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跨国公司与中国可持续发展(之五)——诺华“复方蒿甲醚”国际推广项目

１９９６年３３Ｈ获得欧洲专利；１９月９７
项目意义和影响
１．ＷＨ推荐的抗疟疾ｏ首选药，治愈率高专家估计全球范围内每
年新增疟疾病例３至５亿亿
例，导致每年超过１０万人０死亡，中９％是非洲儿童。其０
成。这是一种高效、低耐药
性抗疟疾药物，治愈率达到９％，甚至在多种药物产生５复方蒿甲醚在尼日利亚上市。２００５年３月２８日，中国政府授予
他各国政府，瑞士抗疟药物基金会，其他非政府机构等等。
的治疗方法—— 考古发现证明中国人在
两千多年前就已经使用青蒿来治疗疟疾。在中国科学家的努力下，经过二十多年的研发，我国研制成功了复方蒿甲醚。诺华自１９年开始和中方在全球密９１切合作，共同开发注册，共享专利，合作生产。通过诺华的国际影响力，首次将中国自主创新的药品推向国际市场，是中国的自主创新与国际合作的典范。
维普资讯
诺华 “ 复方蒿甲醚’ ’国际推广项目
项目特点
１中国自主创新与国际合作的典范．
傲，是中国医药界全球范围内最具国际
声誉的药品，在全球４９个国家拥有发
明专利保护和７９个国家获得药品注册，是我国拥有发明专利保护、获得注册国家最多的药品。２国际化 —— 复方蒿甲醚成功的．

一、诺华单人份核酸检测试剂参数

一、诺华单人份核酸检测试剂参数1.适用于核酸检测设备，试剂原理：转录介导扩增技术。

★2.试剂灵敏度：常规工作模式下： HIV-1：21.2 IU/ml、HCV: 5.4 IU/ml、HBV: 3.4 IU/ml★3.检测形式：检测系统能够在同一反应管内同时进行HBV DNA/HCV RNA/HIV-1 RNA三项核酸检测4.内置的过程控制：核酸检测试剂盒包含有内对照，能够监控核酸提取、扩增和检测全过程5.灵活的试管兼容性：检测试剂适合用于标本类型为血清以及EDTA、ACD、CPD、CPDA抗凝的血浆★6.全封闭系统：核酸提取、扩增、检测在同一密闭系统中进行，核酸纯化产物的转移无需人工干预7.扩增系统：扩增反应体系由仪器自动加样，检测试剂有防污染设计，降低污染发生★8.应急标本检测：检测系统能满足随时插入应急标本进行检测的需求。

9．检测模式：适用于单检或混样检测，对血站现有采供血流程应无影响。

★10.应急模式：单采血小板和应急标本必须实施单检模式，单采血小板和应急标本的判定由血液中心自行指定。

11.其他检测性能：针对HIV-1，具有两个或两个以上的检测区域。

二、BECKMAN COULTER丙氨酸氨基转移酶测定试剂盒（乳酸脱氢氨法）参数一、适用Beckman Coulter AU400分析仪二、试剂用途：定量测定人血清中的丙氨酸氨基转移酶（ALT）三、技术参数1．试剂准备：本试剂为即用型试剂，可以直接放在仪器上。

2．储藏和稳定性：在2-8℃不开封储藏时，试剂可保持稳定到声明的失效期；开封后，在分析仪上储藏时，可保持稳定30天3.参与反应成分的最终浓度：Tris 缓冲液，pH：7.15 (37°C) 100 mmol/LL- 丙氨酸 500 mmol/L2-氧戊二酸盐 12 mmol/LLDH ≥ 1.8 kU/LNADH 0.20 mmol/L4、线性：在3-500U/L(0.05-8.33ukat/L)的浓度范围内，实验结果呈线性。

扶他林是诺华集团最宝贵的资源

扶他林是诺华集团最宝贵的资源
药品是我们生活中所离不开的，要是说道治疗疼痛与炎症的药物，恐怕扶他林的品牌会响于很多人们的脑海里。

在中国，扶他林有口服片剂和外用乳胶膏两种剂型投入使用，至今已有12年历史，累计5000万人使用。

作为外用的非处方药物扶他林乳胶剂，在耐受性和安全性方面都明显优于其他品牌。

而且在改善股骨头坏死患者的疼痛症状有迅速的与持续的良好效果，逐渐被病人所接受与追捧!
为什么说扶他林作为治疗炎症以及疼痛方面十分著名呢?看一下扶他林的治疗症状我们就可见一斑：炎性和退行性风湿病：类风湿性关节炎、青少年型类风湿性关节炎、强直性脊椎炎、骨关节病和脊椎关节炎、脊椎痛性综合症都是扶他林的对症治疗病症。

非关节性的各种软组织风湿性疼痛，如肩痛、腱鞘炎、滑囊炎、肌痛及运动后损伤性疼痛等也可以使用扶他林治疗。

急性的轻、中度疼痛如：手术后、创伤后、劳损后、牙痛、头痛等;妇科中出现的疼痛或炎症，例如：原发性痛经或附件炎使用扶他林进行缓解或者是医治也是可以的。

同时扶他林对耳、鼻、喉的严重痛性感染可作为辅助治疗药，例如：咽扁桃体炎，耳炎。

原发疾病可根据一般治疗原则给予适当的治疗。

若说对于感冒之类的发热病症扶他林片剂可以使用吗?答案是肯定的，但是对于什么症状下应该服用多少扶他林以及和什么药物搭配使用的问题，还是要遵循医生的建议，祝大家身体健康。

