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更新于：2026-06-02
L-9LS
更新于：2026-06-02
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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关联
9
项与 L-9LS 相关的临床试验NCT07208760
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of L9LS on R21/Matrix-M™ Vaccine Immunogenicity
This is a randomized, double-blind, placebo-controlled trial in 2 parts evaluating the effect of 1-time administration of the monoclonal antibody (MAb) L9LS to healthy Malian participants on the immunogenicity of subsequent administration of the R21/Matrix-M™ vaccine. L9LS will be administered subcutaneously (SC) for adults and infants. The study will assess how the timing of L9LS administration impacts immunogenicity following subsequent intramuscular (IM) R21/Matrix-M™ vaccination. Twenty-four adult participants and 333 infant participants will be enrolled.
开始日期2026-03-01 |
NCT07060508
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali
开始日期2025-07-22 |
PACTR202410517100221
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Efficacy of the Anti-Malaria Monoclonal Antibody L9LS in Infants 10 Weeks of Age in Western Kenya and to Evaluate the Impact of L9LS on Subsequent Malaria Vaccine Immunogenicity
开始日期2024-12-02 |
申办/合作机构- |
100 项与 L-9LS 相关的临床结果
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100 项与 L-9LS 相关的转化医学
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100 项与 L-9LS 相关的专利（医药）
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3
项与 L-9LS 相关的文献（医药）2026-04-01·LANCET
Safety and efficacy of the monoclonal antibody L9LS for malaria prevention in children exposed to perennial malaria transmission in Kenya: a randomised, double-blind, placebo-controlled, phase 2 trial
Article
BACKGROUND:
Malaria remains a major cause of mortality globally, especially among young children in sub-Saharan Africa. The long-acting monoclonal antibody L9LS has shown high efficacy in preventing malaria in children aged 6-10 years exposed to seasonal transmission but remains untested in perennial transmission settings and younger children. We assessed the safety, tolerability, and efficacy of L9LS in infants and children in a high perennial malaria transmission setting.
METHODS:
This double-blind, two-part, randomised, placebo-controlled, phase 2 trial was done in Siaya county in western Kenya. In parts 1a and 1b, we tested the safety and tolerability of L9LS using an age de-escalation and dose escalation approach and randomly assigned (3:1) cohorts of healthy children (three cohorts aged 5-10 years, three cohorts aged 5-59 months, and two cohorts aged 5-71 months) to L9LS at doses of 5, 10, 20, 30, or 40 mg/kg subcutaneously or to placebo (normal saline). In part 2, healthy children aged 5-59 months were randomly assigned (1:1:1) by use of centralised computer-generated lists to receive two doses of L9LS at 10-20 mg/kg at baseline and month 6, one dose of L9LS at baseline and placebo at month 6, or placebo at both timepoints. Children were followed up for 12 months with monthly clinic visits and blood smear collections. Primary safety outcomes were incidence and severity of local and systemic solicited adverse events within 7 days of dosing and serious adverse events throughout follow-up. The primary efficacy endpoint was Plasmodium falciparum infection detected by blood smear over 12 months. Primary analyses were done in the modified intention-to-treat population, consisting of all randomly assigned participants who received the study intervention. This trial is registered with ClinicalTrials.gov (NCT05400655) and is complete.
FINDINGS:
In parts 1a and 1b, 96 children were enrolled and randomly assigned between Oct 1, 2022, and Jan 16, 2024; 72 participants were assigned to L9LS and 24 were assigned to placebo. In part 2, 324 children aged 5-59 months were enrolled and randomly assigned between Jan 26 and June 2, 2023; 108 children were assigned to one-dose L9LS, 106 to two-dose L9LS, and 110 to placebo. Across all study parts, grade 3 or worse treatment-related adverse events occurred after four (1%) of 384 L9LS injections and two (1%) of 338 placebo injections; these events all resolved by study end. The proportion of solicited and unsolicited adverse events was similar across all L9LS dose groups. There were no serious adverse events related to the trial. In part 2, 70 (66%) of 106 children in the two-dose L9LS group had at least one P falciparum infection during the 12-month follow-up versus 91 (83%) of 110 children in the placebo group (protective efficacy 42·7%, 95% CI 22·5-57·7; p=0·0003).
INTERPRETATION:
L9LS was protective against malaria in young children in western Kenya without evident safety concerns over 6-12 months. A higher dose of L9LS might be needed to achieve high-level efficacy against malaria in young children exposed to intense perennial P falciparum transmission.
FUNDING:
Gates Foundation.
2025-04-23·Science Translational Medicine
FcγR binding differentially contributes to protection by two human monoclonal antibodies targeting
Plasmodium falciparum
circumsporozoite protein
Article
作者: Chakraborty, Saborni ; Wang, Taia T. ; Alter, Galit ; Pierson, Theodore C. ; Seder, Robert A. ; Asokan, Mangaiarkarasi ; Kiyuka, Patience ; Flynn, Barbara ; Ogwang, Rodney ; Zur, Yonatan ; Dillon, Marlon ; Flores-Garcia, Yevel ; Koup, Richard A. ; Ernste, Keenan ; MacVicar, Ryan ; Herman, Jonathan D. ; Liu, Cuiping ; Idris, Azza H. ; Zavala, Fidel ; Silva Pereira, Lais D. ; DeMouth, Megan E. ; Bonilla, Brian ; Francica, Joseph ; Kisalu, Neville K. ; Nikolaeva, Daria ; Lofgren, Mariah ; Pegu, Amarendra ; Merriam, Jonah
Antibodies mediate protection against a wide range of pathogens through binding and neutralizing the pathogen or through Fc-mediated effector functions. Human monoclonal antibodies (mAbs) CIS43LS and L9LS show high-affinity binding targeting distinct regions on the
Plasmodium falciparum
circumsporozoite protein (PfCSP) and are highly effective in preventing malaria in humans. However, the role of FcγR binding in protection by these mAbs has not been determined. Here, we assessed several Fc variants of CIS43LS and L9LS for protection against infection with transgenic
Plasmodium berghei
parasite expressing PfCSP in mice. Limiting binding to FcγRs did not reduce protection compared to the parental mAbs in mice. To determine whether protection could be improved in vivo by Fc modification, we engineered Fc variant mAbs with increased binding to distinct FcγRs. Passive transfer of CIS43LS-DE and CIS43LS-DEAL variants resulted in an approximately two- to threefold reduction in the liver-stage parasite burden in C57BL/6 or human FcγR mice compared with the parental CIS43LS after challenge. CIS43LS-DEAL also enhanced protection of mice after mosquito bite challenge. Systems serology analysis revealed that the CIS43LS-DE and CIS43LS-DEAL variants could enhance human neutrophil and monocyte phagocytosis, as well as NK cell activation, compared with CIS43LS. However, similar Fc modifications incorporated into L9LS did not increase protection compared to the parental mAb. Overall, although FcγR binding by CIS43LS and L9LS is dispensable in mouse models of malaria, enhancing the binding of CIS43LS to FcγR showed a modest increase in the potency of this mAb.
2024-05-02·The New England journal of medicine
Subcutaneous Administration of a Monoclonal Antibody to Prevent Malaria
Article
作者: Traore, Hamadi ; McDermott, Adrian B ; Narpala, Sandeep ; Reiber, Matthew ; Portugal, Silvia ; Lin, Bob C ; Keita, Mamadou ; Peterson, Mary E ; Idris, Azza H ; Carlton, Kevin ; Traore, Siriman ; Hickman, Somia P ; Hu, Zonghui ; Doumbo, Safiatou ; McDougal, Andrew J ; Stein, Judy A ; Ouattara, Adama ; Seder, Robert A ; Zéguimé, Amatigué ; Wang, Jing ; Ongoiba, Aissata ; Murphy, Sean C ; Doucoure, M'Bouye ; Schwabl, Philipp ; Serebryannyy, Leonid ; Djimdé, Abdoulaye ; Li, Shanping ; Kayentao, Kassoum ; Djiguiba, Adama ; Neafsey, Daniel E ; Dolo, Amagana ; Crompton, Peter D ; Cisse, Hamidou ; Vazquez, Sandra ; Healy, Sara A ; Traore, Boubacar ; Traore, Abdrahamane ; Skinner, Jeff ; Telscher, Shinyi ; Preston, Anne C ; Doumtabe, Didier ; Gall, Jason G ; Adams, William C
BACKGROUND:
Subcutaneous administration of the monoclonal antibody L9LS protected adults against controlled Plasmodium falciparum infection in a phase 1 trial. Whether a monoclonal antibody administered subcutaneously can protect children from P. falciparum infection in a region where this organism is endemic is unclear.
METHODS:
We conducted a phase 2 trial in Mali to assess the safety and efficacy of subcutaneous administration of L9LS in children 6 to 10 years of age over a 6-month malaria season. In part A of the trial, safety was assessed at three dose levels in adults, followed by assessment at two dose levels in children. In part B of the trial, children were randomly assigned, in a 1:1:1 ratio, to receive 150 mg of L9LS, 300 mg of L9LS, or placebo. The primary efficacy end point, assessed in a time-to-event analysis, was the first P. falciparum infection, as detected on blood smear performed at least every 2 weeks for 24 weeks. A secondary efficacy end point was the first episode of clinical malaria, as assessed in a time-to-event analysis.
RESULTS:
No safety concerns were identified in the dose-escalation part of the trial (part A). In part B, 225 children underwent randomization, with 75 children assigned to each group. No safety concerns were identified in part B. P. falciparum infection occurred in 36 participants (48%) in the 150-mg group, in 30 (40%) in the 300-mg group, and in 61 (81%) in the placebo group. The efficacy of L9LS against P. falciparum infection, as compared with placebo, was 66% (adjusted confidence interval [95% CI], 45 to 79) with the 150-mg dose and 70% (adjusted 95% CI, 50 to 82) with the 300-mg dose (P<0.001 for both comparisons). Efficacy against clinical malaria was 67% (adjusted 95% CI, 39 to 82) with the 150-mg dose and 77% (adjusted 95% CI, 55 to 89) with the 300-mg dose (P<0.001 for both comparisons).
CONCLUSIONS:
Subcutaneous administration of L9LS to children was protective against P. falciparum infection and clinical malaria over a period of 6 months. (Funded by the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT05304611.).
4
项与 L-9LS 相关的新闻（医药）2024-05-09
PASADENA, Calif.--(BUSINESS WIRE)-- Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of cancer and other serious diseases, today reported financial results for the first quarter ended March 31, 2024 and provided a review of recent clinical and business highlights.
“We have focused our XmAb® clinical pipeline and discovery activities on bispecific CD3 and CD28 T cell engagers, which continue to show clinical validation for their potential in treating patients with serious diseases. Our key clinical-stage oncology programs in solid tumors include XmAb819 (ENPP3 x CD3) in clear cell renal cell carcinoma, XmAb808 (B7-H3 x CD28) in prostate cancer and other cancers, and XmAb541 (CLDN6 x CD3) in ovarian cancer and other cancers, which are all now advancing in Phase 1 clinical studies. We plan to select our next T cell engager IND candidate later this year,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “Additionally, Xencor’s best-in-class Xtend™ antibody half-life extension technology continues to support improved outcomes for patients, with Ultomiris® now approved in the U.S. for certain patients with NMOSD, and we are especially delighted by recently published results demonstrating an investigational antibody with Xtend was effective in preventing malaria.”
Recent Clinical and Business Highlights
First Patient Dosed in Phase 1 Study of XmAb®541 (CLDN6 x CD3): XmAb541 is a bispecific antibody being developed for patients with CLDN6-positive tumors including advanced ovarian cancer. XmAb541 is designed to engage the immune system, activating T cells for highly potent and targeted killing of tumor cells expressing Claudin-6 (CLDN6), a tumor-associated antigen. Xencor’s XmAb® 2+1 multivalent format used in XmAb541 enables greater selectivity for cells expressing CLDN6 over similarly structured Claudin family members, which may be expressed on normal tissue. The first patient was recently dosed in a Phase 1 dose-escalation study.
FDA Approves Ultomiris® (Alexion Pharmaceuticals, Inc.) for Adults with NMOSD: In March 2024, Ultomiris® (ravulizumab-cwvz), which incorporates Xencor’s Xtend™ Fc Domain, was approved in the United States as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). Ultomiris is also approved for certain adults with NMOSD in Japan and the European Union (EU). As part of Xencor’s recent Ultomiris royalty monetization, the Company remains eligible for certain future royalties and milestone payments. Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.
