Pazopanib Hydrochloride

河北牵头的京津冀联盟集采和河北省集采，备受关注，原因有两个： 一是规则简单粗暴，最低价或次低价中标，独家品种必须满足特定降幅； 二是产品亮眼，很多是临床用量特别大的独家品种。 因此，标书发布后，几人欢喜多家愁。喜的是少数光脚企业，只要能狠下心降价，就有机会抢市场； 愁的是现有市场主导者，面临巨大挑战，还有很多独家品种，也在纠结要不要降价中标，现在全国价格一盘棋，牵一发动全身，河北降，全国就得降。 我之前整理了个产品的市场竞争格局，今天补充京津冀集采产品市场销售规模数据，大家可以通过数据，判断每个品种竞争态势，筛选产品机会。 举几个例子： 雷尼替丁注射剂，销售额6千多万，厂家较多，头部3个企业占了主要市场，且价格较高，如果有企业愿意降价，就能很快抢到市场。 乙酰半胱氨酸吸入剂，赞邦和海南斯达两家霸占市场，现在已有多家企业过评，大家都是光脚的，有机会快速抢市场。 山莨菪碱注射剂，成都第一制药独占，这次是否会被低价赶跑。 地佐辛注射剂，扬子江占九成，另一家是否会赌一把。 具体品种情况，大家结合我的数据，认真研究。 京津冀集采品种竞争格局和市场规模情况品种名称剂型同组企业数 市场规模（千万 元）市场份额TOP2苯唑西林注射剂204石药中诺30%，苏州二叶26%雷尼替丁注射剂286安徽长江39%，现代哈森30%乙酰半胱氨酸吸入用溶液剂2920赞邦51%，海南斯达38%溴己新注射剂286石家庄四药66%，一品红34%纳布啡注射剂45宜昌人福60%，扬子江36%布托啡诺注射剂49恒瑞99%依西美坦口服常释剂型815辉瑞95%，齐鲁4%(消旋)山莨菪碱注射剂472.7成都第一98%乳果糖口服液体剂2711雅培65%，韩美20%玻璃酸钠注射剂64.3生化学54%，昊海26%复方利血平氨苯蝶啶口服常释剂型2大蒜素注射剂710辰欣100%尿素[13C]呼气试验药盒、验药盒、诊断试剂盒52.6华亘安邦70%，海德润30%万古霉素注射剂717VANCOCIN81%，浙江医药10%地佐辛注射剂218扬子江91%，南京优科9%吡拉西坦口服常释剂型4001.2江西亿友76%，吉林双药7%喷他佐辛注射剂36华润双鹤100%普萘洛尔注射剂32.3朗欧100%羧甲司坦口服液体剂118北京诚济97%米那普仑口服常释剂型42上海现代100%琥珀酸亚铁口服常释剂型53.5金陵药业87%，成都地奥10%表柔比星注射剂83.3辉瑞80%，瀚晖11%阿戈美拉汀口服常释剂型86豪森82%，施维雅18%劳拉西泮口服常释剂型52大西洋43%，湖南洞庭38%戊乙奎醚注射剂61.3锦州奥鸿88%，恩华11%磷霉素氨丁三醇口服散剂36山西仟源62%，沈阳第一24%双氯芬酸钠缓释控释剂型23非诺贝特口服常释剂型723雅培95%帕利哌酮缓释控释剂型62豪森53%，强生47%中/长链脂肪乳(C6-24)注射剂71.4费森尤斯卡比64%，20%尼卡地平注射剂143安斯泰来93%，成都苑东4%贝尼地平口服常释剂型47协和发酵57%，山东华素43%碘美普尔注射剂37博莱科100%灭菌注射用水(500ml)注射剂442华仁40%，石药银湖22%钆喷酸葡胺注射剂54拜耳45%，北陆42%福莫特罗吸入用溶液8维拉帕米注射剂111.4上海禾丰100%羟乙基淀粉130/0.4电解质注射剂21湖南科伦100%普拉洛芬滴眼剂153日本千寿90%，山东海山8%奈达铂注射剂42吉林金恒47%，奥赛康38%丁螺环酮口服常释剂型4尼可刹米注射剂292瑞阳93%地奈德软膏剂5呋塞米口服常释剂型43他克莫司软膏剂156丹麦利奥85%，四川明欣8%加兰他敏注射剂62.5湖北民康95%绒促性素注射剂172.5丽珠50%，默克44%布美他尼口服常释剂型26地氯雷他定口服液体剂26硝酸异山梨酯口服常释剂型56阿莫西林/克拉维酸钾口服液体剂13夫西地酸软膏剂62香港澳美75%，丹麦利奥24%复方头孢克洛(克洛己新)口服液体剂2胰岛素注射剂11复方氨基酸(15)双肽(2)注射剂34科伦100%奥沙利铂甘露醇注射剂37美大康70%，辰欣30%肠内营养剂(TPF-D)口服液体剂27费森尤斯82%，雅培18%伊托必利口服常释剂型151雅培86%，迪沙13%氨酚羟考酮口服常释剂型35马林克罗88%，华泰晨光12%去氧肾上腺素注射剂93上海禾丰97%螺内酯口服常释剂型36异烟肼注射剂211.4信合68%，西南16%贝达喹啉口服常释剂型33.4强生100%卢帕他定口服常释剂型10培唑帕尼口服常释剂型41.5诺华95%维生素D2注射剂3替加氟栓剂6地诺孕素口服常释剂型77Jennapham98%地喹氯铵含片4班布特罗口服液体剂21岳阳新华达65%，南京海鲸35%头孢克洛缓释控释剂型65苏州西克罗35%，天津中央23%布洛芬口服液体剂1.3强生85%，新华制药6%右美沙芬愈创甘油醚(复方氢溴酸右美沙芬)口服液体剂54.5湖北凤凰白云山89%，南京海鲸6%氨溴特罗口服液体剂191韩美100%拉莫三嗪口服常释剂型82.4葛兰素史克94%佐匹克隆口服常释剂型84齐鲁33%，华润顺峰30%替考拉宁注射剂74浙江医药51%，赛诺菲49%环磷酰胺注射剂51.2百特75%，恒瑞20%利多卡因凝胶剂3氟伐他汀缓释控释剂型33瀚晖62%，北京诺华38%赖氨匹林注射剂221.5通用45%，美好西林20%脂肪乳(C14-24)注射剂191费森尤斯84%，力邦15%苯溴马隆口服常释剂型62Heumann83%，东阳光8%乌拉地尔缓释控释剂型4氨磷汀注射剂41美罗100%七叶皂苷钠注射剂171.2绿叶54%，爱民40%辅酶A注射剂26 数据来源：摩熵医药样本医院市场药品销售数据 市场规模数据来自2023年京津冀地区样本医院销售总额，单位千万元； 未统计低于千万元的产品 相关阅读： 简单粗暴的河北集采，有3类机会 河北集采简单粗暴，最多两家中选，地佐辛、谷红等大品种在列 已经购买“摩熵药筛”小程序全库正式年度会员朋友，可以直接联系客服，获取原始数据。 先用”摩熵药筛“小程序，可以查询产品的竞争、价格、市场销售数据。

Phase 1/2 data showed a median overall survival ("mOS") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone INVINCIBLE-3 Study is recruiting and expected to enroll 333 patients with leiomyosarcoma, liposarcoma and undeferential pleomorphic sarcoma; authorizations for the INVINCIBLE-3 Study have been received in the U.S., Canada, Europe and Australia SHELTON, Conn., Nov. 18, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that Christian F. Meyer M.D., Ph.D., Assistant Professor of Oncology and lead medical oncologist for adult sarcoma patients at Johns Hopkins University's Sidney Kimmel Cancer