排名前五的靶点	数量

GABAA receptor(γ-氨基丁酸A受体)	3
κ opioid receptor(κ-阿片受体)	1
SCNA(电压门控钠通道α亚基家族)	1
ATP2C1 x GABRA1 x GLRA1 x GRIA1	1
NPRA(利钠肽受体1)	1

关联

项与 Maruishi Pharmaceutical Co., Ltd. 相关的药物

Difelikefalin acetate

醋酸地非法林

靶点

κ opioid receptor

作用机制

κ opioid receptor激动剂

在研机构

Vifor Fresenius Medical Care Renal Pharma France S.A.S. [+8]

原研机构

CARA Therapeutics, Inc.

在研适应症

慢性肾病相关瘙痒 [+4]

非在研适应症

急性疼痛 [+9]

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2021-08-23

Ethanol

乙醇

靶点-

作用机制-

在研机构

Eton Pharmaceuticals, Inc. [+5]

原研机构

Maruishi Pharmaceutical Co., Ltd.

在研适应症

梗阻性肥厚型心肌病 [+3]

非在研适应症

子宫内膜异位症

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2003-10-06

Sivelestat Sodium Hydrate

西维来司钠

靶点

ELA2

作用机制

ELA2抑制剂

在研机构

Ono Pharmaceutical Co., Ltd. [+3]

原研机构

Ono Pharmaceutical Co., Ltd.

在研适应症

急性肺损伤 [+1]

非在研适应症

成人呼吸窘迫综合征

最高研发阶段批准上市

首次获批国家/地区

日本

首次获批日期2002-04-11

项与 Maruishi Pharmaceutical Co., Ltd. 相关的临床试验

JPRN-JapicCTI-195042 / Completed临床3期

A Phase 3 Study to Determine the Efficacy, Safety, and Pharmacokinetics of MR13A11A in the Intensive Care Setting

开始日期2019-12-24

申办/合作机构

Maruishi Pharmaceutical Co., Ltd.

JPRN-jRCT2080224954 / Completed临床3期

A Phase 3 Study to Determine the Efficacy, Safety, and Pharmacokinetics of MR13A11A in the Intensive Care Setting

开始日期2019-12-24

申办/合作机构

Maruishi Pharmaceutical Co., Ltd.

NCT04040439 / CompletedN/A

Precedex(Registered) Intravenous Solution Special Investigation (in Pediatric Patients)

Secondary Data Collection:To confirm the safety and effectiveness profiles under the actual medical practice of Precedex in Japan.

开始日期2019-07-30

申办/合作机构

Pfizer Inc.

[+1]

100 项与 Maruishi Pharmaceutical Co., Ltd. 相关的临床结果

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0 项与 Maruishi Pharmaceutical Co., Ltd. 相关的专利（医药）

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项与 Maruishi Pharmaceutical Co., Ltd. 相关的文献（医药）

2022-09-01·Biochemical and biophysical research communications

SR 57227A, a serotonin type-3 receptor agonist, as a candidate analgesic agent targeting nociplastic pain

Article

作者: Mitani, Osamu ; Sumi, Takuya ; Okamoto, Takashi ; Kubo, Erika ; Nakamura, Yukiko ; Koyama, Yoshihisa ; Kondo, Makoto ; Masui, Kuniharu ; Shimada, Shoichi ; Usui, Noriyoshi

Pain is influenced by various factors, such as fear, anxiety, and memory. We previously reported that pain-like behaviors in mice can be induced by environmental cues in which a pain stimulus was previously presented, and that pain was reduced using fentanyl (an opioid). Although opioid analgesics are currently used to treat persistent pain, their inappropriate use causes a significant number of deaths in the United States. Thus, alternative medicines to opioids are needed. Here, we reported that SR 57227A, a serotonin type-3 receptor agonist, significantly reduced pain-like behaviors. The number of c-Fos positive cells increased by environmental cues in PFC was decreased by SR 57227A. Moreover, SR 57227A reduced pain-like behaviors of the formalin test, and restored reductions in paw withdrawal thresholds by acidic saline intramuscular injection and sciatic nerve ligation. Unlike opioids, SR 57227A induced no preference behaviors as measured by the conditioned place preference test. These data suggested that SR 57227A is an effective alternative pain reliever to opioids that targets chronic pain.

2022-01-01·Yonago acta medica4区 · 医学

The Efficacy and Safety of Dexmedetomidine for Procedural Sedation in Patients Receiving Local Anesthesia Outside the Intensive Care Unit: A Prospective, Double-Blind, Randomized Clinical Phase III Trial in Japan

4区 · 医学

Article

作者: Okayama, Akifumi ; Oya, Nobuyo ; Takeda, Junzo ; Ozaki, Makoto ; Morita, Kiyoshi ; Hiraoka, Takehiko ; Matsumoto, Kazuo ; Inagaki, Yoshimi

BACKGROUND:

Few studies (in other countries than the US) have reported on the efficacy and safety of dexmedetomidine for sedation of patients undergoing surgical or medical procedures under local anesthesia without intubation outside the intensive care unit. We performed a randomized, double-blind study in Japan.

METHODS:

Adult patients were randomly allocated to receive placebo, dexmedetomidine 0.5 μg/kg (DEX 0.5 group), or dexmedetomidine 1.0 μg/kg (DEX 1.0 group) over 10 min. Then, both dexmedetomidine groups received dexmedetomidine 0.2-0.7 μg/kg/h for maintaining an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score of ≤ 4; however, propofol was administered to rescue patients whose score exceeded this value. The primary endpoint was the percentage of patients who did not require rescue propofol to achieve and maintain an OAA/S score of ≤ 4.

RESULTS:

In total, 162 patients were included in the placebo (n = 53), DEX 0.5 (n = 53), and DEX 1.0 (n = 56) groups. Propofol was not required in significantly more patients in the dexmedetomidine 0.5 and 1.0 μg/kg groups (52.8% and 57.1%, respectively) compared with the placebo group (1.9%) (P < 0.001 for both). Common adverse events were protocol-defined hypotension, respiratory depression and bradycardia. The incidence of bradycardia was significantly higher in the DEX 0.5 (26.4%) and DEX 1.0 (30.4%) groups than in the placebo group (9.4%) (P = 0.041 and P = 0.008, respectively).

CONCLUSION:

We concluded that a loading dose of 0.5 or 1.0 μg/kg dexmedetomidine followed by infusion at a rate of 0.2-0.7 μg/kg/h provided effective and well-tolerated sedation in patients undergoing surgical or medical procedures under local anesthesia without intubation.Clinical trials.gov identifier: NCT01438931.

2022-01-01·Yonago acta medica4区 · 医学

The Efficacy and Safety of Dexmedetomidine for Sedation During Surgery Under Epidural or Spinal Anesthesia: A Randomized, Double-Blind, Placebo-Controlled Study

4区 · 医学

Article

作者: Sakamoto, Atsuhiro ; Oya, Nobuyo ; Morita, Kiyoshi ; Hiraoka, Takehiko ; Yamakage, Michiaki ; Inagaki, Yoshimi ; Okayama, Akifumi

BACKGROUND:

Only a few studies have been reported on the use of dexmedetomidine for sedating surgical patients requiring epidural or spinal anesthesia. We conducted a randomized, double-blind, placebo-controlled, parallel-group study at 12 hospitals in Japan.

METHODS:

Adult patients were randomly allocated to receive an intravenous administration of placebo or dexmedetomidine at 0.067, 0.25, 0.5 or 1.0 µg/kg over 10 min after epidural or spinal anesthesia. All dexmedetomidine groups received dexmedetomidine 0.2-0.7 µg/kg/h to maintain an Observer's Assessment of Alertness/Sedation Scale (OAA/S) score of ≤ 4; however, propofol was administered to rescue patients who exceeded this score. Surgery was then started 15 min after study drug infusion in patients with OAA/S score of ≤ 4. The primary endpoint was the percentage of patients not requiring rescue propofol to achieve and maintain an OAA/S score of ≤ 4.

RESULTS:

Of the 120 enrolled and randomized patients, 119 were treated the study: 22 received placebo and 97 received dexmedetomidine (23-25 patients per dose). Significantly more patients did not require propofol in the dexmedetomidine 0.5 and 1.0 µg/kg groups (68.0% and 80.0%, respectively) compared to the placebo group (22.7%) (P = 0.003 and P < 0.001, respectively). Common adverse events (AEs) were protocol-defined respiratory depression, bradycardia and hypotension. There was no significant difference in the incidence of AEs between the dexmedetomidine and the placebo groups.