诺华--Freedom to Operate (FTO) from a large company's perspective

ion
2. External projects
FTO analysis
• Conduct FTO searches to identify potentially relevant party rights relating to: - agent /compound - formulation/combination - process of manufacture (process steps and key intermediates) - Use • Validity/patentability assessment • If any issues arise: - Commercial impact? - Is the third party patent right valid/enforceable? - Is taking a license an option and consequences?
i.e. “clear the way”
Can the IP risks be mitigated?
• Are any applications pending and can they be used to improve IP position? - consider filing 3rd party observations • • Is there a potential for future “commercially relevant” patent filings? Can any granted IP be improved? - post-grant amendments (e.g. India) - the new European limitation procedure • • • Orange Book: de-listings, re-listings Can any 3rd party patents be opposed / challenged / licensed or acquired? Using an eventual deal structure: - minimal up-front payments and a greater emphasis on royalties; - option deal ... ... .

诺华在美受挫——关注泽马可遭FDA“停售令”

家有售，仅美国就有约５００患者。０００
对于那些正在使用泽马可的患者，ＦＤＡ建议他们联系医生商讨更换治疗
而言，他们从泽马可获得的疗效已经低于他们所可能承担的风险。诺华公司的研究包括了接受泽马可
了对２个短期（￣Ｊ个月）的泽马可随９１ｌ３
机对照临床试验的分析报告。根据这些分析结果，ＦＡ断定，对于大多数患者Ｄ
２０年８被批准用于治疗６岁以下患０４月５者的慢性便秘。泽马可在全球５个国５
眩晕，突然发生四肢无力或行走、说话困难、其他的心脏病发作或中风的话，应该立即到急诊室就诊。诺华公司在其网站上做了两点表
治疗的７０多名患者。相关数据显示，００服用泽马可的患者发生严重心血管不良事件（如心绞痛、心脏病发作以及中例风）的风险要高于使用安慰剂治疗的患
ｒ
壤 ‰ 懿＃鬻，
一
ＦＡＤ的要求，停止了在美国
豳
一销售洋马口。同时，话Ｊ
ＮＶｇＴＯＡｌ
年７月被批准的用于短程治疗女性肠易激综合征（ｒｉａｌｉｒｔｂｅ
ｂｗｅｙｄｏｏｌｎｒｍｅＩ）的药物，在ｓ，ＢＳ浮出水面。当时，诺华公司向ＦＤＡ呈送

诺华_依维莫司片英文说明书_2015.05.11

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use ZORTRESS® (everolimus) safely and effectively. See full prescribing information for ZORTRESS.ZORTRESS (everolimus) tablets for oral useInitial U.S. Approval: 2010WARNING: MALIGNANCIES AND SERIOUS INFECTIONS,KIDNEY GRAFT THROMBOSIS; NEPHROTOXICITY; AND MORTALITY IN HEART TRANSPLANTATIONSee Full Prescribing Information for Complete Boxed Warning.• Only physicians experienced in immunosuppressive therapy and management of transplant patients should use Zortress. (5.1)• Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression. (5.2, 5.3)• Increased incidence of kidney graft thrombosis. (5.4)• Reduced doses of cyclosporine are required for use in combination with Zortress in order to reduce nephrotoxicity. (2.4, 2.5, 5.6, 12.7,12.8)• Increased mortality in a heart transplant clinical trial. Use in heart transplantation is not recommended. (5.7)---------------------------RECENT MAJOR CHANGES--------------------------Dosage and Administration (2) 1/2015 Warnings and Precautions, Management ofImmunosuppression (5.1) 1/2015 Warnings and Precautions, Interstitial Lung Disease/Non-Infectious Pneumonitis (5.10) 11/2015---------------------------INDICATIONS AND USAGE---------------------------• Zortress is indicated for the prophylaxis of organ rejection in adult patients: • Kidney transplant: at low-moderate immunologic risk. Use in combination with basiliximab, cyclosporine (reduced doses) and corticosteroids. (1.1) • Liver transplant: Administer no earlier than 30 days post-transplant. Use in combination with tacrolimus (reduced doses) and corticosteroids. (1.2, 5.5) Limitations of Use (1.3)Safety and efficacy has not been established in the following:• Kidney transplant patients at high immunologic risk.• Recipients of transplanted organs other than kidney or liver• Pediatric patients (<18 years)-------------------------DOSAGE AND ADMINISTRATION--------------------• Kidney transplantation: starting oral dose of 0.75 mg twice daily as soon as possible after transplantation. (2.1)• Liver transplantation: starting oral dose of 1.0 mg twice daily starting 30 days after transplantation. (2.2)• Monitor everolimus concentrations: Adjust maintenance dose to achieve trough concentrations within the 3-8 ng/mL target range (using LC/MS/MS assay method (2.1, 2.2, 2.3)• Administer consistently with or without food at the same time as cyclosporine or tacrolimus. (2.6, 12.3)• Mild hepatic impairment: Reduce initial daily dose by one-third (2.7) • Moderate or Severe hepatic impairment: Reduce initial daily dose by one-half. (2.7, 12.6)-------------------------DOSAGE FORMS AND STRENGTHS------------------Zortress is available as 0.25 mg, 0.5 mg, and 0.75 mg tablets. (3)----------------------------------CONTRAINDICATIONS--------------------------• Hypersensitivity to everolimus, sirolimus, or to components of the drug product. (4)----------------------------WARNINGS AND PRECAUTIONS------------------• Angioedema (increased risk with concomitant ACE inhibitors): Monitor for symptoms and treat promptly. (5.8)• Delayed Wound Healing/Fluid Accumulation: Monitor symptoms; treat promptly to minimize complications. (5.9)• Interstitial Lung Disease/Non-Infectious Pneumonitis: Monitor for symptoms or radiologic changes; manage by dose reduction or discontinuation until symptoms resolve; consider use of corticosteroids. (5.10)• Hyperlipidemia (elevations of serum cholesterol and triglycerides): Monitor and consider anti-lipid therapy. (5.11)• Proteinuria (increased risk with higher trough concentrations): Monitor urine protein. (5.12)• Polyoma Virus Infections (activation of latent viral infections; BK-virus associated nephropathy): Consider reducing immunosuppression. (5.13)• TMA/TTP/HUS (concomitant use with cyclosporine may increase risk): Monitor for hematological changes or symptoms. (5.15)• New Onset Diabetes After Transplantation: Monitor serum glucose. (5.16) • Male Infertility: Azospermia or oligospermia may occur. (5.17, 13.1)• Immunizations: Avoid live vaccines. (5.18)----------------------------------ADVERSE REACTIONS--------------------------Most common adverse reactions were as follows:Kidney transplantation (incidence ≥20%): peripheral edema, constipation, hypertension, nausea, anemia, UTI, and hyperlipidemia. (6.1);Liver transplantation (incidence>10%): diarrhea, headache, peripheral edema, hypertension, nausea, pyrexia, abdominal pain, and leukopenia (6.1)To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA1088 or /medwatch.-----------------------------------DRUG INTERACTIONS-------------------------Strong-moderate CYP3A4 inhibitors (e.g., cyclosporine, ketoconazole, erythromycin, verapamil) and CYP3A4 inducers (e.g., rifampin) may affect everolimus concentrations. (7.1) Consider Zortress dose adjustment (5.14)---------------------------USE IN SPECIFIC POPULATIONS-------------------• Pregnancy: Based on animal data may cause fetal harm. (8.1)• Nursing Mothers: Discontinue drug or nursing. (8.3)See 17 for PATIENT COUNSELING INFORMATION and Medication GuideRevised: 11/2015FULL PRESCRIBING INFORMATION: CONTENTS* WARNING: MALIGNANCIES AND SERIOUS INFECTIONS, KIDNEY GRAFT THROMBOSIS; NEPHROTOXICITY; AND MORTALITY IN HEART TRANSPLANTATION1 INDICATIONS AND USAGE1.1 Prophylaxis of Organ Rejection in Kidney Transplantation1.2 Prophylaxis of Organ Rejection in Liver Transplantation1.3 Limitations of Use2 DOSAGE AND ADMINISTRATION2.1 Dosage in Adult Kidney Transplant Patients2.2 Dosage in Adult Liver Transplant Patients2.3 Therapeutic Drug Monitoring -Everolimus2.4 Therapeutic Drug Monitoring-Cyclosporine in KidneyTransplant Patients2.5 Therapeutic Drug Monitoring-Tacrolimus in Liver TransplantPatients2.6 Administration2.7 Hepatic Impairment3 DOSAGE FORMS AND STRENGTHS4 CONTRAINDICATIONS4.1 Hypersensitivity Reactions5 WARNINGS AND PRECAUTIONS5.1 Management of Immunosuppression5.2 Lymphomas and Other Malignancies5.3 Serious Infections5.4 Kidney Graft Thrombosis5.5 Hepatic Artery Thrombosis5.6 Zortress and Calcineurin Inhibitor-Induced Nephrotoxicity5.7 Heart Transplantation5.8 Angioedema5.9 Wound Healing and Fluid Accumulation5.10 Interstitial Lung Disease/Non-Infectious Pneumonitis5.11 Hyperlipidemia5.12 Proteinuria5.13 Polyoma Virus Infections5.14 Interaction with Strong Inhibitors and Inducers of CYP3A45.15 Thrombotic Microangiopathy/Thrombotic ThrombocytopenicPurpura/Hemolytic Uremic Syndrome (TMA/TTP/HUS)5.16 New Onset Diabetes After Transplant5.17 Male Infertility5.18 Immunizations5.19 Interaction with Grapefruit Juice5.20 Patients with Hereditary Disorders/Other6 ADVERSE REACTIONS6.1 Serious and Otherwise Important Adverse Reactions6.2 Clinical Studies Experience6.3 Postmarketing Experience7 DRUG INTERACTIONS7.1 Interactions with Strong Inhibitors or Inducers of CYP3A4 and Pglycoprotein7.2 Cyclosporine (CYP3A4/P-gp Inhibitor and CYP3A4 Substrate)7.3 Ketoconazole and Other Strong CYP3A4 Inhibitors7.4 Erythromycin (Moderate CYP3A4 Inhibitor)7.5 Verapamil (CYP3A4 and P-gp Substrate)7.6 Atorvastatin (CYP3A4 substrate) and Pravastatin (P-gp substrate)7.7 Simvastatin and Lovastatin7.8 Rifampin (Strong CYP3A4/P-gp Inducers)7.9 Midazolam (CYP3A4/5 substrate)7.10 Other Possible Interactions7.11 Octreotide7.12 Tacrolimus8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy8.3 Nursing Mothers8.4 Pediatric Use8.5 Geriatric Use8.6 Hepatic Impairment8.7 Renal Impairment10 OVERDOSAGE11 DESCRIPTION12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action12.3 Pharmacokinetics12.5 Drug-Drug Interactions12.6 Specific Populations12.7 Everolimus Whole Blood Concentrations Observed in Kidneyand in Liver Transplant Patients12.8 Cyclosporine Concentrations Observed in Kidney TransplantPatients12.9 Tacrolimus Concentrations in Liver Transplant13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility14 CLINICAL STUDIES14.1 Prevention of Organ Rejection after Renal Transplantation14.2 Prevention of Organ Rejection after Liver Transplantation16 HOW SUPPLIED/STORAGE AND HANDLING17 PATIENT COUNSELING INFORMATION* Sections or subsections omitted from the full prescribing information are not listedFULL PRESCRIBING INFORMATIONWARNING: MALIGNANCIES AND SERIOUS INFECTIONS, KIDNEY GRAFT THROMBOSIS;NEPHROTOXICITY; AND MORTALITY IN HEART TRANSPLANTATIONMalignancies and Serious Infections• Only physicians experienced in immunosuppressive therapy and management of transplant patients should prescribe Zortress. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have completeinformation requisite for the follow-up of the patient. [See Warnings and Precautions (5.1)]• Increased susceptibility to infection and the possible development of malignancies such as lymphoma and skin cancer may result from immunosuppression. [See Warnings and Precautions (5.2 and 5.3)]Kidney Graft Thrombosis• An increased risk of kidney arterial and venous thrombosis, resulting in graft loss, was reported, mostly within the first 30 days post-transplantation. [See Warnings and Precautions (5.4)]Nephrotoxicity• Increased nephrotoxicity can occur with use of standard doses of cyclosporine in combination with Zortress.Therefore reduced doses of cyclosporine should be used in combination with Zortress in order to reduce renaldysfunction. It is important to monitor the cyclosporine and everolimus whole blood trough concentrations. [See Dosage and Administration (2.4 and 2.5) and Warnings and Precautions (5.6) and Clinical Pharmacology (12.7 and12.8)]Mortality in Heart Transplantation• Increased mortality, often associated with serious infections, within the first three months post-transplantation was observed in a clinical trial of de novo heart transplant patients receiving immunosuppressive regimens with or without induction therapy. Use in heart transplantation is not recommended. [See Warnings and Precautions (5.7)]1 INDICATIONS AND USAGE1.1 Prophylaxis of Organ Rejection in Kidney TransplantationZortress is indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant. [See Clinical Studies (14.1)] Zortress is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. Therapeutic drug monitoring of everolimus and cyclosporine is recommended for all patients receiving these products. [See Dosage and Administration (2.2 and 2.3)] 1.2 Prophylaxis of Organ Rejection in Liver TransplantationZortress is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. Zortress is to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [See Warnings and Precautions (5.5) and Clinical Studies (14.2)]. Therapeutic drug monitoring of everolimus and tacrolimus is recommended for all patients receiving these products. [See Dosage and Administration (2.3 and 2.5)]1.3 Limitations of UseThe safety and efficacy of Zortress has not been established in the following populations:Kidney transplant patients at high immunologic riskRecipients of transplanted organs other than kidney and liver [See Warnings and Precautions (5.7)]Pediatric patients (<18 years).2 DOSAGE AND ADMINISTRATIONPatients receiving Zortress may require dose adjustments based on everolimus blood concentrations achieved, tolerability, individual response, change in concomitant medications and the clinical situation. Optimally, dose adjustments of Zortress should be based on trough concentrations obtained 4 or 5 days after a previous dosing change. Dose adjustment is required if the trough concentration is below 3 ng/mL. The total daily dose of Zortress should be doubled using the available tablet strengths (0.25 mg, 0.5 mg or 0.75 mg). Dose adjustment is also required if the trough concentration is >8ng/mL on 2 consecutive measures; the dose of Zortress® should be decreased by 0.25 mg b.i.d. [See Therapeutic Drug Monitoring (2.3) and Clinical Pharmacology (12.3)]2.1 Dosage in Adult Kidney Transplant PatientsAn initial Zortress dose of 0.75 mg orally twice daily (1.5 mg per day) is recommended for adult kidney transplant patients in combination with reduced dose cyclosporine, administered as soon as possible after transplantation. [See Therapeutic Drug Monitoring (2.3, 2.4), Clinical Studies (14.1)]Oral prednisone should be initiated once oral medication is tolerated. Steroid doses may be further tapered on an individualized basis depending on the clinical status of patient and function of graft.2.2 Dosage in Adult Liver Transplant PatientsStart Zortress at least 30 days post-transplant. An initial dose of 1.0 mg orally twice daily (2.0 mg per day) is recommended for adult liver transplant patients in combination with reduced dose tacrolimus. [See Therapeutic Drug Monitoring (2.3 and 2.5), Clinical Studies (14.2)]Steroid doses may be further tapered on an individualized basis depending on the clinical status of patient and function of graft.2.3 Therapeutic Drug Monitoring -EverolimusRoutine everolimus whole blood therapeutic drug concentration monitoring is recommended for all patients. The recommended everolimus therapeutic range is 3 to 8 ng/mL. [See Clinical Pharmacology (12.7)] Careful attention should be made to clinical signs and symptoms, tissue biopsies, and laboratory parameters. It is important to monitor everolimus blood concentrations, in patients with hepatic impairment, during concomitant administration of CYP3A4 inducers or inhibitors, when switching cyclosporine formulations and/or when cyclosporine dosing is reduced according to recommended target concentrations. [See Clinical Pharmacology (12.7, 12.8)]There is an interaction of cyclosporine on everolimus, and consequently, everolimus concentrations may decrease if cyclosporine exposure is reduced. There is little to no pharmacokinetic interaction of tacrolimus on everolimus, and thus, everolimus concentrations do not decrease if the tacrolimus exposure is reduced. [See Drug Interactions (7.2)]The everolimus recommended therapeutic range of 3 to 8 ng/mL is based on an LC/MS/MS assay method. Currently in clinical practice, everolimus whole blood trough concentrations may be measured by chromatographic or immunoassay methodologies. Because the measured everolimus whole blood trough concentrations depend on the assay used, individual patient sample concentration values from different assays