Single Dose of Investigational Antibody with Xtend™ Confers Protection Against Malaria Infection: Results from a Phase 2 National Institutes of Health (NIH)-sponsored clinical trial published in the New England Journal of Medicine showed that a single dose of L9LS, an experimental monoclonal antibody that incorporates Xencor’s Xtend™ Fc Domain, was up to 77% effective in preventing malaria in children in Mali for six months, demonstrating the long duration of action that Xtend technology can provide.
New Chief Financial Officer Appointed: Bart Cornelissen was appointed as Xencor’s senior vice president and chief financial officer. He was most recently vice president, corporate finance at Seagen Inc.
Financial Guidance: Based on current operating plans, Xencor expects to end 2024 with between $475 million and $525 million in cash, cash equivalents and marketable debt securities, and to have cash to fund research and development programs and operations into 2027.
Financial Results for the First Quarter Ended March 31, 2024
Cash, cash equivalents and marketable debt securities totaled $646.7 million as of March 31, 2024, compared to $697.4 million on December 31, 2023.
Revenues for the first quarter ended March 31, 2024 were $12.8 million, compared to $19.0 million for the same period in 2023. Total revenues earned in the first quarter of 2024 included non-cash royalty revenue from Xencor’s Alexion and Morphosys/Incyte agreements, compared to milestone revenue earned from the J&J collaboration and royalties from the Alexion agreement in the first quarter of 2023.
Research and development expenses for the first quarter ended March 31, 2024 were $56.9 million, compared to $65.6 million for the same period in 2023. Decreased research and development spending for the first quarter of 2024 compared to 2023 reflects changes in spending across multiple clinical-stage programs and wind-down costs on terminated programs.
General and administrative expenses for the first quarter ended March 31, 2024 were $13.8 million and were in line with $14.2 million for the same period in 2023.
Other expense, net, for the first quarter ended March 31, 2024 was $10.8 million, compared to $0.02 million for the same period in 2023. Increased other expense for the first quarter of 2024 compared to 2023 reflects impairment charge on equity investments, partially offset by interest income earned on investments and unrealized gain on equity investments.
Non-cash, stock-based compensation expense for the first quarter ended March 31, 2024 was $11.4 million, compared to $12.6 million for the same period in 2023.
Net loss for the first quarter ended March 31, 2024 was $68.0 million, or $(1.11) on a fully diluted per share basis, compared to $60.8 million, or $(1.02) on a fully diluted per share basis, for the same period in 2023.
The total shares outstanding were 61,634,685 as of March 31, 2024, compared to 60,381,600 as of March 31, 2023.
Upcoming Investor Conferences
Company management will participate at multiple upcoming investor conferences:
RBC Capital Markets Global Healthcare Conference
Date: Tuesday, May 14, 2024
Presentation Time: 2:05 p.m. ET / 11:05 a.m. PT
Location: New York City
BofA Securities Health Care Conference
Date: Wednesday, May 15, 2024
Presentation Time: 4:40 p.m. ET / 1:40 p.m. PT
Location: Las Vegas
Live webcasts of the presentations will be available under “Events & Presentations” in the Investors section of the Company’s website located at . Replays of the events will be available on the Xencor website for at least 30 days following the presentations.
About Xencor
Xencor is a clinical-stage biopharmaceutical company developing engineered antibodies for the treatment of patients with cancer and other serious diseases. More than 20 candidates engineered with Xencor's XmAb® technology are in clinical development, and three XmAb medicines are marketed by partners. Xencor's XmAb engineering technology enables small changes to a proteins structure that result in new mechanisms of therapeutic action. For more information, please visit .
Forward-Looking Statements
Certain statements contained in this press release may constitute forward-looking statements within the meaning of applicable securities laws. Forward-looking statements include statements that are not purely statements of historical fact, and can generally be identified by the use of words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” and similar terms, or by express or implied discussions relating to Xencor’s business, including, but not limited to, statements regarding planned presentations of clinical data, planned clinical trials, projected financial resources, the quotations from Xencor's president and chief executive officer, and other statements that are not purely statements of historical fact. Such statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Xencor and are subject to significant known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks, including the ability of publicly disclosed preliminary clinical trial data to support continued clinical development and regulatory approval for specific treatments, in each case as described in Xencor's public securities filings. For a discussion of these and other factors, please refer to Xencor's annual report on Form 10-K for the year ended December 31, 2023 as well as Xencor's subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended to date. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
Xencor, Inc.
Selected Consolidated Balance Sheet Data
(in thousands)
March 31,
December 31,
2024
2023
(Unaudited)
Cash, cash equivalents and marketable debt securities - current
$
491,401
$
551,515
Other current assets
70,851
71,645
Marketable debt securities - long term
155,342
145,892
Other long term assets
166,661
183,640
Total assets
$
884,255
$
952,692
Total current liabilities
79,402
84,709
Deferred income - long term
113,367
125,183
Other long term liabilities
79,299
73,667
Total liabilities
272,068
283,559
Total stockholders' equity
612,187
669,133
Total liabilities and stockholders’ equity
$
884,255
$
952,692
Xencor, Inc.
Consolidated Statements of Loss and Comprehensive Loss
(in thousands, except share and per share data)
Three months Ended March 31,
2024
2023
(Unaudited)
Revenue
$
12,805
$
18,962
Operating expenses
Research and development
56,873
65,552
General and administrative
13,787
14,154
Total operating expenses
70,660
79,706
Loss from operations
(57,855
)
(60,744
)
Other income (expense), net
(10,854
)
(19
)
Loss before income tax
(68,709
)
(60,763
)
Income tax expense
—
—
Net loss
(68,709
)
(60,763
)
Net loss attributable to non-controlling interest
(676
)
—
Net loss attributable to Xencor, Inc.
(68,033
)
(60,763
)
Other comprehensive income (loss):
Net unrealized gain (loss) on marketable debt securities available-for-sale
(1,445
)
3,327
Comprehensive loss attributable to Xencor, Inc.