CONCLUSION:

We concluded that loading doses of 0.5 and 1.0 µg/kg dexmedetomidine, followed by an infusion at a rate of 0.2-0.7 µg/kg/h, provide effective and well-tolerated sedation for surgical patients during epidural or spinal anesthesia.Clinical trials.gov identifier: NCT01438957.

项与 Maruishi Pharmaceutical Co., Ltd. 相关的新闻（医药）

2024-05-13

·GlobeNewswire-Health Care

Cara Therapeutics Reports First Quarter 2024 Financial Results

Topline efficacy and safety results from KOURAGE 1 Part A portion of notalgia paresthetica (NP) pivotal program now expected by the end of 2Q24STAMFORD, Conn., May 13, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the first quarter ended March 31, 2024. “Our notalgia paresthetica (NP) pivotal clinical program is progressing ahead of schedule and we now expect to report topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We believe the medical dermatology community’s interest in our clinical program underscores the significant unmet need for an effective and safe anti-pruritic treatment for the sizeable NP patient population. We look forward to rapidly advancing the ongoing Phase 2/3 program of our differentiated asset, oral difelikefalin, in this common but under-explored sensory neuropathy.” KOURAGE Update KOURAGE 1 Part A is the dose-finding portion of the Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with NP. The Company enrolled 214 patients and expects topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024. Part A is not powered for statistical significance. This readout will provide key information, specifically the dose and sample size to initiate the Phase 3 pivotal portion of the program – Part B of KOURAGE 1 and the second study KOURAGE 2. Final topline results from the first pivotal study are expected by the end of 2025 with the second pivotal study results in early 2026. In March 2024, the Company hosted a virtual event, Meet the NP Experts, featuring a panel of leading dermatologists and key opinion leaders to discuss the unmet need in NP and the potential of oral difelikefalin. A replay of the webcast is available under “Events & Presentations” in the Investors section of the Company’s website, www.CaraTherapeutics.com. 1Q24 KORSUVA Injection U.S. Update In the first quarter of 2024, KORSUVA® (difelikefalin) injection generated net sales of approximately $1.8 million and the Company recorded collaborative revenue of approximately $800,000, which represented the Company’s share of the profit from sales of KORSUVA injection. Wholesalers shipped 111,720 vials to dialysis centers during the first quarter of 2024. On March 31, 2024, the Transitional Drug Add-On Payment Adjustment (TDAPA) period for KORSUVA injection expired. After the TDAPA period, KORSUVA injection is reimbursed through the ESRD PPS bundle. First Quarter 2024 Financial Results Cash, cash equivalents and marketable securities at March 31, 2024 totaled $69.8 million compared to $100.8 million at December 31, 2023. The decrease in the balance primarily resulted from $30.5 million of cash used in operating activities. For the first quarter of 2024, net loss was $30.7 million, or $(0.56) per basic and diluted share, compared to net loss of $26.7 million, or ($0.49) per basic and diluted share, for the same period in 2023. Revenues: Total revenue was $2.1 million and $6.2 million for the three months ended March 31, 2024 and 2023, respectively. Revenue primarily consisted of: $0.8 million and $2.8 million of collaborative revenue related to our share of the profit from CSL Vifor’s sales of KORSUVA injection to third parties during the three months ended March 31, 2024 and 2023, respectively.$0.6 million and $3.2 million of commercial supply revenue related to sales of KORSUVA injection to CSL Vifor during the three months ended March 31, 2024 and 2023, respectively.