a way that anti-IgE antibody with higher IgE affinity and more potent efficacy (FcεRI inhibition) retains the potential to be superior against Omalizumab. In this study, Longbio Pharma developed a new generation of anti-IgE antibody, LP-003, of higher IgE binding affinity, stronger FcεRI inhibition bioactivity, compared to Omalizumab and even Ligelizumab. Meanwhile, LP-003 has a much longer half-life (approximately 45∽76 days) compared to Omalizumab (approximately 17∽20 days). Moreover, a Phase II clinical trial (NCT06228560) of total 200 adult refractory CSU patients, despite up-dosing anti-histamine (H1) treatment, are being enrolled into 5 distinct groups (n=40/group), including three LP-003 treatment groups, one omalizumab treatment group, to provide a head-to-head comparison, and one placebo group. The topline results are expected to be released in early 2025. About LP-003 LP-003, a novel monoclonal anti-IgE antibody was generated, humanized, and engineered by Dr. Sun, Nai-chau, who is the inventor of Omalizumab, and co-founder of Tanox. Based on the 30+ years R&D experience on IgE target, Dr Sun developed a new generation of anti-IgE antibody (LP-003). Its extensive characterization including: affinity, bioactivity (FcεRI and FcεRII/CD23 inhibition), off-target binding and animal study (Tox and efficacy) was conducted. LP-003 just accomplished its Phase II study of allergic rhinitis. The current data shows LP-003 has the potential to become a best-in-class treatment. About Longbio Pharma LongBio Pharma is a biotech company located in Shanghai/Changshu, China. The company, which was founded in 2018, focuses on autoimmune and complement diseases, serving patients and society. For more information, please visit: or please contact: [email protected]. SOURCE Longbio Pharma

Phase 1Phase 2Clinical ResultAACR

100 Deals associated with LP-003 (Longbio Pharma)

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Rhinitis, Allergic, Seasonal	NDA/BLA	China	Innovent Biologics (Suzhou) Co. Ltd.	20 Aug 2026
Rhinitis, Allergic, Seasonal	NDA/BLA	China	Longbio Pharma (Suzhou) Co., Ltd.	20 Aug 2026
Wheat Hypersensitivity	Phase 2	China	Longbio Pharma (Suzhou) Co., Ltd.	02 Sep 2026
Peanut Hypersensitivity	Phase 2	-	Longbio Pharma (Suzhou) Co., Ltd.	01 Sep 2026
Chronic rhinosinusitis with nasal polyps	Phase 2	China	Longbio Pharma (Suzhou) Co., Ltd.	24 Dec 2025
Anaphylaxis	Phase 2	China	Longbio Pharma (Suzhou) Co., Ltd.	01 Oct 2025
Persistent asthma	Phase 2	China	Longbio Pharma (Suzhou) Co., Ltd.	25 Jan 2025
Allergic asthma	Phase 2	China	Longbio Pharma (Suzhou) Co., Ltd.	07 Jan 2025
Chronic Urticaria	Phase 2	China	Longbio Pharma (Suzhou) Co., Ltd.	05 Jan 2024
Aspergillosis, Allergic Bronchopulmonary	IND Approval	China	Longbio Pharma (Suzhou) Co., Ltd.	01 Apr 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06228560 (AAD2026)	Phase 2	Chronic Urticaria	202	LP-003 200 mg Q8W	fmopkxkioj(fwuaiclwvw) = zuovttqkla xwdimxahog (ucokmrqgcb )	Positive	27 Mar 2026
				LP-003 200 mg Q4W	fmopkxkioj(fwuaiclwvw) = ycnjyvtrin xwdimxahog (ucokmrqgcb )
NCT06228560 \| CTR20233300 (PRNewswire) Manual	Phase 2	Chronic Urticaria	202	LP-003 100 mg Q4W	bdwkpxfnnc(ahbyxxgkdh) = twvunhlrey cokgdyusxl (asuneawlfe ) View more	Positive	02 Mar 2026
				LP-003 200 mg Q8W	bdwkpxfnnc(ahbyxxgkdh) = lkdqrcyxcc cokgdyusxl (asuneawlfe ) View more
NCT06228560 \| CTR20233300 (NEWS) Manual	Phase 2	Chronic Urticaria	-	天辰生物LP-003	xpwhxowlsy(mvremtfuxk) = LP-003组患者瘙痒与风团症状评分（荨麻疹活动性评分UAS7）较基线降幅和实现症状完全消除（UAS7=0）的患者比例已超越奥马珠单抗组。 xdvnrhhyoz (snzgjosgup ) View more	Positive	03 Mar 2025
				奥马珠单抗
AAAAI2025	Phase 2	Chronic Urticaria	114	LP-003 100 mg Q8W	zjmaiujmsq(wdyuukwwjd) = oobuqyzliq frmqujijta (qfbmymfbgw )	Positive	28 Feb 2025
				LP-003 200 mg Q8W	zjmaiujmsq(wdyuukwwjd) = ymghitpytx frmqujijta (qfbmymfbgw )
NCT06046391 (AAAAI2024) Manual	Phase 2	Rhinitis, Allergic	180	LP-003 100mg	cewqefknbv(mnyftovxab) = azmvqdxvsj nktetwzifw (cozpiltxvc, 2.17)	Positive	25 Feb 2024
				LP-003 200mg	-

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis