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FDA 批准上市的药品及药物传输技术

说明：

以下只是部分作为例子的产品。所列均为美国 FAD 批准上市的药物及药物传输技术，一般都

还没有授权在中国生产。针对于中国市场来讲，这些药品或传输技术大体有如下几种状况：

一、已经作为合法进口产品在中国市场销售。已经进口的产品，如果是合法进口的正品（即

排除黑、灰色市场和纯粹的假药），表明美国原厂家很可能已经授权某中国公司在中国进口并

经销此产品。但是此类产品一般都还没有在中国被授权制造。

二、在中国已出现相同国产产品，并且是美国原厂家在中国代工生产，或者确实已经授权某

中国药厂在中国独立生产。我们一般尽可能不再列出此类产品，除非某药品或传输技术有被再

次授权或多方授权的可能。

三、在中国已出现相同成分或功能的产品，并且虽然美国公司并未代工或授权生产，但由于

该产品的成分或结构没有专利保护，并且其生产技术和工艺已被中国药厂基本成功复制。

四、在中国已出现声称是“相同”药品，但实际是假冒产品，即某些中国药厂在并没有掌握

（或者只掌握部分但不是全部）该药品的成分和结构的生产技术情况下炮制的产品。

机会：

由于对“知识产权侵权/滥用”和“反向竞争”的顾虑，美国药物公司对向中国公司出让和授

权药物技术基本持否定态度。但是即使在这个大前提下，“裂缝”或例外的机会仍然存在，尤

其是在专家内行眼里或手中。有些机会是历史性的，与个别美国药物公司和历史和现状有关。

我们在此列出的药品和传输技术，代表与美国原厂家交易的机会。这种机会有许多可能，从购

买整套技术到获取在中国制造权利的机会、再到代工生产或合作经销，等。个别情况下甚至有

全球或某些国家地区买断的可能。药品的技术出让、授权和交易种类范围很广。即使在授权生

产一类中，仍有许多层次的深刻划分，无法简单化，更不能一概而论。

所列每个药品都是一个潜在的黄金机会。即使是如上第三类和第四类情况，若得到原厂家正宗

技术或授权生产仍然是一个极好的市场机会，因为“唯一合法授权生产的美国药品”的身份是

一个强有力的宣传和推广工具，可以轻易夺取未授权的药品和假药品在过去已经打开的市场。

专长：

VIP Global Assets （VIP 国际资产）是药物技术和有关知识产权国际交易多方面的美国专

家。除了已经授权代理的药品机会，我们可以创造和构建新的机会，并且提供从尽职调查到正

式协商并最后成交的全套服务。请与我公司联系洽谈细节。联系地址和电话见封底。

药品及药物传输机会资料目录

药品:

Aloxi (Palonosetron)

Eligard (leuprolide acetate)

Erwinaze (asparaginase Erwinia chrysanthemi)

Ethyol (amifostine)

Regnite (gabapentin enacarbil)

INCIVEK (telaprevir)

Fanapt (Iloperidone)

Trianex (triamcinolone acetonide)

Divigel (estradiol)

VIBATIV (telavancin)

Makena (hydroxyprogesterone caproate)

Evamist (estradiol)

药物传输技术（包括专用成品）:

SUMAVEL DosePro (sumatriptan injection)

Aloxi (palonosetron) 帕洛诺司琼

种类药品, Injection

药品名 (学名)

美国市场药名(商标)

FDA批准状态

帕洛诺司琼 palonosetron

Aloxi

2003年批准，继续有效

医疗应用

简介

目前在华状态

癌症化疗，防止和控制急性化疗所引起的恶心、呕吐症状

帕洛诺司琼(PALONOSETRON)是第二代5-HT3受体阻滞剂,适用于中~

重度呕吐化疗所引起的恶心、呕吐,其与传统5-HT3受体阻滞剂相比,具

有疗效高、作用时间长、用量小。

无授权。

General Information Palonosetron is an injectable anti-vomiting and anti-nausea agent taken just chemotherapy treatments. Palonosetron belongs to a relatively new, but well-known, class of anti-emetics, the 5-HT3 receptor antagonists.

Palonosetron is indicated for the prevention of acute or delayed nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy.

The recommended dosage of Aloxi is 0.25 mg administered as a single dose approximately 30 minutes before the start of chemotherapy. In Europe, the Palonosetron trademark is licensed under the name Onicit. It will be marketed in Italy by Italfarmaco, a privately owned pharmaceutical company.

Mechanism of

Action

Palonosetron is a selective serotonin subtype 3 (5-HT3) receptor antagonist with a strong binding affinity. 5-HT3 receptors are located on the nerve terminals of the vagus in the periphery and centrally in the chemoreceptor trigger zone of the area postrema. Cancer chemotherapy is associated with nausea and vomiting when serotonin is released from the enterochromaffin cells of the small intestine activates 5-HT3 receptors located on vagal afferents and activates the vomiting reflex. Palonosetron may also block ion channels involved in ventricular polarization may prolong action potential duration. The effect of palonosetron on blood pressure, heart rate, and ECG parameters including QTc were comparable to ondansetron and dolasetron in clinical trials.

