预约演示
更新于：2026-08-20
Bevacizumab biosimilar(Boehringer)
贝伐珠单抗生物类似药(Boehringer)
更新于：2026-08-20
概要
基本信息
在研机构- |
权益机构- |
最高研发阶段无进展临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
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结构/序列
Sequence Code 41632H
当前序列信息引自: *****
Sequence Code 41637L
当前序列信息引自: *****
关联
6
项与 贝伐珠单抗生物类似药(Boehringer) 相关的临床试验NCT05087992
A Phase Ia/Ib, Open Label, Multicentre, Dose Escalation Study of BI 905711 in Combination With Chemotherapy Followed by Expansion Cohorts in Patients With Advanced Gastrointestinal Cancers
This study is open to adults with advanced colorectal cancer or with advanced pancreatic cancer. The study has 2 parts. In the first part, participants with colorectal cancer get a medicine called BI 905711 combined with chemotherapy and bevacizumab. The purpose of the first part is to find the highest BI 905711 dose participants can tolerate. In the second part, participants with colorectal cancer or pancreatic cancer get BI 905711 combined with chemotherapy. Some participants also get bevacizumab. The second part tests whether BI 905711 makes tumours shrink. Participants get BI 905711, chemotherapy and bevacizumab about every 2 weeks as an infusion into a vein. Participants can stay in the study as long as they benefit from treatment and can tolerate it. The doctors regularly check the health of the participants and note any health problems that could have been caused by the study treatment. The doctors also monitor the size of the tumour.
开始日期2021-11-24 |
申办/合作机构 |
NCT02776683
A Single Arm, Open-label, Multicenter, Multinational, Safety and Efficacy Phase IIIb Trial of BI 695502 Plus mFOLFOX6 in Patients With Previously Untreated Metastatic Colorectal Cancer
The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response [CR] plus partial response [PR]), overall survival (OS), duration of response (DOR), time to progression (TTP).
开始日期2016-06-08 |
申办/合作机构 |
NCT02272413
A Multicenter, Randomized, Double-blind Phase III Trial to Evaluate Efficacy and Safety of BI 695502 Plus Chemotherapy Versus Avastin® Plus Chemotherapy in Patients With Advanced Nonsquamous Non-Small Cell Lung Cancer
The objective of this phase III trial is to establish statistical equivalence in terms of efficacy (best overall response rate [ORR], proportion of patients with complete response [CR] plus partial response [PR]) until 18 weeks of first-line treatment with BI 695502 plus chemotherapy versus Avastin® plus chemotherapy followed by maintenance monotherapy with either BI 695502 or Avastin®.
开始日期2015-07-08 |
申办/合作机构 |
100 项与 贝伐珠单抗生物类似药(Boehringer) 相关的临床结果
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100 项与 贝伐珠单抗生物类似药(Boehringer) 相关的转化医学
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100 项与 贝伐珠单抗生物类似药(Boehringer) 相关的专利（医药）
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1
项与 贝伐珠单抗生物类似药(Boehringer) 相关的文献（医药）2022-01-01·JTO clinical and research reports
Phase 3 Trial of BI 695502 Plus Chemotherapy Versus Bevacizumab Reference Product Plus Chemotherapy in Patients With Advanced Nonsquamous NSCLC
Article
作者: Rohr, Klaus B ; Schliephake, Dorothee ; Balser, Sigrid ; Liedert, Bernd ; Kim, Edward S ; Lohmann, Ragna
INTRODUCTION:
Biological therapies such as bevacizumab have improved survival in patients with NSCLC. This study was conducted to confirm the equivalent efficacy of the biosimilar candidate BI 695502 to the bevacizumab reference product (RP).
METHODS:
In this phase 3, multicenter, randomized, double-blind trial of adult patients with recurrent or metastatic NSCLC received up to 18 weeks of induction treatment with BI 695502 or bevacizumab RP 15 mg/kg plus paclitaxel and carboplatin. Subsequent maintenance therapy comprised BI 695502 or bevacizumab RP monotherapy until disease progression or unacceptable toxicity. The primary end point was the best overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 assessed by central imaging review, until 18 weeks after the start of treatment.
RESULTS:
In total, 671 patients were randomized at one-to-one ratio to BI 695502 or bevacizumab RP, of whom 335 and 328, respectively, received treatment. Of these, 228 (68.1%) and 256 (78.0%), respectively, proceeded to maintenance monotherapy. A manufacturing issue led to a small number of patients treated with BI 695502 switching to bevacizumab RP late in the study. The primary end point, best ORR, was 54.0% in the BI 695502 group and 63.1% in the bevacizumab RP group. The 90% confidence interval for the between-group ratio of best ORR (0.770 to 0.951) was within the prespecified range for equivalence (0.736-1.359). Adverse events were class-related and similar between the two treatment arms.
CONCLUSIONS:
This study revealed equivalent ORR after 18 weeks of treatment with BI 695502 or bevacizumab RP, with similar adverse event profiles.
19
项与 贝伐珠单抗生物类似药(Boehringer) 相关的新闻（医药）2026-08-06
Raises Full Year 2026 Revenue and Cash Outlook Driven by Continued Business Momentum
Conference Call to Begin Today at 4:30 p.m. ET
EMERYVILLE, Calif.--(BUSINESS WIRE)-- OmniAb, Inc. (NASDAQ: OABI), a provider of cutting-edge discovery research technology to enable the discovery of next-generation therapeutics, today reported financial results for the three and six months ended June 30, 2026, provided operating and partner program progress, and updated 2026 financial guidance.
“We are pleased to report a strong quarter and to increase our revenue and cash outlook for 2026 based on continued momentum in our business. Recent updates from partner programs have been very encouraging with important advancements in clinical development,” stated Matt Foehr, Chief Executive Officer of OmniAb. “We continue to efficiently leverage and expand the reach of our core and highly differentiated discovery technologies, as we also focus on our promising xPloration® platform. We recently expanded our executive leadership with the addition of Chief Operating Officer Amechi Nwachuku, who has quickly integrated into our team to drive and strengthen this area. We believe we’re well positioned to accelerate growth, and we look forward to providing business updates and technology highlights and plans at our October Investor and Analyst Day.”
Second Quarter 2026 Financial Results
Revenue for the second quarter of 2026 was $13.4 million, compared with $3.9 million in the prior-year period, with the increase driven primarily by milestone revenue. Service revenue increased primarily due to the commencement of new ion channel programs, and xPloration revenue increased on higher instrument sales and related consumables.
Cost of xPloration revenue was $0.6 million for the second quarter of 2026, compared with $0.3 million for the same period in 2025. The increase was due to increased instrument and consumable sales. Research and development expense was $9.6 million for the second quarter of 2026, compared with $10.9 million for the same period in 2025, with the decrease due to lower personnel expense related to share-based compensation and salary expense and lower facility-related costs. General and administrative expense was $6.7 million for the second quarter of 2026, compared with $7.7 million for the same period in 2025, with the decrease primarily due to lower personnel expense related to share-based compensation and salary expense and lower professional fees.
Amortization of intangibles decreased to $3.1 million for the second quarter of 2026, compared with $3.2 million for the same period in 2025. Other operating expense (income) increased to $0.2 million for the second quarter of 2026 from ($1.9) million for the same period in 2025, primarily as a result of a net $2.0 million one-time gain from the sale of a small-molecule program in the second quarter of 2025.
Total costs and operating expenses were $20.1 million for the second quarter of 2026, flat with $20.1 million for the same period in 2025.
Cash costs and operating expenses were $13.3 million for the second quarter of 2026, compared with $11.9 million for the same period in 2025 (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure).
Net loss for the second quarter of 2026 was $5.9 million, or $0.05 per share, compared with a net loss of $15.9 million, or $0.15 per share, for the same period in 2025.
Year-to-Date Financial Results
Revenue for the first half of 2026 was $27.8 million, compared with $8.1 million for the same period in 2025, with the increase primarily related to milestone revenue. Service revenue increased primarily due to the commencement of new ion channel programs, and xPloration revenue increased on higher instrument sales and related consumables.
Cost of xPloration revenue was $0.6 million for the first half of 2026, compared with $0.3 million for the same period in 2025. The increase was due to increased instrument and consumable sales. Research and development expense was $19.2 million for the first half of 2026, compared with $23.5 million for the same period in 2025, with the decrease due to lower personnel expense related to share-based compensation and salary expense, lower external expenses associated with legacy small-molecule ion channel programs and lower facility-related costs. General and administrative expense was $13.3 million for the first half of 2026, compared with $15.6 million for the same period in 2025, with the decrease primarily due to lower personnel expense related to share-based compensation and salary expense and lower professional fees.
Amortization of intangibles increased to $9.1 million for the first half of 2026, compared with $6.5 million for the same period in 2025, primarily due to a $2.9 million non-cash impairment related to the discontinuation of certain legacy small-molecule ion channel programs recorded in the first quarter of 2026.
Other operating expense (income) for the first half of 2026 was $0.1 million compared to ($2.7) million for the same period in 2025. The prior-year period included a net $2.0 million one-time gain from the sale of a small-molecule program in the second quarter of 2025.
Total costs and operating expenses were $42.3 million for the first half of 2026, compared with $43.1 million for the same period in 2025.
Cash costs and operating expenses were $25.5 million for the first half of 2026, compared with $26.6 million for the same period in 2025 (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure).
Net loss for the first half of 2026 was $13.6 million, or $0.11 per share, compared with a net loss of $34.1 million, or $0.32 per share, for the same period in 2025.
As of June 30, 2026, OmniAb had cash, cash equivalents and short-term investments of $52.0 million.
2026 Financial Guidance
OmniAb revises 2026 financial guidance and now expects revenue to be in the range of $32 million to $36 million, versus $28 million to $33 million previously, and costs and operating expenses to be in the range of $84 million to $88 million, versus $83 million to $88 million previously. Cash costs and operating expenses are expected to be in the range of $51 million to $55 million, versus $50 million to $55 million previously (see note regarding "Use of Non-GAAP Financial Measure" below for further discussion of this non-GAAP measure). The Company now expects to end the year with cash and cash equivalents in the range of $37 million to $41 million, versus $33 million to $38 million previously. The full-year 2026 effective tax rate is expected to be approximately 0%.
Second Quarter 2026 and Recent Business Highlights
During the second quarter of 2026, OmniAb entered into new license agreements with EnRosa Therapeutics and argenx. As of June 30, 2026, the Company had 110 active partners and 425 active programs, including 34 OmniAb-derived programs in clinical development or being commercialized.
Business and partner highlights from the second quarter of 2026 and recent weeks included the following:
JNJ-5322
Ramantamig (JNJ-79635322), a tri-specific antibody targeting (BCMA x GPRC5D x CD3), has advanced to Phase 3 from Phase 1 clinical trials. The Phase 3 study is randomized study comparing JNJ-79635322 and an anti-BCMAxCD3 bispecific antibody in participants with relapsed or refractory multiple myeloma who have received at least three prior lines of therapy including a PI, an IMiD, and an anti CD38 antibody.
Precemtabart tocentecan (M9140)
Merck KGaA, announced the first patient has been dosed in the Phase 3 PROCEADE®-CRC-03 trial evaluating precemtabart tocentecan, a potential first‑in‑class investigational anti‑CEACAM5 antibody‑drug conjugate (ADC), for the treatment of metastatic colorectal cancer based on Phase 1 data. The Phase 3 study will assess the efficacy and safety of precemtabart tocentecan, alone or with bevacizumab, in patients with metastatic colorectal cancer who are intolerant- or refractory-to, or progressed after, systemic therapies. Phase 1 data from the PROCEADE-CRC-01 study showed predictable and manageable safety in more than 100 patients with heavily pretreated metastatic colorectal cancer. At the recommended dose for Phase 3 development (2.8 mg/kg Q3W; n=29), confirmed objective response rate was 20.7% (95% CI: 8.0, 39.7), median PFS was 6.9 months (95% CI: 4.4, 9.5), and median OS was not reached after a median follow-up of 13.1 months (95% CI: 8.7, NE).
TEV- '408
Teva Pharmaceuticals announced plans for its TEV-’408, an investigational anti-interleukin-15 monoclonal antibody, to advance into a Phase 2b study in vitiligo in the fourth quarter of 2026 following encouraging results from an ongoing Phase 1b, open-label study in adults with active or stable non-segmental vitiligo (NSV). Topline results in Phase 1b trial evaluating TEV-'408 for vitiligo showed improvements in skin pigmentation in patients with active or stable NSV. TEV-’408 was well-tolerated with no safety signals observed. At baseline, 66% of enrolled participants had vitiligo affecting more than 10% of body surface area, representing a population with limited treatment options. At week 24, in evaluable participants, nearly 75% of patients reported improvement in facial vitiligo, with half reporting “much” or “very much” improved, 42% achieved F-VASI50 and 21% achieved F-VASI75, 55% of patients reported improvement in total body vitiligo, and 7% achieved T-VASI50. Teva Pharmaceuticals and Royalty Pharma entered into a funding agreement of up to $500 million to accelerate the clinical development of TEV-'408 for vitiligo. Topline results of the Phase 2a trial evaluating TEV-'408 for celiac disease continue to be expected in the second half of 2026.
IMVT-1402
Immunovant announced preliminary week 16 IMVT-1402 results in the difficult-to-treat rheumatoid arthritis trial that showed clinically meaningful response rates of 72.7% ACR20, 54.5% ACR50 and 35.8% ACR70. Immunovant’s development plans for IMVT-1402 remain on track across all six announced indications. They expect to provide further updates on the potentially registrational IMVT-1402 difficult-to-treat rheumatoid arthritis program and report topline data from the proof-of-concept trial of IMVT-1402 in cutaneous lupus erythematosus in the second half of calendar year 2026. In calendar year 2027, topline data are anticipated for the potentially registrational trials evaluating IMVT-1402 in Graves’ disease and myasthenia gravis. Topline data are expected to follow in calendar year 2028 for the potentially registrational trials of IMVT-1402 in chronic inflammatory demyelinating polyneuropathy and Sjögren’s disease.
BI 3802876
Boehringer Ingelheim has commenced its Phase 2a double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of BI 3802876 in participants with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). The study is to evaluate BI 3802876 tolerance and dose response in MASH patients.
Sugemalimab
Arrotex Pharmaceuticals entered into an exclusive commercialization agreement with CStone Pharmaceuticals for Sugemalimab, a fully human anti–PD-L1 monoclonal antibody, covering all approved and future indications in Australia and New Zealand. The agreement includes potential commercialization across stage III and IV non-small cell lung cancer, gastric cancer, esophageal squamous cell carcinoma, and extranodal NK/T-cell lymphoma, subject to regulatory approval by Australia's Therapeutic Goods Administration.
VXA-222
VERAXA Biotech announced the advancement of bispecific ADC (bsADC) program VXA-222, following successful achievement of a key technical milestone in its alliance with OmniAb. The program is moving into its next collaboration phase with OmniAb's discovery work successfully concluded. VXA-222 utilizes an “AND-gate” logic to address two different target antigens present on solid tumors with one molecule.
Additional Updates
The company appointed Amechi Nwachuku to the newly-created position of Executive Vice President and Chief Operating Officer, primarily responsible for managing the strategy, operations and commercial maximization of xPloration. OmniAb will host an Investor and Analyst Day on October 6, 2026 at its corporate headquarters in Emeryville, CA. The agenda for the day will include presentations by management, panel discussions, and a lab tour for those attending in-person. For additional information and participation details, please visit.
Conference Call and Webcast
OmniAb management will host a conference call with accompanying slides today beginning at 4:30 p.m. ET (1:30 p.m. PT) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 461-5787 using the conference ID 545137839. Slides, as well as the live and replay webcast, are available here.