$0.6 million of other revenue related to royalty payments earned in conjunction with ex U.S. sales of KORSUVA/Kapruvia under agreements with CSL Vifor and Maruishi Pharmaceuticals Co. Ltd., or Maruishi, during the three months ended March 31, 2024, which were sold under the Purchase and Sale agreement with HCRX Investments Holdco, L.P. and Healthcare Royalty Partners IV, L.P., or the HCR Agreement, and considered non-cash. There was no other revenue during the three months ended March 31, 2023. Cost of Goods Sold: Cost of goods sold was $0.6 million and $2.6 million for the three months ended March 31, 2024 and 2023, respectively, related to commercial supply revenue for KORSUVA injection sales to CSL Vifor. Research and Development (R&D) Expenses: R&D expenses were $22.0 million for the three months ended March 31, 2024 compared to $24.3 million in the same period of 2023. The lower R&D expenses in 2024 were primarily due to decreases in stock-based compensation expense, payroll and related costs, travel costs and other related conference costs as well as lower costs associated with the discontinuation of our atopic dermatitis and advanced chronic kidney disease programs, partially offset by increases related to the oral difelikefalin NP program. General and Administrative (G&A) Expenses: G&A expenses were essentially flat at $6.8 million for the three months ended March 31, 2024 compared to $6.9 million in the same period of 2023. Restructuring Expenses: Restructuring expenses were $2.4 million for the three months ended March 31, 2024 which were related to our strategic prioritization of NP and the associated workforce reduction in the 2024 period. There were no restructuring expenses recorded during the three months ended March 31, 2023. Other Income, net: Other income, net was approximately $1.0 million for each of the three months ended March 31, 2024 and 2023. Non-cash interest expense on liability related to sales of future royalties and milestones: Non-cash interest expense was $2.0 million which represented imputed interest on the carrying value of the liability associated with the HCR Agreement and the amortization of the related issuance costs associated with the HCR Agreement for the three months ended March 31, 2024. There was no non-cash interest expense for the three months ended March 31, 2023. Financial Guidance Cara expects that our current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund our currently anticipated operating plan into 2026. Our current operating plan assumes certain costs related to our planned pivotal trials in NP. About the KOURAGE Phase 2/3 Clinical Program in Notalgia Paresthetica KOURAGE is a Phase 2/3 clinical program evaluating oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica (NP). The program is comprised of two studies – KOURAGE 1 and KOURAGE 2 – which will likely be double-blind, placebo-controlled, 8-week studies with patients allowed to roll-over into open-label 52-week extensions. KOURAGE 1 is composed of two parts. The dose-finding portion of KOURAGE 1 (Part A) includes 214 patients who are randomized equally to four arms (0.25 mg BID, 1.0 mg BID, 2.0 mg BID, placebo BID). Part A is not powered for statistical significance. Part B and KOURAGE 2 will likely be double-blind, placebo-controlled, 8-week studies with patients randomized 1:1 to either difelikefalin or matching placebo. The primary endpoint for both the dose-finding portion of KOURAGE 1 (Part A) and the two pivotal studies Part B and KOURAGE 2 will likely be the proportion of patients with a ≥4-point improvement at Week 8 from baseline in the worst itch numeric rating scale. About Cara Therapeutics Cara Therapeutics is a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company is developing an oral formulation of difelikefalin, a selective, peripherally acting, non-scheduled kappa opioid receptor agonist, for the treatment of chronic pruritus associated with notalgia paresthetica (NP), a common, underdiagnosed neuropathy affecting the upper