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282021.04
What changes have been brought about by the Criminal Law Amendment "Severe Crackdown" on Securities Violations? Expert interpretation is here

The Criminal Law Amendment (11) (hereinafter referred to as the Amendment) was reviewed and passed, filling the shortcomings of the system, and the securities law resonated with the criminal law. A shares will usher in the era of "dual law in one".

The amendments significantly increase the penalties for fraudulent issuance, information disclosure falsification and other crimes, and strengthen the criminal responsibility of “key minorities” such as controlling shareholders and actual controllers. In addition, it also clearly sets sponsors as providing false certifications The criminal subject of the crime of document crimes and the crime of major misrepresentation of documents issued shall be investigated for criminal responsibility for this crime.

The "Daily Business News" reporter interviewed a number of economists, secretaries of listed companies, intermediary agencies, and lawyers. They pointed out that the amendments superimposed on the new "Securities Law" will put a heavy emphasis on fraudulent activities in the capital market and greatly deter potential violations. By.

   The reporter interviewed a number of interviewees and learned that the amendment involves criminal prosecutions for violations in the capital market. Then this requires a prosecution standard. Which type of information disclosure fraud should be penalized? What kind of behavior is a very serious form of false disclosure?

   On December 26, the official website of the China Securities Regulatory Commission also stated that in the next step, it will take the opportunity to implement the Criminal Law Amendment (11) as an opportunity to accelerate the revision and improvement of criminal prosecution standards.

Unlimited personal fines for fraud

   On December 26, the Twenty-Fourth Meeting of the 13th National People's Congress passed the Criminal Law Amendment (11), which will be officially implemented on March 1, 2021.

   This amendment has triggered a enthusiastic response from the capital market, and several key points have attracted attention.

   First, the amount of penalties for violations of laws and regulations has been greatly increased, and personal fines are even unlimited. For example, the personal penalty for fraudulent issuance was changed from 1% to 5% of illegally raised funds to "combined penalty", the 5% upper limit was removed, and the penalty for units was increased from 1% to 5% of illegally raised funds to 20%~ 1 times; the amount of fines for the responsible person was revised from 20,000 to 200,000 yuan to "combined fines" for information disclosure fraud, and the upper limit of 200,000 yuan was cancelled;

   The second is that market entities are penalized for fraud, with an upper limit of up to 10 years, and it also covers intermediary agencies such as lawyers, accountants, and sponsors. The amendment raises the upper limit of the sentence for persons responsible for information disclosure and falsification from 3 years to 10 years. In situations where lawyers, accountants, and other intermediary agencies issue false certification documents in securities issuance or major asset trading activities, and the circumstances are particularly serious, a higher sentence is clearly applicable, and the maximum sentence is 10 years in prison.

   Again, it is to strengthen the criminal accountability of the "critical minority" of listed companies. The controlling shareholder, actual controller organization, instigation of fraudulent issuance, information disclosure falsification, and the controlling shareholder and actual controller concealing related matters leading to the company's disclosure of false information, etc. are included in the scope of criminal laws and regulations.

   Finally, it is to further clarify the criminal responsibility for new market manipulations such as "fraud trading manipulation", "deceitful transaction manipulation", and "capture manipulation".

   The "Daily Business News" reporter interviewed a number of economists, secretaries of listed companies, intermediaries, and lawyers. They stated that the amendment is of great significance to maintaining market order, advancing the reform of the registration system, and ensuring the stable and healthy development of the capital market.

  In fact, this is the system construction of "top-level design". Following the implementation of the new "Securities Law", the penalty of fraud will correct the low cost of illegal capital market violations in the past. In the eyes of many securities lawyers, the amendments to the criminal law are parallel to the new Securities Law, and A shares will also be escorted by the "dual law in one".

"From the previous situation, the amendment to the Securities Law has become a sharp sword, and this amendment can be said to be a'shangfang sword'." A listed company secretary said that IPO fraud will be effectively curbed. .