About OmniAb®
OmniAb licenses cutting-edge discovery research technology to pharmaceutical and biotech companies and academic institutions to enable the discovery of next-generation therapeutics. Our technology platform creates and screens diverse antibody repertoires and is designed to quickly identify optimal antibodies and other target-binding proteins for our partners’ drug development efforts. At the heart of the OmniAb platform is what we call Biological Intelligence™, which powers the immune systems of our proprietary, engineered transgenic animals to create optimized antibody candidates for human therapeutics. We believe the OmniAb animals comprise the most diverse host systems available in the industry. These technologies paired with xPloration, our AI-powered high-throughput single B-cell screening platform, are used to identify fully-human antibodies with exceptional performance and developability characteristics. We provide our partners both integrated end-to-end capabilities and highly customizable offerings, which address critical industry challenges and provide optimized discovery solutions. Our business model aligns scientific and economic interests of our partners through structured agreements that generally include upfront/access fees, service revenue, milestones and royalties on commercial sales.
For more information, please visit www.omniab.com.
Forward-Looking Statements
OmniAb cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” and similar expressions, are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: statements regarding the value of our portfolio and growth prospects of our business; the ability to add new partners and programs; the ability to efficiently leverage and expand the reach of our technologies; continuation of our innovation efforts and the expected value and performance of our technologies and the opportunities they may create, potential contributions to our business by our xPloration partner access program; scientific presentations and clinical and regulatory events of our partners and the timing thereof and their perspectives on and expectations for their product candidates; and our 2026 financial guidance. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: our future operating results and success is dependent on acceptance of our technology platform and technologies by new and existing partners, as well as on the eventual development, approval and commercialization of products developed by our partners for which we have no control over the development plan, regulatory strategy or commercialization efforts; biopharmaceutical development is inherently uncertain; risks arising from changes in technology; the competitive environment in the life sciences and biotechnology platform market; risks associated with quality and timing in manufacturing our xPloration instruments and related consumables and our reliance on a limited number of third-party manufacturers and suppliers; our failure to maintain, protect and defend our intellectual property rights; difficulties with performance of third parties we will rely on for our business; government healthcare reform, legislative measures and regulatory developments in the United States and foreign countries; unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price; the potential impact of tariffs, trade policies, geopolitical instability and conflicts, inflation and interest rate changes; we may not achieve our financial guidance; our operating expenses may be higher than we anticipate, including if we decide to engage in activities not currently in our plan or if we face unexpected, or higher than anticipated, expenses; we may use our capital resources sooner than we expect; and other risks described in our prior press releases and filings with the SEC, including under the heading “Risk Factors” in our annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Partner Information
The information in this press release regarding partnered products and programs comes from information publicly released by our partners.
Note Regarding Use of Non-GAAP Financial Measure
