Regeneron Pharmaceuticals, Inc.

- Reports continued progress in the evaluation of assets for potential pipeline expansion in the areas of oncology and rare disease; transaction targeted for 2025 -- Provides updated and extended cash runway guidance into H1 2027 -- Management to host conference call today, August 14th , at 8:30 am EDT - TEL AVIV, Israel , Aug. 14, 2025 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a development stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, today reported its unaudited financial results for the quarter ended June 30, 2025 , and provided a corporate update. "Since our last quarterly update, we have been acutely focused on evaluating a broad range of potential pipeline expansion opportunities where we can leverage our clinical and regulatory expertise, and track record of drug approval success, to drive new innovation in areas of need," said Philip Serlin , Chief Executive Officer of BioLineRx . "Today, I am pleased to report that discussions with potential partners continue to progress. Our balance sheet is strong, our organization is lean, and we are seeing promising opportunities that fit well within our criteria - most notably a clear and efficient development pathway. I remain confident that we could potentially execute a transaction this year that will expand our pipeline and provide fresh opportunities for clinical success and long-term value creation." Financial Updates With $28.2 million on its balance sheet as of June 30, 2025 , BioLineRx is guiding to a cash runway into the first half of 2027. This represents an improvement as compared to the Company's previous cash runway guidance into the second half of 2026. Clinical Updates Motixafortide Pancreatic Ductal Adenocarcinoma (mPDAC) Enrollment activities continue in the CheMo4METPANC Phase 2b clinical trial, which is being led by Columbia University , and supported by both Regeneron and BioLineRx . The CheMo4METPANC trial is evaluating motixafortide in combination with the PD-1 inhibitor cemiplimab and standard chemotherapy (gemcitabine and nab-paclitaxel). A prespecified interim analysis is planned when 40% of progression-free survival (PFS) events are observed. An abstract featuring updated data from the pilot phase of the ongoing CheMo4METPANC clinical trial was presented at the 2025 ASCO Annual Meeting in May. Key highlights include: - Four of 11 patients remained progression-free after more than one year.- Two patients underwent definitive treatment for metastatic pancreatic cancer: one had complete resolution of all radiologically detected liver lesions and underwent radiation to the primary pancreatic tumor, and one had a sustained partial response and underwent pancreaticoduodenectomy with pathology demonstrating a complete response.- An analysis of pre- and on-treatment biopsies revealed that CD8+ T-cell tumor infiltration increased across all eleven patients treated with the motixafortide combination. Sickle Cell Disease (SCD) & Gene Therapy Ongoing Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease continues to progress. The trial is sponsored by Washington University School of Medicine in St. Louis , and results are anticipated in the second half of 2025. A second study, sponsored by St. Jude Children's Research Hospital , continues to enroll patients. The study is a multi-center Phase 1 clinical trial evaluating motixafortide for the mobilization of CD34+ hematopoietic stem cells (HSCs) used in the development of gene therapies for patients with Sickle Cell Disease (SCD). APHEXDA Performance Update APHEXDA generated sales of $1.7 million in the second quarter of 2025, providing royalty revenue to the Company of $0.3 million . Financial Results for the Quarter Ended June 30, 2025 Total revenues for the second quarter of 2025 were $0.3 million , reflecting the royalties paid by Ayrmid from the commercialization of APHEXDA in stem cell mobilization in the U.S. Total revenues in 2025 are not comparable to the same period in 2024, which included direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024 . Cost of revenues for the second quarter of 2025 was immaterial, compared to cost of revenues of $0.9 million for the second quarter of 2024. Cost of revenues in 2025 are not comparable to the