$
(69,478
)
$
(57,436
)
Net loss per common share attributable to Xencor, Inc.:
Basic and Diluted
$
(1.11
)
$
(1.02
)
Weighted average common shares used to compute net loss per share attributable to Xencor, Inc.
Basic and Diluted
61,212,324
59,771,674
临床1期临床2期上市批准临床结果财报
2023-01-29
点击上方的 行舟Drug ▲ 添加关注中国创新型生物制品注册分类的研究与思考来源《中国新药杂志》2022年第31卷第24期作者过其祥，杨景舒，杨悦清华大学药学院国家药品监督管理局创新药物研究与评价重点实验室摘要基于全球出现的一系列创新型生物制品注册分类与产品实际用途不匹配的问题，如预防用单克隆抗体和治疗用疫苗，本文对国内外生物制品的分类和注册申请路径进行比较，分析如何与时俱进地调整注册分类方法，为创新生物制品的研发注册提供适宜的监管路径和程序。关键词生物制品; 注册分类; 单克隆抗体; 被动免疫; 主动免疫_正文_《生物制品注册分类及申报资料要求》(2020年第43号) [1]规定，生物制品是指以微生物、细胞、动物或人源组织和体液等为起始原材料，用生物学技术制成，用于预防、治疗和诊断人类疾病的制剂。随着科学技术不断进步，生物制品更新迭代迅速，生物制品治疗用和预防用的功能逐渐交叠，单一类别的生物制品已经无法用治疗或者预防的功能进行固化界定，全球范围出现一系列创新型生物制品，如预防用单克隆抗体(以下简称为单抗) 和治疗用疫苗等。随着新型生物制品的出现，无法与现行生物制品注册分类进行匹配。本文对国内外生物制品的分类和注册申请路径进行比较，分析如何与时俱进调整注册分类方法，为创新生物制品的研发注册提供适宜的监管路径和程序。1我国生物制品定义和注册分类情况我国生物制品注册分类大体上分为2个阶段，第1阶段按产品列举方式分类，第2阶段按生物制品预期用途进行分类。1.1 生物制品注册按产品列举式分类1951年颁布的《生物制品法规》是我国最早的一部关于生物制品的法规，含12个通则和26个品种各论，是最早与疫苗有关的质量标准。1985年之前，我国的生物制药产业仍以传统生物制品为主，即疫苗和血液制品，总体上这个阶段批准的生物制品还是(预防用) 疫苗占主导地位。1985年卫生部颁布了第一部《新生物制品审批办法》[2]，首次将新生物制品按照产品类别划分为4项注册分类。1988年颁布《新生物制品审批办法补充规定》[3]，新生物制品与新药品难以区分者按以下办法处理。原则上按其用途，用作免疫预防者属于生物制品; 用作临床治疗者属于药品; 如该产品的生产工艺、质量控制标准及其检测方法接近生物制品者，虽属治疗用品仍按新生物制品审批程序申报，申报时需参考《新药审批办法》中有关技术要求。1993年原卫生部颁布《生物制品管理规定》[4]，仍沿用产品列举式分类。1.2 生物制品注册按预期用途分类随着生物制品种类增多，按产品列举式分类变得愈发困难，1999年新修订的《新生物制品审批办法》[5]中将生物制品申报按照用途分为治疗用新生物制品、预防用新生物制品和体外诊断用品。2002年，国家药品监督管理局颁布《药品注册管理办法(试行) 》(局令第35号) [6]，细化了生物制品的注册分类，将治疗用生物制品分为15类，包括单抗、基因治疗、体细胞治疗及其制品等。预防用生物制品也分为15类，均为疫苗。2005年，原国家食品药品监督管理局颁布《药品注册管理办法》以及2007年修订均延续了上述分类方式[7]。《药品注册管理办法》2020年版[8]自2020年7月1日正式实施。生物制品注册按照生物制品创新药、生物制品改良型新药、已上市生物制品(含生物类似药) 等进行分类。为规范生物制品注册申报和管理，《生物制品注册分类及申报资料要求》(2020年6月) 将生物制品分为预防用生物制品、治疗用生物制品和按生物制品管理的体外诊断试剂。其中，预防用生物制品是指为预防、控制疾病的发生、流行，用于人体免疫接种的疫苗类生物制品，包括免疫规划疫苗和非免疫规划疫苗，见表1。文章内容由凡默谷小编查阅文献选取，排版与编辑为原创。如转载，请尊重劳动成果，注明【来源：凡默谷公众号】。2新型生物制品带来的注册分类问题和挑战随着生物制药技术的飞速发展，越来越多的新型生物制品申报上市，一方面，以单抗为代表的非疫苗类预防用生物制品出现; 另一方面，同一类生物制品可能同时兼有预防用和治疗用等多重功能。目前生物制品的分类方式，将预防用和治疗用功能截然分开，且预防用生物制品等同为疫苗可能导致新型生物制品的注册分类难题。2.1 新型长效单抗无法纳入预防用生物制品类别单抗是由单一杂交瘤细胞产生，针对单一抗原表位的特异性抗体[9]。自1986年首个鼠源单抗muromonab-CD3 [10]经美国FDA批准上市用于治疗器官移植后同种异体排斥反应至今，全球已有100多种单抗获批上市，单抗在癌症、自身免疫性疾病和感染性疾病等疾病中发挥重要作用[11]。长期以来，单抗不可避免的高研发成本所致的昂贵售价并不亲民，并且频繁地注射给药也给患者带来诸多不便。因此，近年来，延长单抗半衰期成为抗体工程改造的重点。单抗半衰期的延长不仅可以减少给药频率，降低治疗费用，并且使单抗药物用于感染性疾病的预防变为可能。单抗原来半衰期约为11~30d[12]，经抗体工程改造后的单抗半衰期长达2~4个月[13]。目前的生物制品分类方式，预防用生物制品等同为疫苗可能导致全球范围内出现的创新型预防用长效单抗无法纳入预防用生物制品类别。2.1.1 预防呼吸道合胞病毒(respiratory syncytial virus，RSV) 感染长效单抗RSV是全球5岁以下儿童急性下呼吸道感染最常见的病毒病原，也是导致1岁以下婴儿罹患下呼吸道感染住院的首要病毒病原[14]。目前，尚无RSV疫苗和有效的抗病毒药物用于RSV感染的防治。一种可选择的预防RSV的方法是用单抗进行被动免疫预防。帕利珠单抗是目前唯一被FDA批准用于RSV被动免疫预防的单抗，仅用于患有先天性心脏病或肺部疾病的不足35周的早产儿，且半衰期短，需要每周注射。长效、全人源预防用RSV单抗一直是全球各国研发的热点。预防用长效单抗nirsevimab是首个完成全球Ⅲ期临床试验的单抗，与帕利珠单抗相比中和RSV活性高50倍[15]，具有超长半衰期，并扩大适用人群为所有婴幼儿[16-18]。其中，Ⅲ期临床研究证明单次肌内注射nirsevimab可在整个RSV流行季，给晚期健康早产儿及足月儿提供持续5个月的保护[17]。目前，我国已有3种用于预防RSV引起的下呼吸道疾病的长效单抗获批进入临床试验阶段，目标人群包括0~2岁的健康婴幼儿、早产儿和具有RSV高危因素的婴幼儿。