This press release includes financial results prepared in accordance with accounting principles generally accepted in the United States (GAAP), and also actual and projected cash costs and operating expenses, which is a non-GAAP financial measure, adjusted to exclude share-based compensation, depreciation and amortization of intangibles. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, OmniAb believes the presentation of actual and projected non-GAAP cash costs and operating expenses, when viewed in conjunction with GAAP figures, provides investors with a more meaningful understanding of our operating performance. Cash costs and operating expense is not intended to be considered in isolation or as a substitute for costs and operating expenses. A reconciliation between actual and projected GAAP costs and operating expenses and non-GAAP costs and operating expenses is provided later in this press release.
OMNIAB, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share data)
June 30, 2026
December 31, 2025
(Unaudited)
ASSETS
Current assets:
Cash and cash equivalents
$
24,336
$
25,524
Short-term investments
27,659
28,501
Accounts receivable, net
10,328
7,390
Prepaid expenses and other current assets
3,690
3,926
Total current assets
66,013
65,341
Intangible assets, net
116,068
125,149
Goodwill
83,979
83,979
Property and equipment, net
8,475
9,428
Operating lease right-of-use assets
14,461
15,545
Restricted cash
560
560
Other long-term assets
701
912
Total assets
$
290,257
$
300,914
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable
$
2,088
$
1,879
Accrued expenses and other current liabilities
4,499
6,291
Current contingent liabilities
940
1,044
Current deferred revenue
2,258
3,161
Current operating lease liabilities
3,973
3,879
Total current liabilities
13,758
16,254
Long-term contingent liabilities
25
315
Deferred income taxes, net
882
785
Long-term operating lease liabilities
14,940
16,455
Long-term deferred revenue
309
—
Other long-term liabilities
69
78
Total liabilities
29,983
33,887
Stockholders' equity:
Preferred stock, $0.0001 par value; 100,000,000 shares authorized at June 30, 2026 and December 31, 2025; no shares issued and outstanding at June 30, 2026 and December 31, 2025
—
—
Common stock, $0.0001 par value; 1,000,000,000 shares authorized at June 30, 2026 and December 31, 2025; 145,390,398 and 144,308,383 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively
15
14
Additional paid-in capital
440,024
433,180
Accumulated other comprehensive income (loss)
(20
)
12
Accumulated deficit
(179,745
)
(166,179
)
Total stockholders’ equity
260,274
267,027
Total liabilities and stockholders’ equity
$
290,257
$
300,914
OMNIAB, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data)
Three Months Ended June 30,
Six Months Ended June 30,
2026
2025
2026
2025
Revenue:
License and milestone revenue
$
9,515
$
1,242
$
21,540
$
3,263
Service revenue
2,473
1,936
4,580
3,839
xPloration revenue
1,161
608
1,215
650
Royalty revenue
266
111
507
299
Total revenue
13,415
3,897
27,842
8,051
Costs and operating expenses:
Cost of xPloration revenue
610
262
625
265
Research and development
9,586
10,864
19,226
23,466
General and administrative
6,653
7,684
13,272
15,599
Amortization of intangibles
3,053
3,228
9,081
6,456
Other operating expense (income), net
150
(1,922
)
104
(2,672
)
Total costs and operating expenses
20,052
20,116
42,308
43,114
Loss from operations
(6,637
)
(16,219
)
(14,466
)
(35,063
)
Other income (expense), net:
Interest income
434
436
921
973
Other income (expense), net
(9
)
27
68
28
Total other income, net
425
463
989
1,001
Loss before income taxes
(6,212
)
(15,756
)
(13,477
)
(34,062
)
Income tax benefit (expense)
353
(119
)
(89
)
(13
)
Net loss
$
(5,859
)
$
(15,875
)
$
(13,566
)
$
(34,075
)
Net loss per share, basic and diluted
$
(0.05
)
$
(0.15
)
$
(0.11
)
$
(0.32
)
Weighted-average shares outstanding, basic and diluted
128,795
106,148
128,521
105,886
OMNIAB, INC. RECONCILIATION OF GAAP COSTS AND OPERATING EXPENSES TO NON-GAAP CASH COSTS AND OPERATING EXPENSES
Three Months Ended June 30,