same period in 2024, which included cost of sales from direct commercial sales by BioLineRx prior to the Ayrmid transaction in November 2024 . Research and development expenses for the second quarter of 2025 were $2.3 million , compared to $2.2 million for the second quarter of 2024. The increase resulted primarily from certain one-time costs associated with the PDAC study at Columbia University , offset by lower expenses related to motixafortide due to the out-licensing of U.S. rights to Ayrmid, as well as a decrease in payroll and share-based compensation, primarily due to a decrease in headcount. There were no sales and marketing expenses for the second quarter of 2025, compared to $6.4 million for the second quarter of 2024. The decrease resulted primarily from the shutdown of U.S. commercial operations in the fourth quarter of 2024 following the Ayrmid transaction. General and administrative expenses for the second quarter of 2025 were $0.2 million , compared to $1.6 million for the second quarter of 2024. The decrease resulted primarily from the reversal of a provision for doubtful accounts following receipt of an overdue milestone payment from Gloria, a decrease in payroll and share-based compensation, primarily due to a decrease in headcount, as well as small decreases in a number of general and administrative expenses. Net non-operating expenses for the second quarter of 2025 were $1.9 million , compared to net non-operating income of $7.8 million for the second quarter of 2024. Non-operating income (expenses) for both periods primarily relate to fair-value adjustments of warrant liabilities on the balance sheet, as a result of changes in the Company's share price Net financial income for the second quarter of 2025 was $0.2 million , compared to net financial expenses of $1.6 million for the second quarter of 2024. Net financial income (expenses) for both periods primarily relate to loan interest paid, partially offset by investment income earned on bank deposits and gains on foreign currency (primarily NIS) cash balances due to the strengthening of the NIS during the period. The significant decrease in financial expenses in the 2025 period results from a substantial paydown of the BlackRock loan balance in November 2024 , following the transaction with Ayrmid. Net loss for the second quarter of 2025 was $3.9 million , compared to net income of $0.5 million for the second quarter of 2024. As of June 30, 2025 , the Company had cash, cash equivalents, and short-term bank deposits of $28.2 million , sufficient to fund operations, as currently planned, into the first half of 2027. Conference Call and Webcast Information To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 16, 2025; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally. About BioLineRx BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases. The Company's first approved product, APHEXDA® (motixafortide), is indicated in the U.S. for stem cell mobilization for autologous transplantation in multiple myeloma, and is being commercialized by Ayrmid Ltd. (globally, except Asia ) and Gloria Biosciences (in Asia). BioLineRx has retained the rights to develop motixafortide in metastatic pancreatic cancer (PDAC), and has a Phase 2b PDAC trial currently ongoing under a collaboration with Columbia University . In addition, BioLineRx is in discussions to expand its pipeline in the areas of oncology and/or rare diseases, where the Company can utilize its end-to-end expertise in drug development, regulatory affairs and manufacturing to bring life-changing innovation from bench to bedside. Learn more about who we are, what we do, and how we do it at www.biolinerx.com, or on Twitter and LinkedIn.  