back for which there are no FDA-approved therapies. The Company is conducting a Phase 2/3 clinical program in NP with topline results of the dose-finding portion expected by the end of the second quarter of 2024. Cara Therapeutics also developed an IV formulation of difelikefalin, which is approved in the United States, EU, and multiple other countries for the treatment of moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis. The IV formulation is out-licensed worldwide. For more information, visit www.CaraTherapeutics.com and follow the company on X (Twitter), LinkedIn and Instagram. Forward-looking Statements Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the Company’s planned future regulatory submissions and potential future regulatory approvals, future product launches, expected timing of the initiation, enrollment and data readouts from the Company’s planned and ongoing clinical trials, the potential results of ongoing clinical trials, timing of future regulatory and development milestones for the Company’s product candidate, the potential for the Company’s product candidate to be an alternative in the therapeutic areas investigated, including notalgia paresthetica, the size and growth of the potential markets for pruritus management such as notalgia paresthetica, the commercial potential of the Company’s product candidate, and the Company’s cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. The risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ending December 31, 2023 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2024. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. CARA THERAPEUTICS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(in thousands)(unaudited) March 31, December 31, 2024 2023 Assets Current assets: Cash and cash equivalents$46,996 $ 51,775 Marketable securities 22,777 48,983 Accounts receivable, net - related party 1,718 2,765 Inventory, net 2,741 2,821 Income tax receivable 697 697 Other receivables 506 555 Prepaid expenses 5,790 8,154 Restricted cash - 408 Total current assets 81,225 116,158 Operating lease right-of-use assets 3,826 4,864 Property and equipment, net 3,548 3,322 Restricted cash, non-current 1,500 1,500 Total assets$90,099 $125,844 Liabilities and stockholders’ equity Current liabilities: Accounts payable and accrued expenses$14,875 $25,592 Operating lease liability, current 220 - Total current liabilities 15,095 25,592 Liability related to sales of future royalties and milestones, net 38,376 37,079 Operating lease liability, non-current 6,825 6,088 Total liabilities 60,296 68,759 Commitments and contingencies - - Stockholders' equity: Preferred stock - - Common stock 54 54 Additional paid-in capital 745,381 742,036 Accumulated deficit (715,441) (684,745)Accumulated other comprehensive loss (191) (260)Total stockholders’ equity 29,803 57,085 Total liabilities and stockholders’ equity$90,099 $125,844 CARA THERAPEUTICS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS(amounts in thousands, except share and per share data)(unaudited) Three Months Ended March 31, 2024 2023 Revenue: Collaborative revenue$788 $2,750 Commercial supply revenue 640 3,191 Royalty revenue - 125 Clinical compound revenue 84 99 Other revenue 623 - Total revenue 2,135 6,165 Operating expenses: Cost of goods sold 620 2,590 Research and development 21,964 24,334 General and administrative 6,816 6,891 Restructuring 2,401 - Total operating expenses 31,801 33,815 Operating loss (29,666) (27,650) Other income, net 952 985 Non-cash interest expense on liability related to sales of future royalties and milestones (1,982) - Net loss$(30,696) $(26,665) Net loss per share: Basic and Diluted$(0.56) $(0.49) Weighted average shares: Basic and Diluted 54,588,090 53,872,038 MEDIA CONTACT:Annie Spinetta6 Degrees973-768-2170aspinetta@6degreespr.com INVESTOR CONTACT:Iris Francesconi, Ph.D.Cara Therapeutics203-406-3700investor@caratherapeutics.com