Six Months Ended June 30,
(in thousands)
2026
2025
2026
2025
Costs and operating expenses (GAAP)
$
20,052
$
20,116
$
42,308
$
43,114
Less: Depreciation of property and equipment
577
864
1,183
1,830
Less: Amortization of intangible assets
3,053
3,228
9,081
6,456
Less: Share-based compensation
3,159
4,111
6,499
8,255
Cash costs and operating expenses (Non-GAAP)
$
13,263
$
11,913
$
25,545
$
26,573
(in millions)
2026 Forecast
Costs and operating expenses (GAAP)
$84 to $88
Less: Depreciation and amortization
18
Less: Share-based compensation
15
Cash costs and operating expenses (Non-GAAP)
$51 to $55
OmniAb, Inc. investors@OmniAb.com X@OmniAbTech Alliance Advisors IR Vivian Cervantes vcervantes@allianceadvisors.com (973) 873-7724
临床1期临床2期临床结果财报临床3期
2026-07-13
·拾辉手记
—— 当“仿制药”逻辑遇上生物药
“
同样的治疗效果 ，几分之一的价格。这可能是近年医药领域里， 对普通人钱包影响最大 ，却最不被了解的一项政策红利。
阿达木单抗（商品名 Humira，中文修美乐），曾经是蝉联多年的“全球药王”——年销售额峰值超过 210 亿美元 。
但在 2023 年，它的美国核心专利到期了。随后，十几个生物类似药如潮水般涌入市场。几个月内，这些“仿制版”的批发价直接跌到了原研药的 15%-20% ，相当于打了 1.5 到 2 折。
更夸张的是，勃林格殷格翰（Boehringer Ingelheim）和 GoodRx 在 2024 年推出了一项患者援助计划，将一款阿达木单抗生物类似药以 92% 的折扣提供给符合条件的患者——原研药每月约 2100 美元，生物类似药只需一百多美元。
同样的治疗效果，几分之一的价格。
但很多患者，甚至不少医生，都还不知道它们的存在。
📌 本文看点
01
生物类似药是什么？和仿制药有何不同
02
实际降价幅度有多大？
03
为什么便宜却未被广泛使用？
01
WHAT IS BIOSIMILAR先搞清楚：什么是“生物类似药”？
化学仿制药大家比较熟悉——比如布洛芬、二甲双胍，原研专利到期后，其他厂家用完全相同的化学分子式就能生产出“仿制药”，成分和原研药一模一样。
但 生物药完全是另一回事 。
抗体类药物是由 活细胞 （比如常用的 CHO 细胞）“养”出来的蛋白质大分子。它的分子量是普通化学药的 上千倍 ，分子结构也要复杂得多。打个比方：如果化学药是一把简单的钥匙，那抗体药就是一台精密的机械手表——你很难凭空复制出一块完全相同的手表。
「所以，生物药做不到“一模一样”的仿制。」
正因为如此，监管机构专门发明了一个概念—— 生物类似药（Biosimilar） ：它不需要和原研药“完全相同”，只需要通过大量对比试验，证明在质量、安全性和有效性上高度相似（highly similar），在临床上 “没有有意义的差异”，就可以获批。
这是一个务实的标准——不是“100% 复制”，而是“足够接近，疗效和安全等价”。
而这个“足够接近”的门槛，由 FDA（美国药监局）、EMA（欧洲药监局）、NMPA（中国国家药监局） 等监管机构严格把关，需要经过层层的结构分析、动物实验和临床验证。
02
PRICE DROP生物类似药到底能便宜多少？
根据 FDA 2024 年的年度报告， 生物药虽然只占美国处方量的 5%，却占了药品总支出的 51% 。也就是说，一半以上的药费，花在了极少数的生物药上。
这正是生物类似药的价值所在——只要把这一小部分高价药的价格打下来，就能省下巨额的医保资金和患者支出。
实际降价幅度确实惊人：
阿达木单抗（修美乐）
批发价折扣迅速超过 80%，部分患者援助项目折扣达 85%-92%
利妥昔单抗（美罗华）
平均售价折扣约 77%
贝伐珠单抗（安维汀）
平均售价折扣约 60%
曲妥珠单抗（赫赛汀）
平均售价折扣约 54%
4670亿$
2024年美国仿制药+生物类似药为医疗系统节省金额
6000-24000
中国患者每月可节省金额（人民币/元）
根据美国可及药品协会（AAM）与 IQVIA 的报告， 2024 年美国仿制药和生物类似药合计为医疗系统节省了超过 4670 亿美元 ，其中生物类似药的贡献占比逐年快速提升。
在中国，根据 2025 年发表在 *Frontiers in Public Health* 上的研究，阿达木单抗、英夫利西单抗、托珠单抗这几款药物的生物类似药， 每月可为每位患者节省约 6000-24000 元人民币 ，相当于中国居民人均月可支配收入的数倍。
03
GLOBAL APPROVALS全球批准了多少个生物类似药？
92
FDA 累计批准生物类似药数量（截至2026.3）
57
NMPA 批准生物类似药数量（2019-2025.4）
FDA 自 2015 年批准第一个生物类似药以来，截至 2026 年 3 月已累计批准 92 个 ，覆盖 20 种原研生物药。其中仅 2024 年一年就批准了创纪录的 18 个 ，为历年之最。
中国方面，根据 2025 年《中国药学杂志》的分析， 2019 年至 2025 年 4 月，NMPA 共批准 57 个生物类似药 ，覆盖 7 个治疗领域，平均审批时间约 1.4 年。
获批数量在快速增长，但 市场渗透率远远跟不上审批速度 。
<20%
美国市场份额
118
未来十年将失去专利保护的生物药
2340亿$
对应市场规模
根据 FDA 引用的数据，已获批的生物类似药在美国市场的份额仍低于 20%。更值得关注的是，未来十年将有 118 种生物药失去专利保护，对应约 2340 亿美元的市场规模，但目前只有其中 12 种有生物类似药在开发中 。
「大量生物药专利到期后，却没有“平价替代版”跟进——这就是行业所说的“生物类似药真空”。」
04
BARRIERS为什么便宜却没有被广泛使用？
原因比较复杂，核心有以下几点：
1. 医生和患者的认知惯性
很多人本能地觉得“不是原研的就不放心”，担心“便宜没好货”。
但 FDA、EMA 和 NMPA 都明确表态： 获批的生物类似药在安全性和有效性上，与原研药没有临床意义上的差异。 这不是“差不多就行”，而是监管机构经过一整套严格的对比验证后给出的官方结论。
2. 专利壁垒和“专利丛林”
原研药企通常会在核心专利之外，布局大量外围专利——制造工艺专利、配方专利、适应症专利、给药装置专利等等。哪怕核心专利到期了，后续的一堆专利仍然可以阻挡生物类似药上市。
阿达木单抗当年的专利布局，就被业内戏称为 “专利长城” 。
3. “可互换”认证门槛高
在美国，生物类似药如果获得“可互换（interchangeable）”认证，药师可以不经医生重新开处方，直接用生物类似药替换原研药——这对市场渗透至关重要。但截至 2025 年，获得这一认证的 产品仍然非常有限 。
4. 中间环节的定价扭曲
PBM（药品福利管理机构）和保险公司的复杂定价机制，有时反而让便宜的生物类似药，在患者自付层面并不比原研药划算—— 中间的差价被流通环节吃掉了 。
05
POLICY SHIFT2025 年政策转向：FDA 要加速审批了
2025 年 10 月，FDA 发布了一份可能改变行业格局的指导草案： 在分析数据足够充分的前提下，允许生物类似药豁免 III 期比较性临床试验 。
FDA 专员 Marty Makary 在发布会上表示，这一政策 有望将生物类似药的开发周期缩短 3-4 年 。
这意味着：开发生物类似药的时间成本和资金成本将进一步下降，更多企业有能力参与竞争——最终受益的，是支付更低药费的患者和整个医保系统。
∞
THE END写在最后
生物类似药可能是近年医药领域里， 对普通人钱包影响最大、却最不被了解的一项政策红利 。
同样的治疗效果，一半甚至更低的价格。FDA、EMA、NMPA 三大监管机构都替你把过关了。但它在美国的市场份额还不到 20%，大量患者仍在为昂贵的原研药买单。
下次如果医生给你开了一款生物药，不妨多问一句：
「有没有生物类似药可以替代？」
这一句话，可能帮你省下一大笔钱。
END
数据来源：FDA New Drug Therapy Annual Report 2024 | AAM/IQVIA Savings Report 2025 | Samsung Bioepis Biosimilar Market Report Q2 2026 | Frontiers in Public Health, 2025 | 中国药学杂志, 2025
声明：本文为科普性质，所有数据均来自 FDA、NMPA、IQVIA 等权威机构的公开报告和同行评审文献。不构成任何用药建议，具体用药方案请遵医嘱。
如果你觉得今天这篇有收获，欢迎 点赞、在看、转发 三连，我们下篇见。
2026-05-29
·星狐说药
引言与背景：JAK/STAT通路的靶点演进与核心命题