Forward Looking Statement Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," and "would," and describe opinions about future events. These include statements regarding management's expectations, beliefs and intentions regarding, among other things, expectations regarding pipeline expansion, the expected cash runway, and BioLineRx's business strategy. These forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates, including the degree and pace of market uptake of APHEXDA for the mobilization of hematopoietic stem cells for autologous transplantation in multiple myeloma patients; the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials, and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials, whether the clinical trial results for APHEXDA will be predictive of real-world results; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; whether access to APHEXDA is achieved in a commercially viable manner and whether APHEXDA receives adequate reimbursement from third-party payors; BioLineRx's ability to establish, manage, and maintain corporate collaborations, as well as the ability of BioLineRx's collaborators to execute on their development and commercialization plans; BioLineRx's ability to integrate new therapeutic candidates and new personnel as well as new collaborations; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for and ability to access sufficient additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; BioLineRx's ability to maintain the listing of its ADSs on Nasdaq; and statements as to the impact of the political and security situation in Israel on BioLineRx's business, which may exacerbate the magnitude of the factors discussed above. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2025 . In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law. Contacts: United States Irina Koffler LifeSci Advisors , LLC IR@biolinerx.com Israel Moran Meir LifeSci Advisors , LLC moran@lifesciadvisors.com CONDENSED CONSOLIDATED INTERIM STATEMENTS OF FINANCIAL POSITION (UNAUDITED) December 31 , June 30 , 2024 2025 in USD thousands Assets CURRENT ASSETS Cash and cash equivalents 10,436 7,189 Short-term bank deposits 9,126 20,970 Trade receivables 2,476 78 Prepaid expenses 443 572 Other receivables 1,478 203 Inventory 3,145 2,850 Total current assets 27,104 31,862 NON-CURRENT ASSETS Property and equipment, net 386 197 Right-of-use assets, net 967 800 Intangible assets, net 10,449 10,408 Total non-current assets 11,802 11,405 Total assets 38,906 43,267 Liabilities and equity CURRENT LIABILITIES Current maturities of long-term loan 4,479 4,479 Accounts payable and accruals: Trade 5,583 3,465 Other 3,131 2,767 Current maturities of lease liabilities 522 408 Warrants 1,691 4,360 Total current liabilities 15,406 15,479 NON-CURRENT LIABILITIES Long-term loan, net of current maturities 8,958 6,718 Lease liabilities 1,081 998 Total non-current liabilities 10,039 7,716 COMMITMENTS AND CONTINGENT LIABILITIES Total liabilities 25,445 23,195 EQUITY Ordinary shares 38,097 71,819 Share premium 353,693 327,475 Warrants 5,367 3,686 Capital reserve 17,547 17,148 Other comprehensive loss (1,416) (1,416) Accumulated deficit (399,827) (398,640) Total equity 13,461 20,072 Total liabilities and equity 38,906 43,267 CONDENSED CONSOLIDATED INTERIM STATEMENTS OF COMPREHENSIVE INCOME (LOSS) (UNAUDITED) Three months ended June 30 , Six months ended June 30 , 2024 2025 2024 2025 in USD thousands In USD thousands REVENUES: License revenues 3,550 304 9,481 559 Product sales, net 1,843 - 2,767 - Total revenues 5,393 304 12,248 559 COST OF REVENUES (897) (72) (2,352) (106) GROSS PROFIT 4,496 232 9,896 453 RESEARCH AND DEVELOPMENT EXPENSES (2,225) (2,326) (4,719) (3,949) SALES AND MARKETING EXPENSES (6,415) - (12,757) - GENERAL AND ADMINISTRATIVE EXPENSES (1,629) (209) (3,015) (1,198) OPERATING LOSS (5,773) (2,303) (10,595) (4,694) NON-OPERATING INCOME (EXPENSES), NET 7,807 (1,851) 12,297 5,793 FINANCIAL INCOME 535 490 1,100 784 FINANCIAL EXPENSES (2,085) (276) (3,014) (696) NET INCOME (LOSS) AND COMPREHENSIVE INCOME (LOSS) 484 (3,940) (212) 1,187 in USD In USD EARNINGS )LOSS( PER ORDINARY SHARE - BASIC AND DILUTED 0.00 (0.00) (0.00) 0.00 WEIGHTED AVERAGE NUMBER OF SHARES USED INCALCULATION OF EARNINGS )LOSS( PER ORDINARY SHARE 1,197,582,901 2,369,687,536 1,142,221,033 2,294,127,662 CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN EQUITY (UNAUDITED) Ordinary shares Share premium Warrants Capital reserve Other comprehensive loss Accumulated deficit Total in USD thousands BALANCE AT JANUARY 1, 2024 CHANGES FOR SIX MONTHS ENDED JUNE 30, 2024: 31,355 355,482 1,408 17,000 (1,416) (390,606) 13,223 Issuance of share capital and warrants, net 3,056 (3,056) - - - - - Employee stock options expired - - - (66) - - (66) Share-based compensation - - - 1,036 - - 1,036 Comprehensive loss