尽管3款种长效单抗均通过被动免疫用于疾病预防，但由于不是疫苗，不符合我国目前预防用生物制品(等同为疫苗) 的注册分类，无法纳入预防用生物制品类别，因此在临床试验受理阶段暂纳入治疗用生物制品注册分类，见表2。2.1.2 预防疟疾感染长效单抗疟疾是疟原虫感染所致的地方性传染病，主要流行于热带和亚热带地区，疾病病死率较高。根据世界卫生组织最新报告[19]，2019年全球报告2.29亿例疟疾病例，逾40.9万例死于疟疾。目前已有3个用于预防(和治疗) 疟疾感染的单抗进入临床试验阶段(见表3) ，其中长效单抗L9LS是CIS43LS的下一代单抗，其针对的是CSP-1蛋白的一个更紧密的区域，具有高亲和力，保护效力是CIS43LS的3倍[20]。meplazumab是靶向CD147的单抗药物，2020年1月获美国FDA批准开展用于治疗和预防严重疟疾的Ⅰ期临床试验。2022年8月4号，一项旨在预防疟疾感染的新型单抗L9LS的Ⅰ期临床试验结果在《新英格兰医学杂志》上发表。试验旨在评估L9LS对从未患过疟疾或未接种疟疾疫苗的健康成年人的安全性和药动学，以及人疟疾感染的保护效力。试验通过皮下注射或静脉注射给予L9LS，在接受抗体注射的2~6周内，让所有参与者都暴露于携带疟原虫的蚊子，暴露后几周内，研究人员观察到几乎所有的受试者都得到了保护。L9LS经抗体工程优化(LS突变) ，半衰期为56d，对于5岁以下的儿童，1次皮下注射可能提供至少6个月的保护效力[21]。2.1.3 新型冠状病毒肺炎(COVID-19) 暴露前预防长效单抗COVID-19暴发以来，疫苗在控制病毒传播和降低死亡率方面发挥着重要作用，是向大多数人提供COVID-19保护的最适当措施。此外，在未接种疫苗或对疫苗有不良反应的人群(如免疫功能低下的个人) 中，长效单抗可提供暴露前被动免疫预防作用。恩适得(Evusheld，tixagevimab与cilgavimab的组合) 是目前全球唯一一款用于COVID-19暴露前预防的单抗组合药物，2021年12月获得美国FDA的紧急使用授权，2022年3月获得欧洲EMA上市许可，2022年6月通过海南博鳌乐城国际医疗旅游先行区特殊进口审批，适用于成人和青少年(年龄≥12岁且体重≥40 kg) 的新冠病毒暴露前预防。Evusheld获批美国FDA紧急使用授权是基于PROVENTⅢ期暴露前预防临床试验数据，与安慰剂相比，Evusheld组受试者出现COVID-19症状的风险在统计学上显著降低(初步分析为77%，中位6个月随访时为83%) ，病毒防护效果持续至少6个月[22]。2.2 同类产品同时具有预防和治疗功能随着免疫学研究的发展，疫苗的研发和应用逐渐延伸，从传染病扩大到系统性疾病，包括癌症; 从预防用扩大到治疗用。全球范围内，卡介苗主要用作预防儿童结核病的预防接种疫苗，接种对象为出生3个月以内的婴儿或用旧结核菌素试验阴性的儿童。除用作结核病疫苗外，卡介苗还是非肌层浸润性膀胱癌的主要治疗手段。1976年，Morales医生首次将卡介苗直接注入膀胱，治疗复发性浅表膀胱癌获得成功[23]。随后大量的临床观察和研究表明，卡介苗灌注治疗术后残存膀胱癌的完全缓解率为50%~90%(平均70%) ，有效降低了膀胱癌复发率，推迟癌症复发和病情进展[24]。尽管卡介苗预防结核病和治疗膀胱癌的用法不同，但都是通过激活机体的免疫系统，增强主动免疫功能发挥药理作用。除卡介苗之外，全球已有多款治疗性疫苗上市，见表4。2010年4月29日，美国FDA批准Provenge疫苗，是以患者自身免疫细胞制成的前列腺癌免疫疗法，开创了癌症免疫治疗的新时代。疫苗可以是治疗用或者预防用，但是本质上是同一类通过主动免疫产生免疫应答的产品。而目前的生物制品分类方式，将产品的预防用和治疗用功能截然分开。2.3 基于免疫学原理看生物制品的创新问题人工免疫是指人为地使机体获得适应性免疫，包括2种: 人工主动免疫是用疫苗接种机体，使之主动产生适应性免疫应答，从而预防和治疗疾病的措施; 人工被动免疫是给人体注射含特异性抗体等制剂，使之被动获得适应性免疫应答，以治疗或紧急预防疾病的措施，见图1 [9]。目前生物制品的注册分类方式，主动免疫制剂纳入预防用生物制品，而被动免疫制剂纳入治疗用生物制品。2.3.1 被动免疫制剂和主动免疫制剂都可以用于预防疾病一个世纪以来，被动免疫制剂已成功应用于狂犬病、破伤风和乙型肝炎等一系列疾病疑似暴露的暴露后预防或感染后的辅助治疗。随着科学技术飞速发展，以健康人预防用长效单抗为代表的被动免疫制剂可能为某些传染病的预防提供干预手段，如RSV、疟疾等。因为这些疾病疫苗研发难度大，目前仍缺乏有效预防手段，造成严重的疾病负担。世界卫生组织为此推出了一系列单抗预防疾病的理想产品特性清单[25-27]。尽管被动免疫保护效力较短，但用单抗进行被动免疫相较于疫苗进行主动免疫有以下优势: ①被动免疫起效快，即时就会有保护作用。而且在免疫抑制的个体中仍具有保护效力，这些个体往往疾病感染风险最高。②新技术可以简化单抗的生产或给药，如延长抗体的半衰期或注射编码单抗的mRNA。③生产过程通用，原则上可以在短时间快速开始生产，在疫情暴发时迅速提供产品。2.3.2 被动免疫制剂和主动免疫制剂都可以用于治疗疾病免疫治疗是指利用免疫学原理，针对疾病的发生机制，人为地干预或调整机体的免疫功能，达到治疗疾病目的所采取的措施，包括主动或被动免疫治疗[9]。美国批准抗前列腺癌治疗性疫苗上市，促进了抗肿瘤治疗性疫苗的研发，治疗性疫苗已然成为医药生物技术与产业化的热点之一。治疗性疫苗是指机体在感染或发生疾病后，用诱导机体产生特异性免疫或非特异性免疫的方法，防止疾病的发生、发展，或促进已产生疾病的机体恢复健康，多用于慢性感染或肿瘤的治疗[28]。各种治疗性疫苗的作用机制与途径不尽相同，但最基本的理论基础总是围绕如何调节机体的免疫应答，或增强或降低，以达到对所患疾病有不同程度的缓解、控制甚至治愈的效果。基于免疫学原理，预防疾病的生物制品除了主动免疫制剂，如疫苗类生物制品，还包括以预防为目的的被动免疫制剂，如健康人预防用单抗等新型生物制品。3典型国家和地区生物制品分类和注册申请路径3.1 生物制品分类3.1.1 美国的生物制品分类FDA对“生物制品”定义为[29]: 由FDA监管，用于诊断、预防、治疗和治愈疾病和病症，通常是一类大而复杂的分子，并且种类繁多的产品。此类产品通常运用生物技术在生物体中产生，如微生物、植物细胞或动物细胞，并且比小分子药物更难表征。2003年6月30日，FDA将生物制品评价和研究中心(CBER) 审评和监管的一些生物制品转移到药品评价和研究中心(CDER) [30]。CDER对转移的生物制品负有监管责任，两大中心共同促进美国生物制品监管的发展。其中细胞产品，基因治疗产品，疫苗和疫苗相关产品，变态反应原制品，抗毒素、抗蛇毒血清和蛇毒，血液、血液成分、血浆衍生品，人体细胞、组织、细胞-组织产品归属CBER监管。单抗、治疗用蛋白(疫苗和血液制品除外) 、免疫调节剂、生长因子、细胞因子归属于CDER监管。