财报上市批准临床3期

2024-05-09

·药渡

【药渡药闻报告-仿制药篇】-2024年16期/总第77期

国内仿制药研发批准动态01新注册分类品种首家批准上市情况根据药渡数据调研，本次统计周期（2024.04.27-05.03）新增2个新注册分类首家过评受理号，涉及1个注射液，1个混悬液。与上次统计周期相比，本次增加2个新注册分类首家过评品种。新注册分类品种首家过评情况02一致性评价品种首家批准上市情况根据药渡数据调研，本次统计周期（2024.04.27-05.03）无新增一致性评价首家过评受理号。与上次统计周期相比，本次减少3个一致性评价首家过评品种。03新注册分类品种批准上市情况根据药渡数据调研，本次统计周期（2024.04.27-05.03）新注册分类新增43个过评受理号，涉及39个品种，包含4个滴眼剂，1个干混悬液，1个混悬液，2个胶囊剂，2个口服溶液剂，9个片剂，3个吸入溶液剂，17个注射剂。与上次统计周期相比，本次新注册分类过评品种与上周持平。新注册分类品种过评情况（部分）喷他佐辛注射液喷他佐辛是由丸石制药开发的阿片受体激动剂，临床上用于各种慢性剧痛，如癌性疼痛、创伤性疼痛、手术后疼痛等，也可作为外科手术麻醉的辅助用药，用于手术前或麻醉前给药，属于第二类精神药品。喷他佐辛注射液最早于1970年3月24日获PMDA批准在日本上市，1998年华润双鹤药业的首仿药物经NMPA批准在国内上市销售。根据药渡数据-仿制药库调研，目前喷他佐辛注射液原研尚未进入国内，国内共有3家企业拥有喷他佐辛注射液的生产批文。其中，安徽恒星制药于去年11月24日视同过评，成功拿下该品种的“首家过评”称号；此次过评的福安药业庆余堂制药为该品种的第2家过评企业。药渡数据-中国注册库信息显示，喷他佐辛注射液注册格局为“1+4”，过评格局为“0+2”。“首仿”企业华润双鹤药业的一致性评价申请目前正在审评审批中。此外，另有4家企业递交了喷他佐辛注射液的新3类报产申请，除了首家过评的安徽恒星制药和此次视同过评的福安药业庆余堂制药，其他2家企业的报产申请尚在审评审批中。药渡数据-中国销量库统计数据显示，喷他佐辛注射液近年来销售情况喜人，2022年度销售额接近9.5亿元，2023年前三季度销售额高达6.85亿元，全部市场份额由华润双鹤药业独家享有。随着越来越多的企业通过一致性评价审评，在不久的将来，华润双鹤药业一家独大的局面将被终结。未来市场格局如何变幻，药渡将持续关注。04一致性评价品种批准上市情况根据药渡数据调研，本次统计周期（2024.04.27-05.03）一致性评价新增1个过评受理号，涉及1个品种，包括1个注射剂。与上次统计周期相比，本次减少15个一致性评价过评品种。一致性评价品种过评情况05仿制药品种批准临床情况国内仿制药研发申报动态01新注册分类品种申报上市情况根据药渡数据调研，本次统计周期（2024.04.27-05.03）新注册分类数据新增49个新报受理号，涉及41个品种，包括1个滴剂，5个滴眼剂， 1个胶囊剂， 2个颗粒剂，4个口服溶液剂，12个片剂， 2个散剂，1个糖浆剂， 1个吸入溶液剂，12个注射剂。与上次统计周期相比，本次新注册分类申报品种与上周持平。新注册分类品种申报受理情况（部分）02一致性评价品种申报上市情况根据药渡数据调研，本次统计周期（2024.04.27-05.03）一致性评价数据新增6个新报受理号，涉及4个品种，包括1个胶囊剂，3个注射剂。与上次统计周期相比，本次增加2个一致性评价申报品种。一致性评价申报受理情况03仿制药补充申请情况04仿制药申报上市专利声明信息汇总国内仿制药研发领域热点聚焦01国内仿制药研发领域政策法规相关动态本周无仿制药研发领域相关政策法规发布。02国内仿制药研发领域热点新闻金鸿药业：关于获得药品注册证书的公告2024 年4月30日，金鸿药业股份有限公司发布公告称，本公司于近日收到国家药品监督管理局核准签发的关于头孢丙烯干混悬剂两个规格的《药品注册证书》。现将相关情况公告如下：一、药品基本情况药品名称：头孢丙烯干混悬剂剂型：口服混悬剂规格：（1）1.875g （2）0.25g注册分类：化学药品 3 类药品批准文号：国药准字 H20243605国药准字 H20243606二、对公司的影响及风险提示公司高度重视药品研发，严格控制药品研发、生产及销售各环节的质量及安全。本次获得头孢丙烯干混悬剂的药品注册证书，将进一步丰富公司产品线，提高公司市场竞争力，对公司未来的经营业绩产生积极影响。咨询、合作请联系作者小D有话说为方便读者阅读及保存，我们将周报原文整理成了PDF版本，如需获取全文，可点击最上方蓝字，在“药渡仿制”公众号后台回复“0508仿制药周报”获取全文。

一致性评价上市批准

2024-01-08

·CPHI制药在线

2023年日本批准新药简述

关注并星标CPHI制药在线2023年，日本共批准21款新药，其中化药10款，生物药及细胞疗法11款。从药物类型来看，化药研发越来越多样化。10款化药中包括5款小分子、3款合成多肽、1款抗生素和1款小干扰RNA。本文主要从基本信息、国际注册、涉及本药的医药交易、核心专利等情况，简述2023年日本批准的化药，为行业提供一些思考。注：本文所列新药是日本医药品医疗器械综合机构（PMDA）首次批准的新活性物质；不包含化学仿制药、疫苗、血液制品、生物类似药、新适应症、新剂型、新给药途径和改变适用人群等情形。参考来源：PMDA、FDA、EMA、NMPA等各大评审局，图片自制 1.1 Cefiderocol Sulfate Tosylate 简介：Cefiderocol Sulfate Tosylate是由盐野义制药株式会社研发的一种头孢菌素类抗生素，是一种PBPs抑制剂，用于治疗细菌感染、呼吸机相关性肺炎、细菌性肺炎、医院获得性肺炎、革兰氏阴性细菌感染和泌尿系统感染。国际注册：2019-11-14美国、2020-04-23 欧盟、2023-11-30日本；中国III期。相关交易：截止目前，该药已有三起披露的合作。 2022年06月15日, 盐野义制药和Global Antibiotic Research and Development Partnership Foundation与CHAI就cefiderocol达成合作； 2022年06月16日, 盐野义制药和Nhs England就FETCROJA? (CEFIDEROCOL)达成合作； 2023年09月12日, Orchid Pharma Ltd获得Global Antibiotic Research and Development Partnership Foundation关于cefiderocol的许可。核心专利：原研化合物专利WO2010050468A1于2009-10-27申请，已进入各大主流国家。其中，中国：CN102203100B预计2029-10-27到期。美国：US9238657B2橙皮书显示2033-11-14到期，已延长。 Cefiderocol Sulfate Tosylate结构式，图片来源：说明书 1.2 Zilucoplan 简介：Zilucoplan是由Ra Pharmaceuticals Inc和比利时联合化工集团研发的一种合成多肽，是一种C5抑制剂，用于治疗重症肌无力。国际注册：2023-09-25日本、2023-10-17美国；中国暂无进展。相关交易：暂未检索到公开交易。核心专利：原研化合物/序列专利WO2015191951A3于2015-06-12申请，已进入各大主流国家。其中，中国：CN106456701B预计2035-06-12到期。美国：橙皮书显示US10106579B2于2035-06-12到期。 Zilucoplan结构式，图片来源：说明书 1.3 Tenapanor hydrochloride 简介：Tenapanor hydrochloride（盐酸替纳帕诺）是由Ardelyx Inc研发的一种First-in-Class小分子药物，是一种NHE3抑制剂，用于治疗慢性肾功能不全、高磷血症、便秘和肠易激综合征。国际注册：2019-09-12美国、2023-09-25日本；中国：原研2.4类申请上市，2023-07-12承办（复星医药和Ardelyx共同申报）。相关交易：2017年12月11日, 复星医药获得Ardelyx关于Tenapanor的许可。核心专利：原研化合物专利WO2010078449A3于2009-12-30申请，已进入各大主流国家。其中，中国：CN103819403B预计2029-12-30到期；美国：US8541448B2橙皮书显示2033-08-01到期，已延长。 Tenapanor hydrochloride结构式，图片来源：说明书 1.4 Difelikefalin 简介：Difelikefalin（地非法林）是由Ferring Pharmaceuticals及Cara Therapeutics研发的一种First-in-Class合成多肽，是一种KOR1激动剂，用于治疗瘙痒症。国际注册：2021-08-23美国、2022-04-25欧盟、2023-09-25日本；中国：III期。相关交易：截止目前，本药涉及六项交易。 2012年05月03日, Chong Kun Dang Pharmaceutical获得Cara Therapeutics关于Difelikefalin的许可； 2012年05月03日, Chong Kun Dang Pharmaceutical获得Cara Therapeutics关于Difelikefalin的许可； 2018年05月23日, 维福公司获得Cara Therapeutics关于Difelikefalin的许可； 2019年08月21日, Cara Therapeutics获得Enteris BioPharma关于Difelikefalin的许可； 2020年10月20日, Cara Therapeutics和维福就Difelikefalin达成合作； 2023年09月25日, 丸石制药获得Cara Therapeutics Inc关于KORSUVA IV Injection的许可(里程碑付款)。核心专利：原研化合物/序列专利WO2008057608A8于2007-11-12申请，已进入各大评审局。其中，中国：CN101627049B预计2027-11-13到期；美国：US7402564B1橙皮书显示2027-11-12到期。 