在过去的二十年中，Janus激酶/信号转导及转录激活因子（JAK/STAT）通路的治疗性干预代表了免疫介导炎症性疾病（IMID）和肿瘤学领域最重大的药理学突破之一。多个泛JAK（pan-JAK）抑制剂和选择性JAK抑制剂（如托法替布、巴瑞替尼、乌帕替尼、阿布昔替尼等）的获批，充分验证了该通路在细胞因子信号传导中的核心地位 1。
然而，早期药物设计的核心前提——即“靶向最上游的激酶节点能够提供最有效、最全面的治疗干预”——在长期的临床实践中被证明是一把双刃剑。虽然上游的JAK抑制剂能够高效地扑灭致病性细胞因子信号，但它们同时也会破坏对维持生命至关重要的生理性网络。这一动态促使生物制药界发生了一场深刻的范式转变：研究焦点正从上游激酶（JAKs）急剧向下游转录因子（STATs）转移。
历史上，由于STAT蛋白缺乏传统的酶活性口袋，它们一直被业界归类为“不可成药”（undruggable）靶点 3。但随着靶向蛋白降解技术（TPD，特别是PROTACs）以及高度特异性的Src同源2（SH2）结构域别构和正构抑制剂的成熟，STAT3和STAT6正在成为临床开发的热点 5。针对“靶向JAK理论上比靶向STAT更强，做STAT抑制剂的意义何在？”这一核心疑问，本报告将通过深度剖析JAK抑制剂的安全性困境、STAT蛋白的生物学特异性、转录因子的成药性突破，以及详实的临床概念验证（PoC）数据，全面评估STAT6和STAT3靶点的立项前景。
核心科学假设的解构：为什么“上游更强”是一个临床伪命题？
要理解开发STAT3和STAT6抑制剂的战略必然性，首先必须解构JAK/STAT信号级联的生物学架构，以及对其进行广泛药理学抑制所带来的临床后果。人类蛋白质组包含四种不同的Janus激酶（JAK1、JAK2、JAK3和TYK2）和七种STAT蛋白（STAT1、STAT2、STAT3、STAT4、STAT5a、STAT5b和STAT6） 8。细胞表面的细胞因子受体缺乏内在的激酶活性，因此它们依赖于结合的JAK激酶在配体结合时相互交叉磷酸化并磷酸化受体。这种磷酸化为细胞质中特定STAT蛋白的SH2结构域创建了对接位点。一旦被招募，STATs被JAKs磷酸化，促使它们二聚化、易位至细胞核，并启动靶基因的转录 2。
靶向JAK的理论优势在于其位置的“收敛性”。单个JAK异构体通常服务于多个细胞因子受体的下游。例如，JAK1与各种其他JAK配对，介导来自大量白细胞介素和干扰素的信号 2。因此，泛JAK抑制剂甚至具有一定选择性的JAK抑制剂在免疫系统中起到了“大锤”的作用，能够同时沉默广泛的细胞因子通路 1。虽然这在多种自身免疫性疾病中产生了强大的疗效，但它不可避免地带来了严重的脱靶（或夸大的在靶）安全性负债。
这种广谱阻断的临床表现是美国食品药品监督管理局（FDA）在对ORAL Surveillance安全性试验和其他药物警戒研究的数据进行审查后，强制要求对整个JAK抑制剂类别（包括托法替布、巴瑞替尼和乌帕替尼）添加严格的黑框警告 12。这些警告涵盖了重大心血管不良事件（MACE）、静脉血栓栓塞（VTE）、严重和机会性感染以及恶性肿瘤（包括非黑素瘤皮肤癌和淋巴瘤）的风险显著增加 12。
这些毒性反应的机制基础与被抑制的特定JAK节点的生物学功能有着内在的联系：
JAK2与造血功能： JAK2是造血过程的绝对核心，作为促红细胞生成素（EPO）、促血小板生成素（TPO）和粒细胞-巨噬细胞集落刺激因子（GM-CSF）的专性信号转导子 9。不可避免地交叉抑制JAK2会导致贫血、中性粒细胞减少和血小板减少症 1。
JAK1/JAK3与免疫稳态： JAK1和JAK3协调共同γ链细胞因子（IL-2、IL-7、IL-15）的信号传导，这些细胞因子对于基础淋巴细胞稳态、自然杀伤（NK）细胞的发育以及正常的免疫监视是绝对必需的 9。抑制这些通路会使患者容易发生严重的病毒重新激活（如带状疱疹），并削弱免疫系统检测和清除早期恶性肿瘤的能力 12。
因此，“靶向上游在理论上更强”这一假设误解了现代慢性病管理的最终目标。上游靶向确实“更强”，但它是“不加区分的强”。在当代免疫学和靶向肿瘤学中，目标不再是最大程度的全身抑制，而是通路特异性的精准消融。
通过绕过JAK激酶并直接靶向其下游的STAT转录因子，治疗药物可以实现单一或特定细胞因子通路的精确控制 17。靶向STAT6可专门阻断白细胞介素-4（IL-4）和白细胞介素-13（IL-13）信号通路，这是2型（Th2）炎症的根本驱动因素，而完全不会干扰EPO/TPO通路或γ链细胞因子的免疫监视功能 3。同样，直接靶向STAT3能够干预Th17炎症轴和肿瘤介导的免疫逃逸，而不会诱发与上游JAK1/JAK2阻断相关的严重全血细胞减少症 8。归根结底，开发STAT6或STAT3抑制剂的根本意义在于：以小分子的形式提供类似生物制剂（单抗）的精准疗效和选择性，从根本上扩大治疗窗口，并规避困扰JAK抑制剂类的黑框安全隐患。
跨越“不可成药”鸿沟：转录因子靶向技术的底层突破
尽管靶向STAT蛋白的生物学和临床逻辑极具说服力，但由于转录因子构成了巨大的结构挑战，生物制药行业在过去几十年中在这一领域面临了严重的研发损耗。在人类蛋白质组的大约20,500种蛋白质中，绝大多数成功的药物靶向的是膜受体、离子通道或具有深层、明确疏水结合口袋的酶（如激酶的ATP结合位点） 4。
像STAT3和STAT6这样的转录因子主要在没有经典酶促活性位点的情况下发挥作用 3。它们的功能完全依赖于蛋白质-蛋白质相互作用（PPI）和蛋白质-DNA相互作用。介导这些相互作用的界面通常较大、平坦且高度带电 21。STAT蛋白的关键“阿喀琉斯之踵”是高度保守的SH2结构域，这是一个约由100个氨基酸组成的模块，负责结合磷酸酪氨酸基序 17。虽然SH2结构域对于STAT招募到细胞因子受体和随后的二聚化至关重要，但它们呈现出浅而高度极性的表面，传统的小分子极难与之进行高亲和力和高选择性的结合 17。早期对STAT3进行药物开发的尝试使用了拟肽或早期小分子，这些分子在细胞渗透性差、体内稳定性低和靶点占有率不足等方面举步维艰，导致了后期临床试验的大量失败 21。
目前STAT靶向药物迎来的复兴，极大地提升了这些项目的商业前景，这主要归功于两种截然不同的化学分子形态的成熟：靶向蛋白降解（TPD）技术和先进的、计算机辅助设计的SH2别构/正构抑制剂 4。
靶向蛋白降解技术，主要通过蛋白水解靶向嵌合体（PROTACs）实现，完全规避了抑制剂需要阻断功能位点的需求 26。PROTAC是一种异双功能分子，包含一个结合靶蛋白的配体（即使在非功能位点具有中等亲和力即可），通过连接子连接到另一个招募E3泛素连接酶（如VHL、CRBN或IAP）的配体 5。这种诱导的邻近效应导致STAT蛋白的多泛素化，将其标记为由细胞天然的泛素-蛋白酶体系统（UPS）进行快速降解 26。由于PROTAC以催化方式发挥作用——单个PROTAC分子可以编排多个靶蛋白的降解——与占位驱动的传统抑制剂相比，它们需要更低的全身暴露量 26。此外，通过消除整个STAT蛋白，PROTAC同时废除了其所有功能，包括支架功能和非激酶依赖性活性，从而确保了通路的彻底关闭 6。
与此同时，虚拟筛选、人工智能辅助药物设计以及基于结构的药物化学的进步，催生了新一代能够高亲和力结合STAT SH2结构域的传统小分子 3。利用这些平台的公司绘制了以前未被识别的隐秘口袋和SH2结构域的动态构象状态，从而创造出强效、持久和选择性的正构抑制剂，这些抑制剂不需要降解蛋白，而是物理性地阻断STAT激活所需的蛋白质-蛋白质相互作用 17。STAT6立项前景与临床PoC深度剖析：打造“口服版度普利尤单抗”
在当代的免疫学药物研发格局中，靶向STAT6的临床和商业前景无疑是最高的之一。STAT6是白细胞介素-4（IL-4）和白细胞介素-13（IL-13）的II型细胞因子受体下游的专性转录因子 18。这一特定的信号轴代表了驱动2型（Th2）辅助T细胞炎症的主调节网络，而Th2炎症是高度普遍的过敏性和特应性疾病的病理生理学基石，这些疾病包括特应性皮炎（AD）、哮喘、伴有鼻息肉的慢性鼻鼻窦炎（CRSwNP）、嗜酸性食管炎（EoE）、慢性自发性荨麻疹（CSU）和结节性痒疹（PN）等 18。
这一特定通路的商业可行性已经被单克隆抗体度普利尤单抗（Dupilumab，商品名Dupixent）毫无争议地验证，该药物通过结合共享的IL-4Rα亚基来阻断IL-4和IL-13信号传导。度普利尤单抗在这些适应症中取得了变革性的临床效果，创造了数十亿美元的商业成功，并确立了Th2疾病管理的黄金标准 18。然而，度普利尤单抗和新兴的竞争性生物制剂（如Tralokinumab、Lebrikizumab）存在不可忽视的临床痛点：它们需要终身皮下注射，存在冷链储存的物流负担，在致密纤维化环境中面临组织穿透性挑战，并且具有特定的免疫原性风险 19。
此外，度普利尤单抗在临床应用中面临一个特异性的严重副作用：度普利尤单抗诱导的眼表疾病（DIOSD，主要表现为严重的结膜炎）。大量临床研究表明，在接受度普利尤单抗治疗的特应性皮炎患者中，结膜炎的发生率极高 31。DIOSD的发病机制主要包括：IL-4Rα阻断导致结膜杯状细胞缺失和MUC5AC黏蛋白生成减少，引起泪膜不稳；同时阻断Th2信号后，引发局部免疫向Th1/Th17型炎症偏移，导致结膜、眼睑缘和角膜的炎症失控 31。
在此背景下，生物制药界针对STAT6开发的底层逻辑是打造“口服版的度普利尤单抗”。如果一种口服小分子能够完全消除STAT6的活性，它将提供媲美生物制剂的深层疗效，同时具备口服治疗的极大便利性和可及性 19。更重要的是，通过细胞内特异性降解或抑制STAT6，有望避开受体层面的负反馈机制，从而规避结膜炎这一严重的副作用 37。临床PoC的决定性证据：Kymera KT-621的突破