Economist Song Qinghui believes that the amendment is a boost to the healthy development

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What changes have been brought about by the Criminal Law Amendment "Severe Crackdown" on Securities Violations? Expert interpretation is here
252021.02
第四批集采“砍掉”124亿!扬子江、齐鲁、东阳光药……大丰收,诺华、辉瑞、AZ出局

1月15日,上海阳光医药采购网发布公告,第四批集采正式启动,2月3日开标。45个品种80个品规纳入此次集采,其中注射剂8个,滴眼剂3个,其余均为口服制剂。米内网数据显示,45个通用名药品在2019年中国公立医疗机构终端合计销售额550亿元,涉及最高采购规模超过250亿元,有9大品种采购额均超10亿元;超过120家企业可参与竞争,14个药品可参与竞争企业数达5家及以上,注射剂竞争激烈;齐鲁、扬子江领跑,12家企业可竞标品种数达3个及以上,勃林格殷格翰、诺华各有5个品种被盯上。

第四批集采45个通用名药品竞争格局



注:销售额低于3000万用*代表

      此前流传版本纳入44个品种90个品规,正式文件为45个品种80个品规。经比对,玻璃酸钠滴眼剂5ml:5mg (0.1%)、10ml:10mg (0.1%)与玻璃酸钠滴眼剂0.4ml:1.2mg (0.3%)分列为两个品种。此外,多索茶碱注射剂少了10ml:0.2g、20ml:0.3g两个规格、氯雷他定少了5mg规格、那格列奈口服常释剂型少了30mg规格、培哚普利少了2mg规格、羟苯磺酸少了0.25g规格、吸入用硫酸沙丁胺醇少了0.1g/20ml规格、替米沙坦少了20mg规格、头孢丙烯少了0.125g、0.5g两个规格。

      与第三批集采相比,第四批集采规则上没有太大变化,但是入围企业最多增加到10家;采购规模较大,第四批集采45个药品合计最高采购额超过250亿元,其中9个品种均超过10亿元,而第三批集采55个药品合计最高采购额226亿元,其中6个品种均超过10亿元;竞争情况相对缓和,第四批集采14个药品竞争企业数达5家及以上,第三批集采有22个药品竞争企业数达5家及以上。

550亿市场大地震,21个药品年销超10亿

      米内网数据显示,45个通用名药品在2019年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院(简称中国公立医疗机构)终端合计销售额550亿元,其中有21个药品销售额超过10亿元,泮托拉唑注射剂以66.7亿元领跑,氨溴索注射剂以59.8亿元紧接其后。

      布洛芬注射液、恩格列净口服常释剂型、恩曲他滨替诺福韦口服常释剂型、卡格列净口服常释剂型等药品因为上市时间比较晚,销售额较低,这也充分体现了国家集采对具备竞争条件的品种应采尽采的原则,药品销售额不再成为是否纳入集采的主要指标。

销售额超过10亿元的品种





      21个销售额超过10亿元的集采药品中,20个药品的原研厂家已获批进口。在2019年中国公立医疗机构终端竞争格局中,11个药品的原研厂家市场份额超过50%,其中缬沙坦氨氯地平Ⅰ口服常释剂型、索拉非尼口服常释剂型两个药品由原研厂家独占市场。这些品种销售基数大,仿制替代原研的效应将更加明显。

      在正式文件中,45个药品的采购规则、各地首年约定采购量、各采购品种首年约定采购量等内容均明确。根据各采购品种首年约定采购量及最高有效申报价,此次集采的45个药品涉及的最高采购规模超过250亿元,是这几次集采中采购规模比较大的一次。

      从各个药品的采购规模看,9个药品采购规模均超过10亿元,其中帕瑞昔布注射剂、氨溴索注射剂、多索茶碱注射剂、泮托拉唑注射剂竞争最为激烈,过评企业数量分别为12、12、5、4家。伏立康唑口服常释剂型、缬沙坦氨氯地平Ⅰ口服常释剂型过评企业数达3家,埃索美拉唑(艾司奥美拉唑)口服常释剂型、恩曲他滨替诺福韦口服常释剂型、替莫唑胺口服常释剂型过评企业数只有2家。

14个药品竞争激烈,3大千亿市场洗牌

第四批集采品种治疗领域分布情况



      45个药品涵盖10个治疗类别,涉及药品数量TOP3类别分别为神经系统药物、全身用抗感染药物、消化系统及代谢药,涉及的药品数量分别有9、8、6个。米内网数据显示,2019年中国公立医疗机构化学药终端神经系统药物、全身用抗感染药物、消化系统及代谢药三大治疗领域销售规模均超过1000亿元。三大治疗领域多个品种被纳入此次集采,将对其用药格局带来影响。

      从药品竞争情况看,45个药品均满足3家及以上的充分竞争条件,其中31个药品过评企业数达3家及以上(26个原研厂家已获批进口),14个药品过评企业数满2家,原研厂家均已获批进口。

满足条件企业数达5家及以上的药品



      与第三批集采相比,第四批集采竞争程度相对缓和。14个药品可参与竞争的企业数达5家及以上,氨溴索注射剂、帕瑞昔布注射剂竞争最激烈,满足门槛企业数达10家以上。随着注射剂一致性评价正式启动,过评企业数与日俱增,未来或成为集采的“主角”。

齐鲁、扬子江、石药……大展身手,BI、诺华5个品种被盯上

过评品种达3个及以上的企业(按集团计)(单位:个)



      第四批集采涉及45个品种,相比第三批集采56个品种,数量有所减少。据米内网统计,过评品种达3个及以上的企业有12家,齐鲁制药、扬子江药业均以7个过评品种领跑,中国生物制药、石药集团涉及的过评品种分别有6个、5个,豪森药业、科伦药业、东阳光药及复星医药均有4个过评品种在列,倍特药业、百奥药业、福元医药及恒瑞医药各有3个品种涉及。

      齐鲁制药素有“价格杀手”之称,在前面开展的三批四轮集采中,合计17个品种中标。值得一提的是,第三批集采齐鲁制药涉及的8个品种均中标。第四批集采齐鲁制药涉及的7个品种分别为氨磺必利片、注射用帕瑞昔布钠、注射用硼替佐米、普瑞巴林胶囊、盐酸特比萘芬片及注射用比伐芦定、盐酸普拉克索片,过评企业均达3家及以上,竞争的激烈可想而知。

      多家企业的品种是在2020年获批上市,市场尚待开拓。比如齐鲁制药的盐酸普拉克索片、普瑞巴林胶囊及注射用比伐芦定均于2020年获批上市;扬子江涉及的多索茶碱注射液、玻璃酸钠滴眼液于2020年获批上市,丙泊酚中/长链脂肪乳注射液于2021年获批;石药集团、中国生物制药等均有涉及品种是近几年刚获批上市,一旦中标集采将迅速打开市场,企业必然会积极参与竞标。

      据米内网统计,诺华和勃林格殷格翰均有5个品种被纳入第四批集采,辉瑞和阿斯利康均有3个品种涉及。45个品种中,21个品种的原研药企2019年在中国公立医疗机构终端占据的市场份额超过50%,其中7个品种由原研药企独占市场,且索拉非尼口服常释剂型、缬沙坦氨氯地平Ⅰ口服常释剂型销售额超过10亿元,原研药企会否积极竞标值得关注。

入选品种达3个及以上的原研药企(单位:个)



8款注射剂集采!6款注射剂年销超10亿

      注射剂是第四批集采的一大关注点。2020年5月,国家药监局发布《关于开展化学药品注射剂仿制药质量和疗效一致性评价工作的公告》,标志着化药注射剂一致性评价工作正式启动。2020年9月,国家集采将逐步注射剂比重的消息在业内流传。2020年10月,CDE发布《关于注射剂一致性评价补充资料相关事宜的通知》,意在提高注射剂一致性评价工作效率、优化审评审批流程。

      2020年是注射剂一致性评价的爆发年,注射剂过评数量与速度较以往大幅提升,为第四批集采提升注射剂比重做了铺垫。据米内网统计,2020年过评的注射剂有73个品种,不仅数量较前三年大幅增加,一致性评价补充申请也大开闸,以新注册分类报产不再是注射剂过评的主要方式,早期布局注射剂一致性评价的企业获益显著。

第四批集采注射剂品种竞争格局



      第一、二、三批集采涉及的注射剂品种分别有3个、1个、3个。相较前三批集采,第四批集采涉及的注射剂品种多达8个,数量创新高。8个注射剂分别为盐酸氨溴索注射液、丙泊酚中/长链脂肪乳注射液、布洛芬注射液、多索茶碱注射液、注射用帕瑞昔布钠、注射用泮托拉唑钠、注射用硼替佐米及注射用比伐芦定。其中6个注射剂2019年在中国公立医疗机构终端销售额超过10亿元,且氨溴索注射剂、泮托拉唑注射剂销售额分别超过50亿元、60亿元。

      8款注射剂过评企业均达3家及以上,盐酸氨溴索注射液、注射用帕瑞昔布钠这2款注射剂的过评企业高达12家,价格激战不可避免。多索茶碱注射液过评企业达5家,注射用泮托拉唑钠、布洛芬注射液、注射用硼替佐米过评企业均有4家。

来源:米内网数据库、上海阳光医药采购网

注:数据统计截至1月15日,如有疏漏,欢迎指正

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第四批集采“砍掉”124亿!扬子江、齐鲁、东阳光药……大丰收,诺华、辉瑞、AZ出局
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