may not be interchangeable. Consideration of assay results must be made with knowledge of the specific assay used. Therefore, communication should be maintained with the laboratory performing the assay.2.4 Therapeutic Drug Monitoring-Cyclosporine in Kidney Transplant PatientsBoth cyclosporine doses and the target range for whole blood trough concentrations should be reduced, when given in a regimen with Zortress, in order to minimize the risk of nephrotoxicity. [See Warnings and Precautions (5.6), Drug Interactions (7.2), Clinical Pharmacology (12.8)]The recommended cyclosporine therapeutic ranges when administered with Zortress are 100 to 200 ng/mL through Month 1 post-transplant, 75 to 150 ng/mL at Months 2 and 3 post-transplant, 50 to 100 ng/mL at Month 4 post-transplant, and 25 to 50 ng/mL from Month 6 through Month 12 post-transplant. The median trough concentrations observed in the clinical trial ranged between 161 to 185 ng/mL through Month 1 post-transplant and between 111 to 140 ng/mL at Months 2 and 3 post-transplant. The median trough concentration was 99 ng/mL at Month 4 post-transplant and ranged between 46 to 75 ng/mL from Months 6 through Month 12 post-transplant. [See Clinical Pharmacology (12.8) and Clinical Studies (14.1)] Cyclosporine, USP Modified is to be administered as oral capsules twice daily unless cyclosporine oral solution or intravenous administration of cyclosporine cannot be avoided. Cyclosporine, USP Modified should be initiated as soon as possible -and no later than 48 hours -after reperfusion of the graft and dose adjusted to target concentrations from Day 5 onwards.If impairment of renal function is progressive the treatment regimen should be adjusted. In renal transplant patients, the cyclosporine dose should be based on cyclosporine whole blood trough concentrations. [See Clinical Pharmacology (12.8)]In renal transplantation, there are limited data regarding dosing Zortress with reduced cyclosporine trough concentrations of 25 to 50 ng/mL after 12 months. Zortress has not been evaluated in clinical trials with other formulations ofcyclosporine. Prior to dose reduction of cyclosporine it should be ascertained that steady-state everolimus whole blood trough concentration is at least 3 ng/mL. There is an interaction of cyclosporine on everolimus, and consequently, everolimus concentrations may decrease if cyclosporine exposure is reduced. [See Drug Interactions (7.2)]2.5 Therapeutic Drug Monitoring-Tacrolimus in Liver Transplant PatientsBoth tacrolimus doses and the target range for whole blood trough concentrations should be reduced, when given in a regimen with Zortress, in order to minimize the potential risk of nephrotoxicity. [See Warnings and Precautions (5.6), Clinical Pharmacology (12.9)]The recommended tacrolimus therapeutic range when administered with Zortress are whole blood trough (C-0h) concentrations of 3 to 5 ng/mL by three weeks after the first dose of Zortress (approximately Month 2) and through Month 12 post transplant.The median tacrolimus trough concentrations observed in the clinical trial ranged between 8.6 to 9.5 ng/mL at Weeks 2 and 4 post-transplant (prior to initiation of everolimus). The median tacrolimus trough concentrations ranged between 7 to 8.1 ng/mL at Weeks 5 and 6 post-transplant, between 5.2 to 5.6 ng/mL at Months 2 and 3 post-transplant, and between 4.3 to 4.9 ng/mL between Months 4 and 12 post-transplant. [See Clinical Pharmacology (12.9), Clinical Studies (14.2)] Tacrolimus is to be administered as oral capsules twice daily unless intravenous administration of tacrolimus cannot be avoided.In liver transplant patients, the tacrolimus dose should be based on tacrolimus whole blood trough concentrations. [See Clinical Pharmacology (12.9)]In liver transplantation, there are limited data regarding dosing Zortress with reduced tacrolimus trough concentrations of 3 to 5 ng/mL after 12 months. Prior to dose reduction of tacrolimus it should be ascertained that the steady-state everolimus whole blood trough concentration is at least 3 ng/mL. Unlike the interaction between cyclosporine and everolimus, tacrolimus does not affect everolimus trough concentrations, and consequently, everolimus concentrations do not decrease if the tacrolimus exposure is reduced.2.6 AdministrationZortress tablets should be swallowed whole with a glass of water and not crushed before use.Administer Zortress consistently approximately 12 hours apart with or without food to minimize variability in absorption and at the same time as cyclosporine or tacrolimus. [See Clinical Pharmacology (12.3)]2.7 Hepatic ImpairmentWhole blood trough concentrations of everolimus should be closely monitored in patients with impaired hepatic function. For patients with mild hepatic impairment (Child-Pugh Class A), the initial daily dose should be reduced by approximately one-third of the normally recommended daily dose. For patients with moderate or severe hepatic impairment (Child-Pugh B or C), the initial daily dose should be reduced to approximately one-half of the normally recommended daily dose. Further dose adjustment and/or dose titration should be made if a patient’s whole blood trough concentration of everolimus, as measured by an LC/MS/MS assay, is not within the target trough concentration range of 3 to 8 ng/mL. [See Clinical Pharmacology (12.6)]3 DOSAGE FORMS AND STRENGTHSZortress is available as 0.25 mg, 0.5 mg, and 0.75 mg tablets.Table 1. Description of Zortress (everolimus) TabletsDosage Strength 0.25 mg 0.5 mg 0.75 mg Appearance White to yellowish, marbled, round, flat tablets with bevelled edgeImprint “C” on one side and “NVR”on the other “CH” on one side and“NVR” on the other“CL” on one side and“NVR” on the other4 CONTRAINDICATIONS4.1 Hypersensitivity ReactionsZortress is contraindicated in patients with known hypersensitivity to everolimus, sirolimus, or to components of the drug product.5 WARNINGS AND PRECAUTIONS5.1 Management of ImmunosuppressionOnly physicians experienced in management of systemic immunosuppressant therapy in transplantation should prescribe Zortress. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for the maintenance therapy should have complete information requisite for the follow-up of the patient. In limited data with the complete elimination of CNI (calcineurin inhibition), there was an increased risk of acute rejection.5.2 Lymphomas and Other MalignanciesPatients receiving immunosuppressants, including Zortress, are at increased risk of developing lymphomas and other malignancies, particularly of the skin. The risk appears to be related to the intensity and duration of immunosuppression rather than to the use of any specific agent.As usual for patients with increased risk for skin cancer, exposure to sunlight and ultraviolet light should be limited by wearing protective clothing and using a sunscreen with a high protection factor.5.3 Serious InfectionsPatients receiving immunosuppressants, including Zortress, are at increased risk of developing bacterial, viral, fungal, and protozoal infections, including opportunistic infections. [See Warnings and Precautions (5.13), Adverse Reactions (6.1, 6.2)] These infections may lead to serious, including fatal, outcomes. Because of the danger of over immunosuppression, which can cause increased susceptibility to infection, combination immunosuppressant therapy should be used with caution.Antimicrobial prophylaxis for Pneumocystis jiroveci (carinii) pneumonia and prophylaxis for cytomegalovirus (CMV) is recommended in transplant recipients.5.4 Kidney Graft ThrombosisAn increased risk of kidney arterial and venous thrombosis, resulting in graft loss, has been reported, usually within the first 30 days post-transplantation. [See Boxed Warning]5.5 Hepatic Artery ThrombosisMammalian target of rapamycin (mTOR) inhibitors are associated with an increase in hepatic artery thrombosis (HAT). Reported cases mostly have occurred within the first 30 days post-transplant and most also lead to graft loss or death. Therefore, Zortress should not be administered earlier than 30 days after liver transplant.5.6 Zortress and Calcineurin Inhibitor-Induced NephrotoxicityIn kidney transplant recipients, Zortress with standard dose cyclosporine increases the risk of nephrotoxicity resulting in a lower glomerular filtration rate. Reduced doses of cyclosporine are required for use in combination with Zortress in order to reduce renal dysfunction. [See Boxed Warning, Indications and Usage (1.1), Clinical Pharmacology (12.8)]In liver transplant recipients, Zortress has not been studied with standard dose tacrolimus. Reduced doses of tacrolimus should be used in combination with Zortress in order to minimize the potential risk of nephrotoxicity. [See Indications and Usage (1.2), Clinical Pharmacology (12.9)]Renal function should be monitored during the administration of Zortress. Consider switching to other immunosuppressive therapies if renal function does not improve after dose adjustments or if the dysfunction is thought to be drug related. Caution should be exercised when using other drugs which are known to impair renal function.5.7 Heart TransplantationIn a clinical trial of de novo heart transplant patients, Zortress in an immunosuppressive regimen with or without induction therapy, resulted in an increased mortality often associated with serious infections within the first three months post-transplantation compared to the control regimen. Use of Zortress in heart transplantation is not recommended.5.8 AngioedemaZortress has been associated with the development of angioedema. The concomitant use of Zortress with other drugs known to cause angioedema, such as angiotensin converting enzyme (ACE) inhibitors may increase the risk of developing angioedema.5.9 Wound Healing and Fluid AccumulationZortress increases the risk of delayed wound healing and increases the occurrence of wound-related complications like wound dehiscence, wound infection, incisional hernia, lymphocele and seroma. These wound-related complications may require more surgical intervention. Generalized fluid accumulation, including peripheral edema (e.g., lymphoedema) and other types of localized fluid collection, such as pericardial and pleural effusions and ascites have also been reported.5.10 Interstitial Lung Disease/Non-Infectious PneumonitisA diagnosis of interstitial lung disease (ILD) should be considered in patients presenting with symptoms consistent with infectious pneumonia but not responding to antibiotic therapy and in whom infectious, neoplastic and other non-drug causes have been ruled-out through appropriate investigations. Cases of ILD, implying lung intraparenchymal inflammation (pneumonitis) and/or fibrosis of non-infectious etiology, some reported with pulmonary hypertension (including pulmonary arterial hypertension [PAH]) as a secondary event, have occurred in patients receiving rapamycins and their derivatives, including Zortress. Most cases generally resolve on drug interruption with or without glucocorticoid therapy. However, fatal cases have also occurred.5.11 HyperlipidemiaIncreased serum cholesterol and triglycerides, requiring the need for anti-lipid therapy, have been reported to occur following initiation of Zortress and the risk of hyperlipidemia is increased with higher everolimus whole blood trough concentrations. [See Adverse Reactions (6.2)] Use of anti-lipid therapy may not normalize lipid levels in patients receiving Zortress.Any patient who is administered Zortress should be monitored for hyperlipidemia. If detected, interventions, such as diet, exercise, and lipid-lowering agents should be initiated as outlined by the National Cholesterol Education Program guidelines. The risk/benefit should be considered in patients with established hyperlipidemia before initiating an immunosuppressive regimen containing Zortress. Similarly, the risk/benefit of continued Zortress therapy should be reevaluated in patients with severe refractory hyperlipidemia. Zortress has not been studied in patients with baseline cholesterol levels >350 mg/dL.Due to an interaction with cyclosporine, clinical trials of Zortress and cyclosporine in kidney transplant patients strongly discouraged patients from receiving the HMG-CoA reductase inhibitors simvastatin and lovastatin. During Zortress therapy with cyclosporine, patients administered an HMG-CoA reductase inhibitor and/or fibrate should be monitored for the possible development of rhabdomyolysis and other adverse effects, as described in the respective labeling for these agents. [See Drug Interactions (7.7)]5.12 ProteinuriaThe use of Zortress in transplant patients has been associated with increased proteinuria. The risk of proteinuria increased with higher everolimus whole blood trough concentrations. Patients receiving Zortress should be monitored for proteinuria. [See Adverse Reactions (6.2)]5.13 Polyoma Virus InfectionsPatients receiving immunosuppressants, including Zortress, are at increased risk for opportunistic infections; including polyoma virus infections. Polyoma virus infections in transplant patients may have serious, and sometimes fatal, outcomes. These include polyoma virus-associated nephropathy (PVAN), mostly due to BK virus infection, and JC virus associated progressive multiple leukoencephalopathy (PML). PVAN has been observed in patients receiving immunosuppressants, including Zortress. PVAN is associated with serious outcomes; including deteriorating renal function and kidney graft loss. [See Adverse Reactions (6.2)] Patient monitoring may help detect patients at risk for PVAN. Reductions in immunosuppression should be considered for patients who develop evidence of PVAN or PML. Physicians should also consider the risk that reduced immunosuppression represents to the functioning allograft.5.14 Interaction with Strong Inhibitors and Inducers of CYP3A4Co-administration of Zortress with strong CYP3A4-inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, boceprevir, telaprevir) and strong CYP3A4 inducers (e.g., rifampin, rifabutin) is not recommended without close monitoring of everolimus whole blood trough concentrations. [See Drug Interactions (7)]。