支持STAT6靶向临床可行性的最先进、最坚实的证据来自Kymera Therapeutics，该公司已将首创的（first-in-class）口服STAT6 PROTAC降解剂KT-621推进至人体试验阶段 30。KT-621的临床前数据显示了皮摩尔级别的效力，在所有相关的人类细胞背景中对IL-4/IL-13通路的体外抑制能力优于度普利尤单抗，并且在特应性皮炎和哮喘的多种小鼠模型中表现出与度普利尤单抗相当或更优的体内疗效 39。
STAT6降解的临床概念验证（PoC）极其可靠，这得益于最近公布的Phase 1健康志愿者试验和在患有中度至重度特应性皮炎的患者中进行的Phase 1b BroADen试验的数据。在健康志愿者的递增剂量研究（NCT06673667）中，KT-621在极低的剂量下（大于1.5 mg）即可在外周血单核细胞（PBMCs）中实现近乎完全（>90%）的STAT6蛋白降解，并在较高剂量下实现了血液和皮肤组织中STAT6蛋白的完全消除 35。
这一转化医学的势头在2026年美国皮肤病学会（AAD）年会上得到了进一步证实，Kymera在会上公布了Phase 1b BroADen试验的数据 42。在一个包含22名中度至重度特应性皮炎患者的队列中，每日口服KT-621（100 mg和200 mg剂量组）治疗28天后，外周血中位STAT6降解率达到98%，皮损部位的中位STAT6降解率达到94%。如此深度的靶点降解直接转化为对2型炎症生物标志物（包括TARC、Eotaxin-3、IL-31和IgE）的深度抑制 35。
BroADen试验的临床疗效终点提供了决定性的PoC证据。仅仅经过28天的治疗，患者的湿疹面积及严重程度指数（EASI）总体平均降低了63%，受累体表面积（BSA）减少了49%，峰值瘙痒数字评定量表（NRS）分数降低了40% 35。值得注意的是，29%的患者实现了EASI-75（即症状改善75%），并且患者主观评估的疾病严重程度（POEM）记录了具有临床意义的9分下降 44。考虑到生物疗法（如单抗）通常需要12至16周才能达到峰值疗效，在第4周实现63%的EASI降低，表明KT-621具有极其迅速的起效时间，这很可能是由小分子的高效组织穿透性与PROTAC降解过程的催化性质共同驱动的 35。
至关重要的是，KT-621的安全性特征验证了STAT6下游靶向的理论优势。该药物总体耐受性良好，没有严重的副作用（SAEs），没有导致停药的治疗相关不良事件，也没有出现临床相关的生命体征、实验室检测或心电图异常 37。更具有战略意义的是，在试验期间未观察到结膜炎、疱疹感染或关节痛的发生 37。初步的结膜炎缺失表明，细胞内STAT6降解确实可能绕过导致DIOSD的眼表负反馈循环，或者具备保留眼部杯状细胞的特殊组织分布动力学。如果这种安全性差异在正在进行的针对特应性皮炎的Phase 2b BROADEN2和针对嗜酸性哮喘的BREADTH试验中得以保持并获得统计学验证，STAT6降解剂将迅速取代生物制剂成为新的标准治疗方案 38。竞争格局与全球商业拓展 (BD) 动态
KT-621所提供的临床PoC已经引发了业界激烈的竞争活动，巩固了该靶点巨大的商业前景。截至2026年初，全球管线分析显示，大约有39个针对STAT6的开发项目，涵盖了PROTAC、正构抑制剂以及RNA/基因疗法 36。在这一领域中，大型跨国制药公司正展现出明显的战略转型：从内部开发传统的激酶抑制剂转向对靶向蛋白降解和新型SH2抑制机制的外部资产进行战略性收购和授权合作（License-in） 36。
在抑制剂领域，Recludix Pharma推进了REX-8756（SAR448755），这是一种首创的、高强效、高选择性、可逆的STAT6 SH2结构域正构小分子抑制剂 29。与Kymera的PROTAC不同，REX-8756通过占位驱动的抑制起作用，而不诱导蛋白质降解 19。在研究皮肤病学会（SID）年会上展示的临床前数据表明，在特应性皮炎和急性肺部炎症模型中，REX-8756实现了与靶向IL-4/IL-13通路的单克隆抗体相媲美的生物制剂级疗效 29。敏锐地认识到该资产的巨大潜力，度普利尤单抗的制造商赛诺菲（Sanofi）迅速与Recludix达成了价值数亿美元里程碑付款的战略合作，以确保无论最终哪种分子形态（降解剂或抑制剂）胜出，赛诺菲都能维持其在Th2炎症市场的绝对主导地位 19。REX-8756目前正在进行包含单次和多次递增剂量队列的Phase 1健康志愿者研究，其人体安全性及药代动力学数据将很快揭晓 19。
吉利德科学（Gilead Sciences）同样通过大手笔的商业拓展进入了STAT6竞技场。在2025年，Gilead与LEO Pharma达成了一项高达1.7亿美元的战略合作伙伴关系，获得了LEO Pharma处于临床前阶段的口服STAT6小分子抑制剂和靶向蛋白降解剂组合的全球权利 51。Gilead此举意在将其在自身免疫领域的布局从原本的JAK1抑制剂（Filgotinib）大幅扩展，构建下一代安全性更优的口服产品线。
辉瑞（Pfizer）则凭借其强大的内部研发实力，将其内部研发的STAT6抑制剂PF-08049820推进至针对特应性皮炎的Phase 1临床试验，目前正在评估不同剂型及食物效应对健康成人药代动力学（PK）和药效学（PD）的影响 56。同时，中国本土的生物技术公司也展现了卓越的全球竞争力，例如益方生物（InventisBio）已成功开发出临床前口服STAT6降解剂YF057，凸显了全球对这一靶点的战略聚焦 60。
对当前39个STAT6项目的深入分析也揭示了一个重大的市场空白（White Space）：目前65%的项目专注于口服给药，力图实现“口服度普利尤单抗”的效用，但纯粹的局部外用（Topical）给药方法却几乎完全缺失 36。考虑到某些特异性SH2抑制剂的分子量可能远低于双功能PROTAC分子，开发局部外用的STAT6疗法有望彻底打开庞大的轻至中度特应性皮炎市场，在病灶局部提供极其强大的Th2抑制，同时实现零全身暴露，从而将安全性提升至极致水平。
公司
资产
分子形态
核心适应症
开发阶段
PoC亮点
Kymera
KT-621
PROTAC 降解剂
特应性皮炎, 哮喘
Phase 2b
血液降解率98%；28天EASI评分下降63%；未观察到结膜炎副作用 37。
Recludix / Sanofi
REX-8756 (SAR448755)
SH2 正构抑制剂
Th2型炎症
Phase 1
已完成首例人体给药；赛诺菲高额里程碑合作买断；临床前效力媲美单抗 48。
LEO Pharma / Gilead
多资产组合
抑制剂与降解剂
自身免疫疾病
临床前
Gilead高达17亿美元重金收购，显示对靶点的绝对信心 52。
Pfizer (辉瑞)
PF-08049820
小分子抑制剂
特应性皮炎
Phase 1
正在进行密集的不同剂型（速释/缓释）健康志愿者人体试验 56。
InventisBio (益方生物)
YF057
PROTAC 降解剂
特应性皮炎, 哮喘
临床前
中国创新药企的代表性布局，展现了该靶点在全球视角的火热程度 60。STAT3立项前景与临床PoC深度剖析：重塑肿瘤免疫微环境与抑制Th17自身免疫
虽然STAT6是过敏免疫学中无可争议的主调节器，但STAT3呈现出更为复杂、双面性的生物学特征。STAT3在多个细胞因子家族（特别是IL-6家族、IL-10、IL-21和IL-23）的下游运作 16。它不仅在驱动Th17介导的自身免疫发病机制（如银屑病和炎症性肠病）中起根本作用，更为关键的是，它在策划实体瘤和血液恶性肿瘤的存活、转移和免疫逃避中发挥了至高无上的主导作用 2。STAT3在肿瘤免疫微环境 (TME) 中的“架构师”角色
在肿瘤学中开发STAT3抑制剂的理论基础异常坚实。在近70%的人类癌症中，STAT3呈现持续性的过度激活状态，这要么是因为功能获得性突变，要么是持续的上游信号传导（例如升高的IL-6），抑或是负反馈机制的丧失（例如SOCS蛋白的沉默） 21。STAT3不仅仅通过上调Oct4和Sox2维持癌症的干细胞特性，通过诱导VEGF促进血管生成，它如今被广泛认为是免疫抑制性肿瘤微环境（TME）的“总架构师” 8。
在TME中，肿瘤衍生的因子在浸润的免疫细胞内持续激活STAT3。这种激活通过多个交叉机制系统性地瘫痪了抗肿瘤免疫：
MDSC扩张与激活： STAT3驱动髓源性抑制细胞（MDSCs）的病理性扩张。它上调MDSCs内的NOX2组件，驱动活性氧（ROS）的释放，从而直接抑制细胞毒性T淋巴细胞（CTL）的反应 65。在缺乏STAT3介导的NOX2活性的情况下，MDSC会丧失抑制能力并分化为成熟的树突状细胞。
Treg诱导： 激活的STAT3会上调IL-10和TGF-β的分泌，这进一步促进了表达FoxP3的调节性T细胞（Tregs）的极化和抑制活性，进一步冻结了效应T细胞的杀伤力 64。
巨噬细胞极化： STAT3对于肿瘤相关巨噬细胞（TAMs）向促肿瘤、免疫抑制的M2表型分化至关重要，它抑制了IL-12的产生并下调了抗原呈递能力（如MHC-II和CD80/CD86的表达） 66。
免疫检查点上调： STAT3直接上调肿瘤细胞和周围髓系细胞上程序性死亡配体1（PD-L1）和吲哚胺2,3-双加氧酶1（IDO1）的表达，巩固了抵御T细胞攻击的免疫盾牌 64。
鉴于这种巨大的生物学影响，STAT3抑制剂在理论上具备了同时攻击内在肿瘤生长和逆转免疫排斥的能力，即能够将“冷”肿瘤转化为“热”肿瘤，使其容易被内源性免疫系统清除，或者与标准的抗PD-1/PD-L1检查点抑制剂产生强大的协同作用 65。STAT3抑制剂的研发阵痛与经验教训