3.1.2 欧盟的生物制品分类在欧盟，生物制品包括3类: 使用生物技术生产的生物制品、先进治疗产品(ATMP) 和其他生物制品。使用生物技术生产的生物制品申请由EMA的人用药品委员会(CHMP) 负责审评，先进治疗产品由先进疗法委员会(CAT) 负责评估产品的质量、有效性和安全性[31]，以上2类产品通过集中审批程序获得授权。其他生物制品(如天然衍生生物制品) 可以在各个成员国获得国家授权，而不通过集中审批程序。3.1.3 日本的生物制品分类在日本，对生物制品的潜在感染传播风险进行合理科学评估的基础上将生物制品分为特定生物制品、生物制品和其他生物制44品(见图2) [32]。此外，日本将细胞和基因产品等独立出来归于再生医疗产品，进行单独管理，并在修订的《药品和医疗器械法》中增订了再生医学产品监管的部分。3.1.4 生物制品的分类差异除我国将生物制品分为治疗用、预防用和诊断用进行注册分类外，美国、欧盟和日本并未进行这样划分，见表5。国际上对生物制品分类的考虑因素包括生物制品的生产来源、生物技术的先进性、分子大小和表征复杂性等。欧盟和日本在传统生物制品之外，分别增加先进疗法和再生医学产品的分类。通常，生物制品注册分类由各国药品监管机构制定用于生物制品上市审评审批，由于各国监管机构对生物制品的分类考量因素不同，因此各国分类各异。但是考虑到部分新型生物制品，包括先进疗法药品等的研发创新，具有区别于传统药物的独特属性，包括治愈潜力、一次性治疗、高额的前期费用、复杂的生产过程和严格的运输条件，因此在生物制品注册分类时纳入“先进性”的考量因素，有助于促进创新，提高ATMPs等新型生物制品的可及性。3.2 注册申请路径3.2.1 美国的生物制品注册申请路径①新生物制品注册申请路径。生物制品通过生物制品许可申请(BLA) 路径上市，其中新生物制品一般通过PH-SA351(a) 路径申请，在该路径下需要完整的CMC、非临床以及临床研究数据，即包含完整研发资料的生物制品上市申请。②生物类似药注册申请路径。2010年修订的PHSA中351(k) 节中授予了FDA批准生物类似药的权利并且设立了生物类似药简化申请路径。生物类似药只要证明与FDA已许可的生物制品具有生物相似性或可互换性即可通过简化申请路径申请。3.2.2 欧盟的生物制品注册申请路径欧盟对所有生物制品的注册申请路径分为2类: ①完整资料申请路径，欧盟2001/83/EC指令第8条第3款规定，完整资料申请应当提交全面、完整且没有任何研究/试验报告的简化，包括药学(物理化学、生物、微生物) 试验、非临床与临床试验结果等在内的申报资料。②生物类似药的简化申请路径，生物类似药申请，即满足2001/83/EC第十条第四款规定的简化申请。简化申请与完整申请相比，在非临床研究以及临床试验部分，可以提交简化的申报资料，或者只需要提交生物利用度研究证明生物等效性即可。3.2.3 日本的生物制品注册申请路径日本的药品审评注册分类不划分为“化学药品”和“生物制品”，而是以“新药”、“改良型”和“仿制药”(生物类似药) 的基本逻辑来划分。具体包括: ①含有新有效成分的药品。②新医疗用复方制剂。③新给药途径药品。④新适应证药品。⑤新剂型药品。⑥新用量药品。⑦生物类似物。⑧增加新剂型的药品。⑨类似处方医疗用复方制剂。⑩其他处方药。依据2005年3月31日，日本厚生劳动省医药食品局发布《关于药品生产销售的批准申请通知》(第0331015号令) 。按照药品的创新程度以及申报资料的完整程度，注册分类1类到10类的处方药品，随着其创新难度的降低，其注册申请所要求的资料也逐渐简化。3.2.4 生物制品的注册申请路径差异从各国生物制品的注册申请路径来看，只有我国把生物制品分为治疗用和预防用2类。美国和欧盟的生物制品注册分类按照“创新”和“仿制”(生物类似药) 的原则，将注册申请路径分为完整申请路径和简化申请路径，日本按照药品的创新程度以及申报资料的完整程度将注册分类分成1~10类，见表6。4关于生物制品分类体系的思考与建议4.1 建立持续改进的生物制品分类体系科学的本质在于分类，对生物制品的注册分类进行适时调整是适应生物制品创新和产业发展，紧跟科学技术进步的必然要求。随着科学和技术的发展，生物制品治疗与预防的功能逐渐交叠，未来生物制品的注册分类不适合按照产品类别进行预防用和治疗用的简单功能区分，应当按照国际通行的创新、改良和生物类似药的分类逻辑进行申报资料规定。考虑到我国一直以来对疫苗有单独注册要求，建议新的生物制品注册分类见图3。4.2 区分传统生物制品与先进疗法产品先进疗法产品包括基因治疗产品、细胞治疗产品和组织工程产品，这些高度复杂的治疗产品无论是生产和给药途径，还是临床疗效均不同于传统药物。一些基因治疗产品可以解决疾病的病因，为患者提供一次性治愈的机会，也有一些细胞治疗产品和组织工程产品是专门为特定患者而生产的，形成个体化定制药物[33]。将先进疗法产品与传统生物制品进行注册区分(图3) ，有利于监管部门制定一系列监管策略，支持新的先进疗法产品的早期开发，以便促进患者可以更早获得这类产品。5结语随着生物制药技术的飞速发展，全球涌现出一系列的创新型生物制品，如预防用单抗和治疗用疫苗等。目前生物制品的注册分类按照产品类别进行预防用和治疗用的简单功能区分，新型生物制品可能将面临注册分类与实际用途不匹配的问题。建立持续改进的生物制品分类体系，区分传统生物制品和先进疗法产品，有利于生物制品的创新和产业发展，便于监管部门制定监管策略，助力患者更早获得创新产品。参考文献详见 《中国新药杂志》2022年第31卷第24期文章信息源于公众号中国新药杂志 ，登载该文章目的为更广泛的传递行业信息，不代表赞同其观点或对其真实性负责。文章版权归原作者及原出处所有，文章内容仅供参考。本网拥有对此声明的最终解释权，若无意侵犯版权，请联系小编删除。学如逆水行舟，不进则退；心似平原走马，易放难收。行舟Drug每日更新 欢迎订阅+医药大数据|行业动态|政策解读
疫苗
2022-11-01
One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa, a National Institutes of Health clinical trial has found. The antibody was up to 88.2% effective at preventing infection over a 24-week period, demonstrating for the first time that a monoclonal antibody can prevent malaria infection in an endemic region.