Eligard (leuprolide acetate)

种类药品, injectable suspension

药品名 (学名)


FDA批准状态

leuprolide acetate

Eligard


医疗应用

简介

目前在华状态

晚期前列腺癌症状缓解

ELIGARD is a prescription medication for the palliative treatment (management of symptoms) of advanced prostate cancer. ELIGARD is an LHRH (luteinizing hormone-releasing hormone) agonist. It is designed to reduce the amount of testosterone in the body by reducing the testicles' production of testosterone. It is not a cure for advanced prostate cancer.

无授权。

General Information ELIGARD is available in 4 different prescription doses, giving flexible dosing options for the management of advanced prostate cancer. The ELIGARD 45 mg shot is a 6-month hormone therapy for the treatment of advanced prostate cancer. ELIGARD 45 mg provides a full year of hormone therapy with 2 injections at 6 month intervals.

Mechanism of Action ELIGARD is an LHRH agonist. Male hormones, such as testosterone, stimulate the growth of prostate cancer cells. The goal of hormonal therapy for advanced prostate cancer is to lower the body's level of male hormones. Most of the body's testosterone is made by the testicles; ELIGARD lowers the ability of the testicles to produce testosterone.

As with other LHRH agonists, the first shot of ELIGARD will make testosterone levels rise during the first and 2nd weeks. Patients may experience worsening of symptoms or new symptoms during the first weeks of treatment, including bone pain, nerve damage, blood in the urine, pressure on the spine, or difficulty urinating. However, within 2 to 4 weeks, ELIGARD then causes testosterone levels to fall.

Erwinaze (asparaginase Erwinia chrysanthemi)


药品名 (学名)


FDA批准状态

asparaginase Erwinia chrysanthemi

Erwinaze


医疗应用

简介

目前在华状态

癌症化疗

Treatment for patients with acute lymphoblastic leukemia (ALL).

无授权。

General Information Erwinaze™ (asparaginase Erwinia chrysanthemi) purified and isolated from the bacterium Erwinia chrysanthemi is approved by the FDA.

The indication is a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity (allergy) to native or pegylated E. coli-derived asparaginase (pegaspargase). It belongs to the group of asparaginases, which help to halt the development of existing ALL cells and prevent new cancer cells from forming

Mechanism of

Action

Erwinaze (asparaginase Erwinia chrysanthemi) breaks down the amino acid asparagine so that it cannot be used to support the life of leukemia cells. Without supplies of asparagine in combination with chemotherapy – the ALL cells eventually die

Ethyol (amifostine)


药品名 (学名)


FDA批准状态

amifostine

Ethyol


医疗应用

简介

目前在华状态

癌症化疗

Ethyol has been approved to reduce the renal toxicity associated with repeated administration of chemotherapy in subjects with advanced ovarian cancer.

无授权。

General Information Ethyol (amifostine) is an organic thiophosphate cytoprotective agent known chemically as 2-[(3-aminopropyl)amino]ethanethiol dihydrogen phosphate (ester) and has the following structural formula:

H2N(CH2)3NH(CH2)2S-PO3H2

Amifostine is a white crystalline powder which is freely soluble in water. Its empirical formula is C5H15N2O3PS and it has a molecular weight of 214.22.

Ethyol is the trihydrate form of amifostine and is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-use 10 mL vial contains 500 mg of amifostine on the anhydrous basis.

Mechanism of Action Ethyol is a prodrug that is dephosphorylated by alkaline phosphatase in tissues to a pharmacologically active free thiol metabolite. This metabolite is believed to be responsible for the reduction of the cumulative renal toxicity of cisplatin and for the reduction of the toxic effects of radiation on normal oral tissues. The ability of Ethyol to differentially protect normal tissues is attributed to the higher capillary alkaline phosphatase activity, higher pH and better vascularity of normal tissues relative to tumor tissue, which results in a more rapid generation of the active thiol metabolite as well as a higher rate constant for uptake into cells. The higher concentration of the thiol metabolite in normal tissues is available to bind to, and thereby detoxify, reactive metabolites of cisplatin. This thiol metabolite can also scavenge reactive oxygen species generated by exposure to either cisplatin or radiation.

Horizant (gabapentin enacarbil)

种类药品, Release Tablets 药品名 (学名)


FDA批准状态

gabapentin enacarbil

Horizant

2011 年批准，继续有效

医疗应用

简介

疗后遗留神经痛，多动腿综合征

The efficacy of Horizant in the treatment of patients with moderate-to-severe primary Restless Legs Syndrome was clinically proven. It is the first medication in its class to be approved for the treatment of moderate-to-severe primary Restless Legs Syndrome. Horizant is also approved for the management of postherpetic neuralgia (PHN) in adults.