将STAT3的优异生物学理论转化为临床疗效在历史上是一条充满荆棘的道路。第一代STAT3抑制剂（如OPB-31121和Napabucasin）以及针对SH2结构域或DNA结合结构域的早期小分子，在Phase I和Phase III试验中遭遇了极高的损耗率 24。回顾性分析表明，试验证明的低效和高退市率主要源于这些早期分子存在严重的缺陷：极差的生物利用度、缺乏持续的靶点占有率、以及由于分子特异性不足导致的严重脱靶毒性，这些因素共同造成了高度不利的疗效-安全性不平衡 24。反义寡核苷酸（ASO）药物Danvatirsen（AZD9150）在与PD-L1抑制剂Durvalumab的联合用药中展现了一定潜力，但ASO的组织递送和脱靶问题依然是其广泛应用的障碍 71。第二代STAT3抑制剂的临床PoC证据：Tvardi TTI-101与Kymera KT-333
然而，利用现代药物设计技术的第二代药物最近取得了坚实的临床PoC。Tvardi Therapeutics开发了TTI-101，这是一种具有口服生物利用度、直接针对STAT3 SH2结构域的小分子抑制剂 4。利用先进的虚拟配体筛选技术和结构精细化的STAT3核心模型，TTI-101克服了SH2结合的难题。在一项涵盖复发/难治性晚期实体瘤的Phase 1单药治疗试验（NCT03195699）中，TTI-101展示了明确的抗肿瘤活性和出色的耐受性 69。在41名可评估患者中，TTI-101诱导了12%的确认部分缓解（cPR）率和41%的疾病稳定（SD）率 74。特别是在经过大量预处理的肝细胞癌（HCC）患者中——一种深刻由STAT3介导的慢性炎症和纤维化驱动的恶性肿瘤——该药物实现了惊人的18% cPR率，中位治疗失败时间超过10个月 69。配对的肿瘤活检证实了磷酸酪氨酸-STAT3水平的显著降低，验证了其在靶作用机制 69。基于这些成功数据，Tvardi目前正在推进TTI-101在HCC（联合帕博利珠单抗或阿替利珠单抗/贝伐珠单抗）、转移性乳腺癌和特发性肺纤维化（IPF）的Phase 2试验 75。
同时，Kymera将其Pegasus PROTAC平台应用于STAT3，将KT-333推向了复发/难治性血液恶性肿瘤（包括T细胞淋巴瘤和大颗粒淋巴细胞白血病）以及实体瘤的Phase 1临床试验 27。KT-333展示了强大的靶点接合能力，在外周血单核细胞中实现了高达96%的平均最大STAT3降解 78。
KT-333的临床数据揭示了具有深远意义的疾病改变能力。在经过大量预处理的患者队列中，Kymera报告了一名霍奇金淋巴瘤患者的部分缓解，皮肤T细胞淋巴瘤（CTCL）患者中的多个部分缓解，以及一名携带STAT3突变的NK细胞淋巴瘤患者的完全缓解 78。在实体瘤中，包括胆管癌、肾细胞癌和头颈部肿瘤患者中实现了疾病稳定 79。
至关重要的是，KT-333的药效学特征证实了TME内预期的免疫调节作用。治疗导致肿瘤内STAT3及其负反馈调节因子SOCS3的大量降解，伴随着干扰素-γ（IFNγ）及IFNγ刺激基因的系统性诱导 78。这一分子标签表明了抗肿瘤免疫功能的成功启动，并为将STAT3降解剂与PD-1抑制剂联合使用提供了强有力的临床依据，因为消除STAT3驱动的免疫抑制在理论上会降低T细胞介导的细胞毒性门槛 69。
需要警惕的是，虽然KT-333总体耐受性良好，且主要是1/2级不良事件（如疲劳、恶心），但在较高剂量水平下观察到了诸如3级口腔炎和关节痛的剂量限制性毒性（DLTs） 79。这凸显了STAT6和STAT3之间一个根本的区别：虽然STAT6表现出高度受限的表达和功能特征（使其全身消除具有极高的耐受性），但STAT3是多种细胞类型使用的具有高度多效性的生存因子 24。因此，虽然STAT3抑制剂和降解剂代表了超越JAK抑制剂的巨大飞跃，但在将其扩展至慢性的、非肿瘤性自身免疫适应症（如银屑病或炎症性肠病）时，研发人员需要更加谨慎地评估剂量滴定，或探索下一代策略（例如招募肿瘤特异性E3泛素连接酶以实现靶向降解），以进一步拓宽治疗指数 24。
总结与立项建议
从抑制上游JAK向调节下游STAT的战略迁移，代表了合理药物设计领域的一次极其精密和深远的演进。通过直接靶向远端转录因子STAT3和STAT6，当代生物治疗药物正在精准切断疾病的病理节点，同时完好地保留由上游激酶调节的对生命至关重要的造血和基础免疫稳态生理回路。
支持这一重大转变的临床概念验证（PoC）不仅是坚实的，而且正在加速兑现：
STAT6项目的前景： 已经高度去风险化（De-risked）。KT-621等降解剂以及REX-8756等小分子抑制剂的数据毫无争议地证明了转录因子可以在体内被高效调控或清除，以方便的口服形式提供生物制剂级别的卓越疗效。更为重要的是，临床数据初步显示它能够规避困扰度普利尤单抗的眼表疾病（结膜炎）等特异性不良事件。从商业拓展（BD）的视角看，全球制药巨头正斥资数十亿美元跑马圈地，STAT6口服药物将在未来的Th2炎症市场中占据绝对主导地位，立项价值极高。由于纯局部外用制剂领域目前仍存在巨大的蓝海市场，具有针对性地开发外用STAT6抑制剂将是极具差异化竞争力的立项选择。
STAT3项目的前景： 正迎来肿瘤学领域的重生。由于第二代高选择性SH2结合剂（如TTI-101）和PROTAC（如KT-333）的出现，历史上面临巨大挫折的STAT3靶点正在重新焕发生机。这些药物成功地证明了它们能够瓦解由STAT3驱动的肿瘤微环境免疫抑制架构，在对传统免疫疗法无效的实体瘤和淋巴瘤中恢复抗肿瘤免疫并产生客观缓解。立项STAT3的重点应聚焦于难治性肿瘤以及与免疫检查点抑制剂的联合用药策略。对于进入慢性自身免疫领域的拓展，则需对其由于抑制正常组织STAT3生理功能可能带来的安全性边界进行高度谨慎的评估。
综上所述，STAT6和STAT3靶向药物的研发不再是处于高风险的平台验证期，而是已经步入了高度可预测的临床执行和价值兑现期。它们具备重塑数百亿美元治疗市场格局的分子基础和生物学潜力，标志着精准转录调控时代的全面到来。Works cited
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100 项与 贝伐珠单抗生物类似药(Boehringer) 相关的药物交易
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研发状态
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 转移性结直肠癌 | 临床3期 | 美国 | 2016-06-08 | |
| 转移性结直肠癌 | 临床3期 | 日本 | 2016-06-08 | |
| 转移性结直肠癌 | 临床3期 | 西班牙 | 2016-06-08 | |
| 转移性结直肠癌 | 临床3期 | 乌克兰 | 2016-06-08 | |
| 晚期非小细胞肺癌 | 临床3期 | 美国 | 2015-07-08 | |
| 晚期非小细胞肺癌 | 临床3期 | 日本 | 2015-07-08 | |
| 晚期非小细胞肺癌 | 临床3期 | 阿根廷 | 2015-07-08 | |
| 晚期非小细胞肺癌 | 临床3期 | 巴西 | 2015-07-08 | |
| 晚期非小细胞肺癌 | 临床3期 | 保加利亚 | 2015-07-08 | |
| 晚期非小细胞肺癌 | 临床3期 | 智利 | 2015-07-08 |
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临床结果
临床结果
适应症
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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3期 | 663 | Chemotherapy+BI 695502 | 獵窪獵壓簾顧膚糧鏇憲(鏇窪遞範膚淵艱鑰鹽鬱) = 艱繭糧壓憲蓋壓衊糧觸 憲憲顧醖鹽艱範鬱繭願 (網觸淵簾願鏇鬱鹹淵願 ) | 相似 | 2021-10-28 | ||
Chemotherapy+bevacizumab | 獵窪獵壓簾顧膚糧鏇憲(鏇窪遞範膚淵艱鑰鹽鬱) = 蓋範鬱廠蓋鹽窪顧鹽獵 憲憲顧醖鹽艱範鬱繭願 (網觸淵簾願鏇鬱鹹淵願 ) | ||||||
临床3期 | 671 | 構構襯餘範願顧鑰鹽鹹 = 網鑰觸鑰齋鑰鏇餘築鏇 網繭選艱繭齋鹹鹽獵積 (遞醖積膚蓋鬱遞淵網範, 齋鑰鹽襯構鬱製鑰夢齋 ~ 願觸鬱窪顧鬱壓製範鏇) 更多 | - | 2020-01-13 | |||
临床3期 | 123 | mFOLFOX6+BI 695502 | 獵淵蓋廠獵鬱網鹽衊齋 = 醖糧壓鹹築憲壓築遞壓 遞壓網醖積蓋網襯遞範 (範鑰餘襯壓鹽窪憲選齋, 遞鏇範憲蓋壓觸製鏇選 ~ 鹽艱鬱衊憲鏇構糧廠鏇) 更多 | - | 2019-11-21 | ||
临床1期 | - | 91 | (BI 695502 (T)) | 夢憲鹽範獵衊獵艱鬱網(觸獵膚艱糧鑰構製夢獵) = 鑰觸選壓蓋膚衊窪繭鹹 鹹繭鏇構選鹹鹽齋築選 (網鹽蓋繭蓋糧窪淵夢選, 19.52) 更多 | - | 2019-11-08 | |
(United States (US)-Licensed Avastin® (R1)) | 夢憲鹽範獵衊獵艱鬱網(觸獵膚艱糧鑰構製夢獵) = 繭憲網夢範鬱簾憲顧夢 鹹繭鏇構選鹹鹽齋築選 (網鹽蓋繭蓋糧窪淵夢選, 15.57) 更多 |
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