One dose of an antibody drug safely protected healthy, non-pregnant adults from malaria infection during an intense six-month malaria season in Mali, Africa, a National Institutes of Health clinical trial has found. The antibody was up to 88.2% effective at preventing infection over a 24-week period, demonstrating for the first time that a monoclonal antibody can prevent malaria infection in an endemic region. These findings were published today in The New England Journal of Medicine and presented at the American Society of Tropical Medicine & Hygiene 2022 Annual Meeting in Seattle.
"We need to expand the arsenal of available interventions to prevent malaria infection and accelerate efforts to eliminate the disease," said Anthony S. Fauci, M.D., director of the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH. "These study results suggest that a monoclonal antibody could potentially complement other measures to protect travelers and vulnerable groups such as infants, children, and pregnant women from seasonal malaria and help eliminate malaria from defined geographical areas."
NIAID sponsored and funded the trial, which was led by Peter D. Crompton, M.D., M.P.H., and Kassoum Kayentao, M.D., M.P.H., Ph.D. Dr. Crompton is chief of the Malaria Infection Biology and Immunity Section in the NIAID Laboratory of Immunogenetics, and Dr. Kayentao is a professor at the University of Sciences, Techniques and Technologies (USTTB) of Bamako, Mali.
An estimated 241 million cases of malaria occurred worldwide in 2020, according to the World Health Organization (WHO), resulting in an estimated 627,000 deaths, mostly in children in sub-Saharan Africa. These cases included more than 11 million pregnant women in Africa, resulting in an estimated 819,000 newborns with low birthweight and thus at increased risk for illness and death.
The only malaria vaccine currently recommended by WHO, called RTS,S (Mosquirix), provides partial protection against clinical malaria during the early years of life when given to children aged 5 to 17 months in four doses over a 20-month period. Other drugs consisting of small chemical compounds that effectively prevent malaria infection are also available for infants and young children as well as travelers. The requirement for frequent dosing of these drugs can limit adherence, however, and the emergence of drug resistance may also limit their usefulness. Thus, there is an urgent need for new, fast-acting, infrequently dosed interventions that safely provide strong protection against malaria infection.
Malaria is caused by Plasmodium parasites, which are transmitted to people through the bite of an infected mosquito. The mosquito injects the parasites in a form called sporozoites into the skin and bloodstream. These travel to the liver, where they mature and multiply. Then the mature parasite spreads throughout the body via the bloodstream to cause illness. P. falciparum is the Plasmodium species most likely to result in severe malaria infections, which, if not promptly treated, may lead to death.