Center, presented final safety and efficacy data from the Company's Phase 1/2 clinical trial of INT230-6 that was used as a monotherapy in patients with relapsed, refractory, and metastatic sarcomas, along with an overview of the Company's ongoing INVINCIBLE-3 Study design (NCT06263231). Dr. Meyer shared the information during an oral podium presentation in a late-breaking session at the 2024 Connective Tissue Oncology Society ("CTOS") on November 16, 2024, at 9 AM PST. The abstract's lead author was Albiruni Razak, MB BCh, BM BCh, Clinician Investigator, Princess Margaret Cancer Centre at the University Hospital Network in Toronto, Ontario, Canada. Both Drs. Razak and Meyer, enrolled patients in the Phase 1/2 clinical trial. This year's annual CTOS conference was held in San Diego from November 13 to 16, 2024 at the Grand Hyatt. "The data in the Phase 1/2 study has shown that INT230-6 causes cell death leading to tumor necrosis, improved cancer recognition by immune cells, and an ignition of a systemic anti-cancer immune response that results in T-cells entering the tumor microenvironment and has shown a favorable safety profile in soft tissue sarcomas," said Dr. Razak. "Systemically delivered chemotherapies have severe side effects, including cardiotoxicity, and most sarcoma subtypes have only a minimal response to immunotherapies. In addition, most sarcoma patients remain on current therapies for only a few months prior to progression, death or excessive toxicity. Demonstrating statistically significant improvement in median overall survival for the INT230-6 treatment arm compared to the standard of care arm in the INVINCIBLE-3 Study would be a major step forward in treating patients with these deadly soft tissue sarcomas." Phase 1/2 Study (Sarcoma Subset Data: 15 Patients): Demographics: Median (min, max) lines for prior drug therapies: 3 (1.00, 7.00) Mean (SD) age: 62.8 (8.1) years and ranged from 41.9 to 76.1 years ECOG performance status at screening was 0, 1 and 2 for 2 (13.3%), 12 (80.0%), and 1 (6.7%) subjects respectively The sarcoma diagnoses of the Phase 2 patients included liposarcoma, pleomorphic sarcoma, leiomyosarcoma, chondrosarcoma, osteosarcoma (chondroid syringoma), myofibroblastic, osteosarcoma, Kaposi sarcoma and chordoma Efficacy: The mOS in the mixed sarcoma population: 21.3 months for INT230-6 The mOS had not been reached with 21.4 months of median follow-up for patients who received a cumulative INT230-6 dose volume that was greater than 40% of their total tumor burden INT230-6 extended overall survival in refractory sarcoma subjects by nearly 15 months as monotherapy when compared to a synthetic control group based on the Royal Marsden Hospital scoring method Sarcoma population's overall disease control rate (DCR): 93.3% (95% CI: 68.1, 99.8) at 2 months Median duration of response (DOR): 4.0 months (95% CI: 1.7, NA) and 11.3 months (95% CI: 2.8, NA) for subjects who received a cumulative dose of ≥ 40% of the total incoming total tumor burden INT230-6 demonstrated an increase in T-cells within the tumors 27% of patients had uninjected tumors shrink (abscopal effects), though tumors less than 1 