无授权。目前在华状态

General Information Horizant is dosed once-daily and delivers a new chemical entity that utilizes naturally-occurring, nutrient transporters in the gastrointestinal tract to achieve efficient absorption into the body.

The approved daily dose of Horizant, which provides dose-proportional and extended exposure of gabapentin, for the treatment of RLS is 600mg per day.

Mechanism of Action After absorbtion, Horizant is rapidly converted into gabapentin, a compound works by binding to certain calcium channels in nerve terminals.

INCIVEK (telaprevir)

种类药品, 片剂

药品名 (学名)


FDA批准状态

telaprevir

INCIVEK


医疗应用

简介

目前在华状态

治疗丙型肝炎 (HCV), must be used with peginterferon alfa and

ribavirin.

INCIVEK (telaprevir) is a prescription medicine used with the medicines peginterferon alfa and ribavirin to treat chronic (lasting a long time) hepatitis C genotype 1 infection in adults with stable liver problems, who have not been treated before or who have failed previous treatment.

无授权。

General Information INCIVEK is used to treat chronic (lasting a long time) hepatitis C genotype 1 infection. For adults with stable liver problems, who have not been treated before or who have failed previous treatment. It must be used with the medicines pegylated interferon alfa (peginterferon alfa) and ribavirin.

Mechanism of

Action

INCIVEK directly targets the hepatitis C virus as it makes copies of itself inside the body. Then the two other medicines, peginterferon alfa and ribavirin, are used to help the body clear the remaining virus.

Fanapt （Iloperidone）伊潘立酮

种类药品, 片剂

药品名 (学名)


FDA批准状态

Iloperidone

Fanapt


医疗应用

简介

Fanapt is used for the treatment of schizophrenia in adults.

Fanapt (iloperidone) is an antipsychotic medication. It works by changing the effects of chemicals in the brain. Fanapt is used to treat schizophrenia. Fanapt may also be used for purposes not listed in this medication guide.

目前在华状态无授权。

General Information Fanapt is not for use in psychotic conditions related to dementia.

Mechanism of Action Fanapt® is an atypical antipsychotic approved for the treatment of schizophrenia in adults. Fanapt® is a serotonin (5-HT2) receptor and dopamine receptor antagonist.

Trianex (triamcinolone acetonide)

种类药品, 药膏

药品名 (学名)


FDA批准状态

triamcinolone acetonide

Trianex


医疗应用用于湿疹、过敏性皮炎等过敏性皮肤病，手癣、体癣、足癣、股癣等真

菌感染所致的皮肤病，亦适应甲沟炎，念珠菌性口角炎，尿布疹，浅表

性脓皮病等。

简介 Trianex is the only 0.05% triamcinolone acetonide ointment with a proprietary hydrous emulsified base in convenient packaging.

目前在华状态无授权。中国有仿造的 triamcinolone acetonide, 但没有 Trianex 特

殊的水乳化成药技术。

General Information Triamcinolone is a topical steroid. It reduces the actions of chemicals in the body that cause inflammation, redness, and swelling.

Triamcinolone topical is used to treat the inflammation caused by a number of conditions such as allergic reactions, eczema, and psoriasis. The dental paste form of triamcinolone is used to treat mouth ulcers.

Triamcinolone topical may also be used for purposes not listed in this medication guide.

Mechanism of Action topical steroid.

Divigel (estradiol)

种类药品, 药膏

药品名 (学名)


FDA批准状态

estradiol

Divigel

2007 年批准，继续有效

医疗应用 To help relieve uncomfortable hot flashes, including night sweats associated with menopause.

简介雌二醇（Estradiol）是甾体类激素药物，为白色或乳白色结晶粉末，有

吸湿性，几乎不溶于水。雌二醇低剂量有助孕的作用，大剂量能抑制催

乳素释放.

目前在华状态无授权。中国有仿造的 generic estrogen, 但没有 Divigel 特殊的

Estradiol 配方和成药技术。

General Information Divigel is approved by the FDA to reduce the severity and frequency of moderate to severe hot flashes. Severe hot flashes include night sweats that result in sleep disruptions.

It contains estradiol, all-natural and all-green vegetal form of estrogen that is derived from plants and is identical to the natural hormone produced by woman's body before menopause.

It is available in the lowest FDA-approved dose of estradiol gel, lotion, or spray (0.25 mg estradiol).

It’s easy to apply: Divigel fits conveniently into daily routine Divigel, a bioidentical estrogen therapy.

Mechanism of Action Estrogen therapy.