北京诺华制药双氯芬酸钾片说明书

核准和修改日期双氯芬酸钾片说明书请仔细阅读说明书并在医师指导下使用药物名称】【药物名称药物名称通用名称：双氯芬酸钾片商品名称：扶他捷®英文名称： Diclofenac Potassium Tablets汉语拼音：Shuanglüfensuanjia Pian成份】【成份成份活性成份：双氯芬酸钾化学名称：邻-（2，6-二氯苯胺基）-苯乙酸钾化学结构式：分子式：C14H10Cl2NKO2分子量：334.25】性状】【性状本品为糖衣片，除去糖衣后显白色。

】适应症】【适应症用于下列急症的短期治疗：- 创伤后疼痛、炎症和肿胀。

例如：扭伤。

- 手术后疼痛、炎症和肿胀。

例如：牙科及矫形手术后。

- 妇产科疼痛和/或炎症。

例如：原发性痛经或附件炎。

- 脊柱疼痛综合症。

- 非关节性风湿病。

- 偏头痛发作。

- 作为耳鼻喉科严重感染性痛性炎症的辅助治疗。

例如：咽扁桃体炎、耳炎。

按常规治疗原则，原发疾病应给予适当的基础治疗。

对单纯性发热的患者不适用。

【规格规格】】25mg【用法用量用法用量】】通常建议根据个体调整剂量，并在最短时间内给予最小有效剂量。

此药宜在饭前服用，用水整片送下，不可掰开或咀嚼。

成人成人：：推荐起始日剂量为100-150mg ，对轻度病人每日剂量为75-100mg ，通常将每日剂量分2-3次服用。

对原发性痛经，每日剂量应按不同情况区别对待，一般为50-150mg 。

最初剂量应为50-100mg ，必要时，可在若干个月经周期内提高剂量达到最大剂量200mg/日。

在最初症状出现时开始治疗，并根据症状连续治疗几天。

治疗偏头痛的起始剂量为50mg 并应在即将发作的第一症状出现时服用，如果首次服药后2小时内对疼痛缓解不满意，可再服用50mg 。

如果需要，每间隔4-6小时可服用50mg 双氯芬酸钾，但在任何24小时期间内总剂量不能超过200mg 。

儿童及青少年：不推荐儿童以及14岁以下的青少年使用双氯芬酸钾片剂，上述患者可以使用其他形式的双氯芬酸制剂，如口腔滴剂或栓剂。

全球二十强制药企业

全球二十大制药企业1.辉瑞公司•是一家拥有150多年历史的以研发为基础的跨国制药公司。

辉瑞制药有限公司拥有世界上最先进的生产设施和检测技术，其一流的检测分析手段及其完美的质量保障体系，使公司的产品全部达到或超过了中国药典和美国药典标准，且公司产品获准出口日本、澳大利亚、菲律宾及欧洲等地。