for the period - - - - - (212) (212) BALANCE AT JUNE 30, 2024 34,411 352,426 1,408 17,970 (1,416) (390,818) 13,891 Ordinary shares Share premium Warrants Capital reserve Other comprehensive loss Accumulated deficit Total in USD thousands BALANCE AT JANUARY 1, 2025 CHANGES FOR SIX MONTHS ENDED JUNE 30, 2025 : 38,097 353,693 5,367 17,547 (1,416) (399,827) 13,461 Issuance of share capital, pre-funded warrants and warrants, net 25,664 (20,988) 501 - - - 5,177 Pre-funded warrants exercised 8,058 (5,876) (2,182) - - - - Employee stock options expired - 646 - (646) - - - Share-based compensation - - - 247 - - 247 Comprehensive income for the period - - - - - 1,187 1,187 BALANCE AT JUNE 30, 2025 71,819 327,475 3,686 17,148 (1,416) (398,640) 20,072 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) Six months ended June 30 , 2024 2025 in USD thousands CASH FLOWS - OPERATING ACTIVITIES Comprehensive income (loss) for the period (212) 1,187 Adjustments required to reflect net cash used in operating activities (see appendix below) (25,226) (3,955) Net cash used in operating activities (25,438) (2,768) CASH FLOWS - INVESTING ACTIVITIES Investments in short-term deposits (20,559) (24,818) Maturities of short-term deposits 28,660 12,926 Sale (purchase) of property and equipment (59) 11 Net cash provided by (used in) investing activities 8,042 (11,881) CASH FLOWS - FINANCING ACTIVITIES Issuance of share capital and warrants, net of issuance costs 5,565 13,554 Net proceeds from loan 19,223 - Repayments of loan (1,547) (2,240) Repayments of lease liabilities (256) (262) Net cash provided by financing activities 22,985 11,052 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 5,589 (3,597) CASH AND CASH EQUIVALENTS – BEGINNING OF PERIOD 4,255 10,436 EXCHANGE DIFFERENCES ON CASH AND CASH EQUIVALENTS (221) 350 CASH AND CASH EQUIVALENTS - END OF PERIOD 9,623 7,189 BioLineRx Ltd. APPENDIX TO CONDENSED CONSOLIDATED INTERIM CASH FLOW STATEMENTS (UNAUDITED) Six months ended June 30 , 2024 2025 in USD thousands Adjustments required to reflect net cash used in operating activities: Income and expenses not involving cash flows: Depreciation and amortization 1,373 341 Exchange differences on cash and cash equivalents 221 (350) Fair value adjustments of warrants (12,845) (6,410) Warrant issuance costs 642 702 Share-based compensation 970 247 Interest on short-term deposits 201 48 Interest on loan 1,997 - Exchange differences on lease liabilities 189 110 (7,252) (5,312) Changes in operating asset and liability items: Decrease (increase) in trade receivables (2,821) 2,398 Decrease (increase) in prepaid expenses and other receivables (359) 1,146 Decrease (increase) in inventory (1,681) 295 Decrease in accounts payable and accruals (5,633) (2,482) Decrease in contract liabilities (7,480) - (17,974) 1,357 (25,226) (3,955) Supplemental information on interest received in cash 931 583 Supplemental information on interest paid in cash 971 694 Supplemental information on non-cash transactions: Changes in right-of-use asset and lease liabilities 58 45 Warrant issuance costs 207 - Logo - https://mma.prnewswire.com/media/2154863/BioLineRx_Ltd_Logo.jpg View original content:https://www.prnewswire.com/news-releases/biolinerx-reports-second-quarter-2025-financial-results-and-provides-corporate-update-302530015.html SOURCE BioLineRx Ltd. +972-8-6429100

SAN DIEGO, Aug. 13, 2025 /PRNewswire/ -- Inhibrx Biosciences, Inc. (Nasdaq: INBX) ("Inhibrx" or the "Company") today reported financial results for the second quarter of 2025. Following the completion of the sale of INBRX-101 (the "101 Transaction") by Inhibrx, Inc. (the "Former Parent") to Sanofi S.A. and the Former Parent's concurrent spin-off of the Inhibrx business in May 2024, the biopharmaceutical company now has two programs in ongoing clinical trials, with data readouts for each expected within the current year. Because the spin-off was accounted for as a reverse spin-off, for periods prior to the spin-off, the Company's financial statements are the historical financial statements of the Former Parent. Upcoming Milestones The ozekibart (INBRX-109) registration-enabling Phase 2 trial in unresectable or metastatic conventional chondrosarcoma completed full enrollment in July 2025. The completion of 151 progression free survival events are required to unblind the study. The Company expects to announce these results by late October 2025. The Company plans to announce interim data from the Ewing sarcoma and colorectal cancer expansion cohorts at that time as well. Initial Phase 2 data from the INBRX-106 randomized Phase 2/3 trial in head and neck squamous cell carcinoma in combination with KEYTRUDA® (pembrolizumab) are expected during the fourth quarter of 2025, as well as interim data from the Phase 1/2 checkpoint inhibitor refractory or relapsed non-small cell lung cancer trial. Financial Results Cash and Cash Equivalents. As of June 30, 2025, Inhibrx had cash and cash equivalents of $186.6 million, as compared to $216.5 million as of March 31, 2025. Revenue. Revenue was $1.3 million during the second quarter of 2025, as compared to $0.1 million during the second quarter of 2024. The revenue recognized in the first quarter of 2025 was due to the completion of Inhibrx's performance obligations under a license and assignment agreement with Scithera, Inc. The revenue recognized in the second quarter of 2024 was related to an option and license agreement with Regeneron Pharmaceuticals, Inc. and was recognized following the grant of a six-month extension of the option term for one of the selected programs. R&D Expense. Research and development expenses were $22.3 million for the second quarter of 2025, as compared to $67.6 million for the second quarter of 2024. The decrease was primarily related to expenses in 2024 that did not recur in 2025, such as clinical trial and contract manufacturing activities under the INBRX‑101 program that were eliminated following the 101 Transaction, as well as additional stock option expense incurred upon acceleration of all unvested stock options as part of the 101 Transaction. Additionally, 2024 included other non-recurring expenses including sponsored research, preclinical activities, and purchases of bulk raw materials and lab supplies. G&A Expense. General and administrative expenses were $6.4 million during the second quarter of 2025, compared to $93.4 million during the second quarter of 2024. The decrease was primarily related to 101 Transaction expenses in 2024 that did not recur in 2025, including legal, advisory, and consulting services, U.S. Securities and Exchange Commission ("SEC") filing fees, and additional stock option expense incurred upon acceleration of all unvested stock options as part of the 101 Transaction. Other Income (Expense). Other expense was $1.3 million during the second quarter of 2025, as compared to other income of $2.0 billion during the second quarter of 2024. The decrease was primarily related to the $2.0 billion gain recorded in connection with the completion of the 101 Transaction in the second quarter of 2024. Additionally, interest expense decreased relative to the outstanding debt balance in each period and was offset in part by interest income earned on the Company's sweep and money market account balances in each period. Net Income (Loss). Net loss was $28.7 million during the second quarter of 2025, or $1.85 per share, basic and diluted, as compared to a net income of $1.9 billion during the second quarter of 2024, or earnings per share of $127.10, basic and $125.48, diluted. The decrease was primarily related to the $2.0 billion gain recorded in connection with the completion of the 101 Transaction in the second quarter of 2024, offset in both periods by operational losses. About Inhibrx Biosciences, Inc. Inhibrx is a clinical-stage biopharmaceutical company with a pipeline of novel biologic therapeutic candidates. Inhibrx utilizes diverse methods of protein engineering to address the specific requirements of complex target and disease biology, including its proprietary protein engineering platforms. Inhibrx was incorporated in January 2024 as a direct, wholly-owned subsidiary of Inhibrx, Inc. Prior to the sale of Inhibrx, Inc. and the INBRX-101 program to Sanofi S.A., Inhibrx acquired certain corporate infrastructure and other assets and liabilities through a series of internal restructuring transactions effected by Inhibrx, Inc. Inhibrx, Inc. also completed a distribution to holders of its shares of common stock of 92% of the issued and