The Phase 2 NIAID-USTTB trial evaluated the safety and efficacy of a one-time, intravenous infusion of a monoclonal antibody called CIS43LS. This antibody was previously shown to neutralize the sporozoites of P. falciparum in the skin and blood before they could infect liver cells. Researchers led by Robert A. Seder, M.D., isolated a naturally occurring form of this antibody from the blood of a volunteer who had received an investigational malaria vaccine, and then modified the antibody to extend the length of time it would remain in the bloodstream. Dr. Seder is the acting chief medical officer and acting associate director of the NIAID Vaccine Research Center (VRC) and chief of the VRC's Cellular Immunology Section.
The study team for the Phase 2 trial enrolled 369 healthy, non-pregnant adults aged 18 to 55 years in the rural communities of Kalifabougou and Torodo in Mali, where intense P. falciparum transmission typically occurs from July through December each year.
The first part of the trial assessed the safety of three different doses of CIS43LS -- 5 milligrams per kilogram of body weight, 10 mg/kg and 40 mg/kg -- administered by intravenous infusion in 18 study participants, with six participants per dose level. The study team followed these participants for 24 weeks and found the antibody infusions were safe and well-tolerated.
The second part of the trial assessed the efficacy of two different doses of CIS43LS compared to a placebo. Three hundred and thirty participants were assigned at random to receive either 10 mg/kg of the antibody, 40 mg/kg, or a placebo by intravenous infusion. No one knew who was assigned to which group until the end of the trial. The study team followed these individuals for 24 weeks, testing their blood for P. falciparum weekly for the first 28 days and every two weeks thereafter. Any participant who developed symptomatic malaria during the trial received standard treatment from the study team.
The investigators analyzed the efficacy of CIS43LS two ways. Based on the time to first P. falciparum infection over the 24-week study period, the high dose (40 mg/kg) of CIS43LS was 88.2% effective at preventing infection and the lower dose (10 mg/kg) was 75% effective. An analysis of the proportion of participants infected with P. falciparum at any time over the 24-week study period found the high dose was 76.7% at preventing infection and the lower dose was 54.2% effective.
"These first field results demonstrating that a monoclonal antibody safely provides high-level protection against intense malaria transmission in healthy adults pave the way for further studies to determine if such an intervention can prevent malaria infection in infants, children, and pregnant women," Dr. Seder said. "We hope monoclonal antibodies will transform malaria prevention in endemic regions."
Dr. Seder and colleagues have developed a second antimalarial monoclonal antibody, L9LS, that is much more potent than CIS43LS and therefore can be administered in a smaller dose as an injection under the skin (subcutaneously), rather than by intravenous infusion. An early-phase NIAID trial of L9LS in the United States found that the antibody was safe and prevented malaria infection for 21 days in 15 out of 17 healthy adults exposed to P. falciparum in a carefully controlled setting. Two larger, NIAID-sponsored Phase 2 trials assessing the safety and efficacy of L9LS in infants, children and adults are underway in Mali and Kenya.
Additional information about the Phase 2 trial of CIS43LS is available at ClinicalTrials.gov under study identifier NCT04329104.
抗体疫苗
100 项与 L-9LS 相关的药物交易
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 疟疾 | 临床2期 | 马里 | 2022-03-18 |
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
临床2期 | 384 | two-dose L9LS | 鏇襯憲鹽窪選鑰獵鏇餘(積窪蓋製繭鏇醖壓衊鏇) = grade 3 or worse treatment-related adverse events occurred after four (1%) of 384 L9LS injections and two (1%) of 338 placebo injections; these events all resolved by study end 衊齋遞膚蓋襯齋繭鏇範 (構選夢廠鏇鏇醖壓鹽壓 ) 更多 | 积极 | 2026-04-01 | ||
Placebo | |||||||
临床2期 | 490 | (L9LS 900 mg) | 餘餘繭觸鬱簾餘簾糧蓋 = 膚網構醖願顧網繭鑰蓋 鏇觸簾繭構鏇簾壓範網 (顧繭築衊艱鹹選遞鹽憲, 顧願憲選糧衊膚鑰製憲 ~ 網選憲憲衊鏇蓋壓築淵) 更多 | - | 2025-04-02 | ||
Placebo (Placebo) | 餘餘繭觸鬱簾餘簾糧蓋 = 製壓艱顧範膚築蓋鹹觸 鏇觸簾繭構鏇簾壓範網 (顧繭築衊艱鹹選遞鹽憲, 壓鹽製艱憲範壓淵窪網 ~ 選憲淵顧廠築鏇膚願憲) 更多 | ||||||
临床2期 | 225 | 顧壓範齋鹽壓鬱窪鏇積(繭獵膚顧鹹遞餘窪餘窪) = 廠鑰網廠艱構範膚淵積 築製鑰簾網鏇簾衊鬱願 (鹹糧壓餘鬱鏇遞膚衊鬱 ) 更多 | 积极 | 2024-04-26 | |||
顧壓範齋鹽壓鬱窪鏇積(繭獵膚顧鹹遞餘窪餘窪) = 壓鏇觸觸觸鹹夢餘蓋窪 築製鑰簾網鏇簾衊鬱願 (鹹糧壓餘鬱鏇遞膚衊鬱 ) 更多 | |||||||
临床1期 | 32 | Plasmodium falciparum (P. falciparum) sporozoite challenge+VRC-MALMAB0114-00-AB (Group 1: L9LS (1 mg/kg IV)) | 鏇鹽餘淵鹽範繭窪膚鑰 = 襯遞獵構壓艱夢鏇構艱 憲憲顧艱網製膚鑰簾醖 (願廠窪衊夢範鬱願齋鏇, 艱範鬱範觸淵蓋簾築遞 ~ 獵網製選鏇網鑰顧簾積) 更多 | - | 2023-10-13 | ||
Plasmodium falciparum (P. falciparum) sporozoite challenge+VRC-MALMAB0114-00-AB (Group 2: L9LS (5 mg/kg IV)) | 鏇鹽餘淵鹽範繭窪膚鑰 = 餘窪膚衊範鏇襯鹽醖鹽 憲憲顧艱網製膚鑰簾醖 (願廠窪衊夢範鬱願齋鏇, 鏇範構蓋鑰蓋遞顧廠淵 ~ 衊餘觸鹽鬱築鏇糧網獵) 更多 |
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