目前，在中国上市的产品包括：先锋必、舒普深、希舒美，大扶康，络活喜、左洛复、瑞易宁、万艾可、西乐葆、立普妥等。

•二十世纪80年代，伴随着中国改革的发展，辉瑞进入到中国市场，从此开始了长期投身于中国医药卫生事业发展的历程。

辉瑞在中国的业务包括人用药品、胶囊、以及动物保健三大领域。

大连辉瑞制药有限公司是由美国辉瑞公司与大连制药厂于1989年合资建成的大型现代化制药企业。

•公司网址/about/2.强生•始建于1886年，美国新泽西洲，至今公司总部仍没有迁址。

•强生成为第一家创造无菌外科敷料的公司，并创造了市场销售量快速增长的奇迹。

•强生邦迪创口贴在1920年问世，由一名叫作迪克逊的强生员工发明，起初他只是作为自己平日炊事发生小创伤时备用，后来成为了强生世界闻名的消费产品。

至今，强生邦迪创口贴生产量已经超过一千亿片。

•强生婴儿爽身粉生产于1893年，是强生著名世界性消费品之一。

•强生的医药设备创新、市场销售与发展速度皆在世界同行业领域中遥遥领先。

•强生视力健商贸有限公司是世界隐形眼镜生产的领导者。

•1985 年，强生在中国成立了第一家合资企业——西安杨森制药有限公司，生产药品。

随后，分别于1992年、1994年,1995年和1996年，成立了强生（中国）有限公司、强生（中国）医疗器材有限公司、上海强生制药有限公司，与强生视力健商贸（上海）有限公司共同组合成为强生在中国一个庞大而温暖的家庭。

•公司网址/connect/3.赛诺菲-安万特•赛诺菲-安万特集团是世界第三大制药公司，在欧洲排名第一。

其业务遍布世界100多个国家，现拥有约11，000名科学家及100，000名服务于健康事业的员工。

诺华创新药密固达正式进入中国市场

诺华创新药密固达正式进入中国市场
佚名
【期刊名称】《中国当代医药》
【年(卷),期】2009(16)19
【摘要】本刊讯作为全球性健康问题之一，骨质疏松症的严重性仅次于心脑血管疾病，其发病率在我国老年人群中已有日渐攀升之势。

北京诺华制药有限公司日前宣布，一年给药一次的创新药物密固达（唑来膦酸注射液）正式进入中国市场。

将全面提升骨密度，降低骨折风险，造福中国广大骨质疏松症患者。

【总页数】1页(P106-106)
【关键词】中国市场;创新药物;全球性健康问题;唑来膦酸注射液;骨质疏松症;心脑血管疾病;老年人群;骨折风险
【正文语种】中文
【中图分类】R452;R95
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3.瑞士诺华抗癌新药"美妇乐"获准进入美国市场 [J],
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因版权原因，仅展示原文概要，查看原文内容请购买。

诺华:成长是最好的激励

诺华：成长是最好的激励
刘戈
【期刊名称】《中外管理》
【年(卷),期】2008(000)011
【摘要】@@ 在"CCTV年度雇主调查"发布晚会上,每家获得年度最佳雇主的企业都要从我们准备的十首歌曲中选择一首,以歌名为题进行主题演讲.诺华中国总裁李振福先生毫不犹豫地选择了<隐形的翅膀>这首歌.李振福给这首著名的励志歌曲一个新的诠释:对员工的培养,就是给他们插上的隐形翅膀.
【总页数】2页(P68-69)
【作者】刘戈
【作者单位】CCTV经济频道
【正文语种】中文
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2.中国科协激励青年成长服务创新战略弘扬科学精神激励人才成长 [J], 付毅飞
3.研究是教师最好的成长——读《从新手到研究型教师:我的专业成长手记》有感[J], 曾建洪
4.苏州五中：激励学生成长为最好的自己 [J],
5.最好的教材最好的成长 [J], 穆瑞杰
因版权原因，仅展示原文概要，查看原文内容请购买。

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诺华
http://www.novartis.com.cn
1996年3月7日，瑞士两大化学/生命科学巨头山德士公司 (Sandoz) 和汽巴-嘉基公
司 (Ciba-Geigy) 合并为现在的诺华 (Novartis)。诺华在北京和上海有六家企业和一家综合研
发中心，总投资超过3.3亿美元，目前诺华在中国雇员将近3,000人。2007诺华在中国的总
销售额达到25.8亿人民币。
产品领域：诺华在11大疾病领域拥有丰富的制药产品
心血管 ›
抗肿瘤/血液学 ›
骨代谢 ›
皮肤科 ›
内分泌 ›
移植及自身免疫力 ›
眼科 ›
抗感染 ›
抗风湿/疼痛 ›
中枢神经系统 ›

眼科
作为诺华的又一突破性创新产品，维速达尔是治疗湿性老年性黄斑变性引起的脉络膜新生血
管的核心药物。维速达尔是被美国FDA批准的唯一用于眼科治疗的光敏剂。未来，诺华还
将在中国上市新一代抗血管生成药物——Lucentis。维速达尔将和Lucentis一起成为眼底疾
病治疗领域的领导者。

诺沛凝胶
第五代人工泪液，是目前唯一含有维生素A 的角膜保护凝胶，治疗各种干眼症，促进角结
膜损伤的愈合，缓解配戴隐形眼镜后引起的眼部不适。

维速达尔（维替泊芬静脉输液冻干粉）
目前公认的最有效和安全的光动力疗法光敏剂，通过光动力疗法治疗湿性老年性黄斑变性、
病理性近视眼、眼组织胞浆病等导致的黄斑中心凹下脉络膜新生血管等引起视力持续恶化或
丧失的疾病
易妥芬滴眼液（硫酸庆大霉素/氟米龙滴眼液）
是安全高效的激素与抗生素复方制剂，用于细菌性角结膜炎、眼前段炎症及眼科术后治疗。