Difelikefalin结构式，图片来源：说明书 1.5 Inclisiran sodium 简介：Inclisiran sodium（英克司兰钠）是由Alnylam Pharmaceuticals Inc研发的一种First-in-Classs iRNA，是一种PCSK9抑制剂，用于治疗高胆固醇血症、血脂障碍、颈动脉疾病、杂合子家族性高胆固醇血症和动脉粥样硬化。国际注册：2020-12-09 欧盟、2021-12-22美国、2023-08-22中国、2023-09-25 日本相关交易：本药涉及两起交易。 2013年02月04日, Alnylam Pharmaceuticals和The Medicines Company就ALN-PCS02和Inclisiran sodium达成合作； 2021年09月06日, Novartis和英国国家医疗服务体系就Inclisiran sodium达成合作。核心专利：原研化合物/序列专利WO2014089313A1于2013-12-05申请，已进入各大主流国家。其中，中国：CN104854242B预计2033-12-05到期。美国：美国橙皮书显示US10125369B2 于2034-08-18到期，已延长。 Inclisiran sodium结构式，图片来源：说明书 1.6 Lenacapavir sodium 简介：Lenacapavir sodium（来那帕韦）是由Gilead Inc研发的一种First-in-Class小分子药物，是一种Capsid抑制剂，用于治疗HIV感染。国际注册：2022-08-17欧盟、2022-12-22美国、2023-08-0日本；中国：原研5.1类申请上市，涉及两个剂型，片剂及注射液。来那帕韦片（2023-09-23承办）、来那帕韦注射液（2023-09-28承办）。相关交易：暂未检索到公开交易。核心专利：原研化合物专利WO2018035359A1于2017-08-17申请，已进入各大主流国家。其中，中国：CN109890808B，预计2037-08-17到期；美国：橙皮书显示US10071985B2于2037-08-17到期。 Lenacapavir sodium结构式，图片来源：说明书 1.7 Ritlecitinib 简介： Ritlecitinib（利特昔替尼）是由辉瑞研发的一种小分子药物，是一种JAK3抑制剂和TEC抑制剂，用于治疗斑秃。国际注册：2023-06-23美国、2023-06-26 日本、2023-09-15 欧盟、2023-10-18 中国。相关交易：暂未检索到公开交易。核心专利：原研化合物专利WO2015083028A1于2014-11-20申请，已进入各大主流国家。其中，中国：CN106061973B，预计2034-11-20到期；美国：橙皮书显示US9617258B2于2034-12-03到期，已延长。 Ritlecitinib结构式，图片来源：说明书 1.8 Futibatinib 简介：Futibatinib（福巴替尼）是由大鹏药品工业株式会社和大冢制药株式会社研发的一种小分子药物，是一种FGFR1-4拮抗剂，用于治疗胆管上皮癌和胆管癌。国际注册：2022-09-30美国、2023-06-26日本、2023-07-04欧盟。中国：暂无进展。相关交易：暂未检索到公开交易。核心专利：原研化合物专利WO2013108809A1于2013-01-17申请，已进入各大主流国家。其中，中国：CN103958512B预计2033-01-17到期；美国：橙皮书显示US10434103B2于2033-02-23到期，已延长。 Futibatinib结构式，图片来源：说明书 1.9 Pegcetacoplan 简介：Pegcetacoplan是由Apellis Pharmaceuticals Inc研发的一种合成多肽，是一种C3抑制剂，用于治疗阵发性血红蛋白尿症和地图状萎缩。国际注册：2021-05-14美国、2021-12-13欧盟、2023-03-27日本；中国：暂无进展。相关交易：2020年10月27日, Apellis和Swedish Orphan Biovitrum就Pegcetacoplan达成合作。核心专利：原研化合物/序列专利WO2014078731A3于2013-11-15申请，已进入各大主流国家。其中，中国：CN105051057B预计2033-11-15到期。美国：橙皮书显示US11292815B2，于2033-11-15到期。 Pegcetacoplan结构式，图片来源：说明书 1.10 Avatrombopag Maleate 简介：Avatrombopag Maleate（马来酸阿伐曲泊帕）是由安斯泰来制药集团研发的一种小分子药物，是一种TpoR激动剂，用于治疗血小板减少和肝脏疾病。国际注册: 2018-05-21美国、2019-06-20欧盟、2020-04-14 中国、 2023-03-27 日本。相关交易：2018年03月19日, 复星医药获得Dova Pharmaceuticals（安斯泰来合作公司）关于阿伐曲泊帕的许可。核心专利：原研化合物专利WO2003062233A1于2003-01-15申请，已进入各大主流国家。其中，中国：CN1319967C于2023-01-15已经到期。美国：橙皮书显示US7638536B2于2025-05-05到期，已延长。 Avatrombopag Maleate结构式，图片来源：说明书参考资源： 1、药物信息：各大药物说明书 2、注册信息：PMDA、FDA、EMA、NMPA等国际评审局 3、专利信息：美国橙皮书、中国专利局、欧专局等作者简介：药丸，中国药科大学硕士毕业，具有法律及药学教育背景，拥有法律资格证和专利代理师资格证，致力研究药学和专利，做一颗有价值的药丸。智药研习社1月直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com▼更多制药资讯，请关注CPHI制药在线▼点击阅读原文，进入智药研习社~

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