outstanding shares of Inhibrx. Following such transactions, Inhibrx's current clinical pipeline of therapeutic candidates includes ozekibart (INBRX-109) and INBRX-106, both of which utilize multivalent formats where the precise valency can be optimized in a target-centric way to mediate what Inhibrx believes to be the most appropriate agonist function. For more information, please visit . Forward Looking Statements Inhibrx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Inhibrx's current beliefs and expectations. These forward-looking statements include, but are not limited to, statements regarding expected data readouts and the timing thereof and the Company's ability to develop therapeutic candidates. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Inhibrx's business, including, without limitation, risks and uncertainties regarding: the initiation, timing, progress and results of its preclinical studies and clinical trials, and its research and development programs; its ability to advance therapeutic candidates into, and successfully complete, clinical trials; the Company's ability to utilize the Company's technology platform to generate and advance additional therapeutic candidates; the implementation of the Company's business model and strategic plans for the Company's business and therapeutic candidates; the scope of protection the Company is able to establish and maintain for intellectual property rights covering the Company's therapeutic candidates; the ability to raise funds needed to satisfy the Company's capital requirements, which may depend on financial, economic and market conditions and other factors, over which the Company may have no or limited control; the Company's financial performance; developments relating to the Company's competitors and the Company's industry; regulatory review and approval of the Company's therapeutic candidates; and other risks described from time to time in the "Risk Factors" section of its filings with the SEC, including those described in its Annual Report on Form 10-K, its Quarterly Reports on Form 10-Q, and supplemented from time to time by its Current Reports on Form 8-K as filed from time to time. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Inhibrx undertakes no obligation to update these 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. Investor and Media Contact: Kelly D. Deck Chief Financial Officer [email protected] 858-795-4260 SOURCE Inhibrx Biosciences, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

「  本文共：10条资讯，阅读时长约：15分钟 」 药研资讯 1.安科生物CD7 CAR-T疗法拟纳入突破性治疗品种。安科生物参股公司博生吉医药开发的PA3-17注射液（靶向CD7的自体CAR-T疗法）被国家药监局纳入拟突破性治疗品种，用于治疗成人复发/难治性T淋巴母细胞白血病/淋巴瘤。早期临床数据显示客观缓解率高达85%，采用非基因编辑技术避免脱靶风险，为全球首个针对T细胞血液肿瘤的CAR-T疗法。 2. 恒瑞医药双药联合疗法获突破性治疗认定。恒瑞医药子公司研发的注射用瑞康曲妥珠单抗（HER2 ADC）联合阿得贝利单抗（PD-L1抑制剂）被纳入拟突破性治疗品种，用于PD-L1阳性三阴性乳腺癌一线治疗。两款药物累计研发投入超21亿元，此前已分别获批肺癌和小细胞肺癌适应症。 3. 中国创新药交易额全球占比首破50%。医药魔方数据显示，2025年中国创新药BD交易总额占全球52.5%，首次成为全球第一。License-out占比达44%，如恒瑞与GSK达成120亿美元合作。董事长周立运指出，中国从“跟随创新”转向“源头创新”，但需避免靶点扎堆导致的“内卷”。 4. 国家医保局公示534个药品通过国谈初审。国家医保局公告显示，534个药品通过2025年医保目录形式审查，其中目录外创新药310个，同比增加24.5%。今年首次增设“商保创新药目录”，121个药品通过初审，形成“医保+商保”双通道机制，减轻患者负担并缓解医保基金压力。 5. 拜耳13亿美元合作开发KRAS G12D抑制剂。拜耳与金橘生物科学公司达成全球独家协议，共同开发靶向KRAS G12D突变体的精准肿瘤药物。该突变存在于25%的癌症中，金橘将完成Ia期研究，拜耳负责后续开发及商业化，金橘最高可获得13亿美元款项。 6. AI药物研发最大合作落地：XtalPi获60亿美元订单。AI制药公司XtalPi与DoveTree达成总价值60亿美元的合作，聚焦“不可成药”靶点（如RAS、Myc）的药物开发，覆盖肿瘤、神经疾病等领域。XtalPi获得5100万美元首付款，后续可通过里程碑付款及特许权使用费获得总计58.9亿美元。 7. FDA批准7月五大创新疗法，覆盖多发性骨髓瘤与肺癌。7月FDA批准包括再生元制药双靶点抗体林沃塞他单抗（多发性骨髓瘤，缓解率70%）和迪扎尔制药EGFR抑制剂松沃替尼（肺癌，缓解率53.3%）。此外，首款遗传性血管水肿口服药塞贝拉司特、心衰药物非奈立酮及手部湿疹药德尔戈替尼均获批上市。 8. 2025上半年全球医药交易首付金额激增136%。2025年H1全球医药交易总额1304亿美元（同比+58%），首付款118亿美元（同比+136%）。中国贡献近50%交易金额，License-out达72笔，首付款总额首次超过一级市场融资额，成为Biotech资金回笼主要渠道。 9. 泰恩康白癜风创新药II期临床成功，将申请突破性疗法。泰恩康宣布1类新药CKBA软膏治疗非节段型白癜风的II期临床结果积极，高剂量组36%患者实现皮肤复色，安全性良好。公司计划立即申请突破性疗法认定并启动III期临床。 10. 科济药业实体瘤CAR-T提交上市申请，疗效突破晚期胃癌治疗。科济药业靶向Claudin18.2的CAR-T疗法“舒瑞基奥仑赛”已提交上市申请，II期数据显示其显著延长晚期胃/食管癌患者生存期，为末线患者提供突破性选择。中国企业在全球25个CD7 CAR-T研发项目中占比80%，引领实体瘤技术突破。 股市资讯 8月12日A股医药公司涨幅TOP 3 赛诺医疗（688108.SH） +14.00% 南微医学（688029.SH） +6.00% 复星医药（600196.SH） +5.60% 8月12日A股医药公司跌幅TOP 2 科华生物（002022.SZ） -3.44% 润都股份（002923.SZ） -1.22% 8月12日港股医药公司涨幅TOP 3 复星医药（02196.HK） +7.55% 晶泰控股（02228.HK） +3.22% 丽珠医药（01513.HK） +2.35% 评审动态 8月11日新药临床试验申请IND（8月12日无新增数据） 8月8日新药上市申请NDA（8月9日至8月12日无新增数据） END