VIBATIV (telavancin)


药品名 (学名) telavancin

美国市场药名(商标) VIBATIV

FDA批准状态 2009 年批准，继续有效

医疗应用 Treats complicated skin and skin structure infections (cSSSI).

简介 VIBATIV treats adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive microorganisms:

• Staphylococcus aureus (including methicillin-susceptible and -resistant isolates)

• Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), or

• Enterococcus faecalis (vancomycin-susceptible isolates only)

Combination therapy may be clinically indicated if the documented or presumed pathogens include Gram-negative organisms.


General Information Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to telavancin. VIBATIV may be initiated as empiric therapy before results of these tests are known. To reduce the development of drug-resistant bacteria and maintain the effectiveness of VIBATIV and other antibacterial drugs, VIBATIV should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy

Mechanism of Action Antibiotic against bacterial infections

Makena (hydroxyprogesterone caproate)


药品名 (学名) hydroxyprogesterone caproate

美国市场药名(商标) Makena


医疗应用 Reduces risk of preterm birth in at-risk pregnant women.

简介 Makena (hydroxyprogesterone caproate injection) is the first drug approved by the FDA that is indicated to specifically reduce preterm birth risk. It fulfills a critical and previously unmet medical need for healthcare providers and high risk moms.


General Information Makena is the first treatment that offers healthcare providers and eligible moms the assurance of knowing that they are prescribing a product that has been rigorously reviewed for safety and efficacy, manufactured in a facility that is compliant with FDA regulations, and is consistent from dose to dose.1

Ther-Rx recognizes the importance of addressing treatment barriers. Ther-Rx established the Makena Care Connection to help facilitate the process of prescribing and obtaining Makena for healthcare providers and patients. The Makena Care Connection is actively processing prescriptions for Makena, and is facilitating access to the patient assistance program for patients who need financial support.

Mechanism of Action hormone (progestin) balance.

Evamist (estradiol)

种类药品, transdermal spray

药品名 (学名) estradiol

美国市场药名(商标) Evamist


医疗应用 Treats vasomotor symptoms (hot flashes) associated with menopause.

简介 Evamist (estradiol transdermal spray) has been proven to reduce moderate to severe hot flashes caused by menopause. It has been shown to reduce both the severity and frequency of hot flashes—all in a low dose of estrogen.


General Information Evamist is applied once-daily to a small area of skin on inner forearm. Because Evamist is a transdermal (delivered through the skin) medication, the estrogen goes directly to the bloodstream and acts to reduce moderate to severe hot flashes in the body's system. Though there are other products that contain estradiol, only Evamist is a once-daily spray. It delivers low doses of estrogen directly through the skin (transdermally) to bloodstream.

Mechanism of Action Hormone therapy. During menopause, woman's body produces less estrogen, causing many of the symptoms associated with menopause. Evamist uses 17ß-estradiol, an estrogen chemically synthesized from a plant source. Evamist is the only estrogen therapy spray approved by the FDA.

Evamist (estradiol transdermal spray) has been proven to be effective—all in a low dose of estrogen. Doctors agree that hormone therapy should always be used at the lowest effective dose.

SUMAVEL DosePro (sumatriptan injection)

种类药物传输系统专用成品

药品名 (学名)


FDA批准状态

sumatriptan

SUMAVEL DosePro


医疗应用

简介

目前在华状态

治疗偏头痛，无针头注射系统

The only commercially available prefilled disposable needle-free drug delivery system for subcutaneous injection. Preferred by patients over needle and syringe.

无授权。

General Information DosePro is designed to be patient-preferred so that life-enhancing injectable therapies are more readily adopted into everyday life. For physicians, this can mean better outcomes. For the pharmaceutical industry, this can mean differentiation and sustainable competitive advantage. With DosePro, everyone wins.

SNAP the tip, FLIP the lever, and PRESS against the skin, and DosePro delivers a single dose of liquid formulation into the subcutaneous tissue in less than 1/10th of a second…faster than human reaction time.

Selective subcutaneous delivery – prevents inadvertent intramuscular dosing; Primary container glass silicone-free and tungsten-free; Viscous formulation delivery ~ 2000cP; With over 60 patents worldwide extending through 2026, DosePro can truly bring sustainable competitive advantage to drug products

Mechanism of Action Upon pressing the uncapped DosePro against the skin, the energy stored as compressed nitrogen gas in a small reservoir is released.

This energy propels a plunger forward through the drug cartridge, quickly moving the liquid dose toward the nozzle.

A biphasic pressure profile builds within the drug cartridge (see above).

In the first few milliseconds, an initial peak pressure emits a small jet of liquid formulation through the nozzle, piercing the skin.

This is immediately followed by a liquid stream at a lower delivery pressure, depositing the remaining dose into the subcutaneous tissue.

These steps constitute the entire dosing event…in less than 1/10th of a second.

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