cm were uninjected, untracked and unreported by investigators, so the true abscopal percentage is unknown; further radiomics work is on-going Safety INT230-6 demonstrated a favorable safety profile and was well-tolerated 3 subjects (20%) had one or more drug regimen-related Grade ≥ 3 Treatment Emergent Adverse Events (TEAE); all were grade 3 (there were no grade 4 or 5 TEAEs) INVINCIBLE-3 Study Overview The INVINCIBLE-3 Study is designed to evaluate INT230-6 administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed standard of care ("SOC") chemotherapy. The study endpoints are overall survival and safety, along with an exploratory quality of life (QoL) assessment using the EORTC-30 survey. This is a global randomized Phase 3 study comparing the efficacy and safety of INT230-6 intratumoral (IT) injection with any of three standard of care therapies (pazopanib, trabectedin, or eribulin) in approximately 333 adult participants with locally recurrent, inoperable, or metastatic soft tissue sarcoma ("STS") patients who had disease progression prior to study enrollment following standard therapies, which must have included an anthracycline-based regimen unless contraindicated. Participants may also have received a maximum of one additional regimen. Randomization will occur after screening and eligibility confirmation. As this is a survival study, there is no crossover allowed between SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) criteria. Participants will be prospectively stratified into 1 of 3 histologically defined STS strata: leiomyosarcoma liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic) undifferentiated pleomorphic sarcoma The comparator agents used are all U.S., Europe, Canadian and Australian-approved agents for sarcomas: pazopanib tablets, trabectedin, and eribulin mesylate. Authorizations for the INVINCIBLE-3 Study have been obtained from the U.S. FDA, Health Canada, the European Medicines Agency, and Australia's Therapeutic Goods Administration. Sites will be opened in 8 countries and the study is presently recruiting participants in the U.S., Canada, and Europe. "The safety and efficacy data of our lead drug candidate, INT230-6, generated for sarcomas was quite encouraging. Many insights were gained from the over 200 patients treated before initiating the INVINCIBLE-3 study and applied to the ongoing study. Our approach uses sophisticated interventional radiology technologies to guide needles into tumors to inject our novel cytotoxic drug, which is highly absorbed by tumors, and showed a potential meaningful impact on lengthening metastatic sarcoma patient lives, reducing toxicities and improving quality of life compared to current treatments in our first clinical trial," said Lewis H. Bender, Intensity's President and Chief Executive Officer. "Our unique chemistry enables water-based products to diffuse throughout tumors and into cancer cells, causing immunologic cell death." About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] CORE IR (516) 222-2560 Media Contact: Jules Abraham CORE IR [email protected] SOURCE Intensity Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED