A |
B | Joran van der Sloot, the main suspect in the 2005 disappearance of Natalee Holloway, pleaded guilty Wednesday to federal extortion charges related to the Alabama teenager's disappearance and was sentenced to 20 years in prison.As a part of the plea deal, van der Sloot agreed to provide information about the 18-year-old's disappearance in Aruba to Holloway's mother, Beth Holloway.Van der Sloot said he killed Natalee Holloway on a beach, bludgeoned her face with a cinderblock and then disposed of her body in the ocean, according to a partial transcript of a proffer meeting he had with prosecutors on Oct. 3.Van der Sloot said Natalee Holloway had wanted to go back to her hotel that night, but he arranged for the two to get dropped off "a little bit further away from her hotel so we could walk back … and I might still get a chance to be with her," van der Sloot said in the meeting with prosecutors.As the two walked alone on the beach, van der Sloot said he "laid her down" and they began kissing, and then Holloway told him to stop.But he said he kept pursing her, and Natalee Holloway "knees me in the crotch," van der Sloot said, according to the transcript."When she knees me in the crotch I get up on the beach and I kick her extremely hard in the face," he continued.He said the teen was then "laying down unconscious, possibly even dead," according to the transcript.Van der Sloot told prosecutors he then found a cinderblock on the beach and "smashed" her head with it.He said he walked into the ocean up to his knees and pushed Natalee Holloway's body into the water.In court Wednesday, as van der Sloot pleaded guilty to federal extortion charges, Beth Holloway said, "Joran, for 18 years you denied killing my daughter," and now "you have finally admitted that you, in fact, have murdered her.""You are a killer. I want you to remember that every time that jail door slams," she said."Even if you have finally confessed ... you can't be tried here for her murder. But I do employ the court to give you the maximum sentence possible," Beth Holloway said.Turning to van der Sloot, she added, "By the way, you look like hell, Joran. I don't know how you are going to make it."She left the podium in tears.Van der Sloot, 36, apologized in court to the Holloway family and his own family, and said he hopes "the statement that I provided will provide some kind of closure.""I am not the same kind of person today as I was then, I have given my heart to Jesus Christ," he said.Natalee Holloway's dad, Dave Holloway, said in a statement, "Today's proceeding confirmed that this defendant murdered Natalee and then tortured and extorted those who loved her most.""He is evil personified," Dave Holloway said.The judge Wednesday accepted the plea agreement and said van der Sloot brutally murdered two young women who refused his sexual advances, but that his confession in the Natalee Holloway case cannot be used against him.The judge sentenced van der Sloot to 20 years in prison to run concurrently with the Peruvian sentence. He will also have to pay restitution to Beth Holloway.Van der Sloot initially pleaded not guilty to the extortion and wire fraud charges in June after he was extradited to the U.S. from Peru, where he had been serving a 28-year sentence for the 2010 murder of 21-year-old Stephany Flores.In 2010, van der Sloot was indicted by a federal grand jury for allegedly trying to extort Holloway's family.Federal prosecutors alleged that in March 2010 van der Sloot contacted Beth Holloway through her lawyer, John Q. Kelly, and claimed he would reveal the location of the teen's body in exchange for $250,000, with $25,000 paid upfront. During a recorded sting operation, Kelly met with van der Sloot at an Aruba hotel, giving him $10,000 in cash as Beth Holloway wired $15,000 to van der Sloot's bank account, according to prosecutors.Then, van der Sloot allegedly changed his story about the night he was with Natalee Holloway, prosecutors said. Van der Sloot claimed he had picked Natalee Holloway up, but she demanded to be put down, so he threw her to the ground. Van der Sloot said her head hit a rock and he claimed she died instantly from the impact, according to prosecutors.Van der Sloot then took Kelly to a house and claimed that his father, who had since died, buried Natalee Holloway in the building's foundation, prosecutors said.Kelly later emailed van der Sloot, saying the information he had provided was "worthless," according to prosecutors. Within days, van der Sloot left Aruba for Peru.After court ended Wednesday, Beth Holloway told reporters, "I got the answer I’ve been searching for for the last 18 years. ... For me, reaching the end of the nightmare is better than closure."ABC News' Miles Cohen contributed to this report.。
C | 华安证券方面从A股中抽取了42家创新药公司的中报数据作为样本进行评析。
D | 结果显示，2022上半年，国内创新药板块营业总收入为1005.7亿元，同比微增2.36%，总研发费用则同比增长13.79%。
E | 《每日经济新闻》记者注意到，如果将创新药公司分为成熟药企和刚开始盈利或未盈利的Biotech两部分，在Biotech板块中，今年上半年营业收入最高的是百济神州（42.1亿元），收入增速最高的则是荣昌生物（1033%），收入中位数为2.29亿元，收入增速中位数为0。研发投入最高的Biotech同样是百济神州（50.16亿元），研发增速最高为125%，研发增速中位数为21%。
F |
G | 在国内市场，目前已有十四款PD-1/PD-L1单抗获批，分别涉及恒瑞医药、百济神州、君实生物、信达生物、康方生物、誉衡药业、复宏汉霖、康宁杰瑞、基石药业、乐普生物等上市企业。以PD-1四小龙（恒瑞医药、百济神州、君实生物、信达生物）为例，Wind数据显示，2022年上半年，四家企业合计实现营业收入176.24亿元，较去年同期222.45亿元的合计营收减少20.77%；合计实现归母净利润-64.07亿元，相比去年同期净亏损有所扩大；四家企业的研发支出则合计达到94.37亿元。具体来看，恒瑞医药上半年营收为102.28亿元，同比下降23.08%；归母净利润为21.19亿元，同比下滑20.55%。面对罕见的营收利润双降，公司在半年报中解释称，其业绩下滑主要受集采、医保谈判和部分地区疫情反复等多重因素影响。传统仿制药受到冲击，创新药放量不及预期，或是恒瑞医药交出“史上最差”半年报成绩单的主要原因。实际上，市场对于恒瑞医药的业绩增长失速也早有预期。财报显示，从2021年第二季度到2022年第二季度，恒瑞医药已面临业绩承压的挑战，上述期间，恒瑞医药的单季度归母净利润同比下滑幅度分别为13.03%、3.57%、84.39%、17.35%以及24.65%。恒瑞医药的营收则是从2021年第三季度开始出现同比下滑，公司营收单季度同比下滑幅度分别为14.84%、31.42%、20.93%及25.42%。
H | 在PD-1产品上已有5项适应症被纳入国家医保目录的百济神州则是四家企业中业绩相对亮眼的一个。今年上半年，百济神州的两款自研产品PD-1抗体药物百泽安（替雷利珠单抗注射液）和BTK抑制剂百悦泽（泽布替尼胶囊）的吸金能力较上年同期显著提升，共实现产品收入36.76亿元，较上年同期上升132.2%。其中，替雷利珠单抗在中国市场的销售额为12.51亿元，相比较于上年同期的8亿元增长近56.37%。医保报销范围扩大带来的新增患者需求持续推动替雷利珠单抗在已获批适应症的市场渗透率和市场份额的扩大。另外，根据8月26日信达生物发布的2022财年中报数据，公司报告期内营业收入同比增长15.34%。而在PD-1产品信迪利单抗的销售业绩上，根据礼来方面的披露，2022年上半年信迪利单抗在中国市场的收入合计为1.59亿美元，较上年同期的2.15亿美元下降近三成，信迪利单抗已在与替雷利珠单抗的交锋中稍逊一筹。信达生物在半年报中称，尽管信迪利单抗因纳入最新国家医保目录价格降幅明显，但产品销量快速增长且新产品的收入贡献日益增加仍然驱动产品收入的整体增长。然而，由于中国部分地区新冠疫情反复等情况，对产品收入的增长率有所影响。作为国产首款获批的PD-1，君实生物的特瑞普利单抗却在与其余三家PD-1的竞争中被拉开了显著差距。
I | 2021年年报显示，PD-1特瑞普利单抗去年营业收入共计4.12亿元，同比下降58.96%，较2020年的10.03亿元减少了近6亿元，这也是特瑞普利单抗自2018年底获批以来年销售额最低的一年。横向对比看，在国产PD-1“四小龙”中，君实生物特瑞普利单抗的销售收入也处于垫底位置。8月30日，君实生物披露了2022年上半年业绩报告，报告期内实现收入9.46亿元，同比下降55.26%，这是因为去年新冠中和抗体埃特司韦单抗与礼来制药合作，产生大额技术许可收入及特许权收入，而今年没有相关的一次性收益。君实生物归母净利润由盈转亏，从去年同期的盈利934.7万元转为大幅亏损9.12亿元。此外，其PD-1抗体特瑞普利单抗上半年销售收入为2.98亿元，其中2022年第一季度较2021年第四季度环比提升212%，即使受到4月、5月部分地区疫情影响，其第二季度销售较第一季度环比提升70%。从销售数据上可以看到，自去年11月公司任命李聪为公司联席首席执行官，全面负责商业化领域相关工作以来，特瑞普利单抗在国内市场的销售活动逐步走出低谷。不过，考虑到目前与其余三家PD-1产品在销量上的差距，特瑞普利单抗未来能否实现销售放量依然有待市场检验。另外获批的四款国产PD-1中，来自康方生物的派安普利单抗，今年上半年销售业绩近2.97亿元，与君实生物已相差无几；复宏汉霖的斯鲁利单抗在上市三个月中就卖了7690万元，誉衡药业的赛帕利单抗暂未披露相关数据，乐普生物的普特利单抗由于今年7月才获得批准，上半年并未产生销售收入。创新药进入下半场 企业如何度过寒冬?面对业绩困境，恒瑞医药也不得不断臂求生。公司销售费用也在下降，今年上半年公司销售费用为32.67亿元，同比下降近三成。尽管处于由“仿”入“创”的阵痛期，恒瑞医药仍坚定加大研发投入。
J | 报告期内，公司累计研发投入达到29.09亿元，同比增加12.74%，研发投入占销售收入的比重同比提升至28.44%，其中费用化研发投入21.84亿元，研发费用占销售收入比重同比提升至21.36%。在研发上投入最多的还要属百济神州，其上半年的研发费用高达50.16亿元，同比增加20.82%，在国内创新药企业中一骑绝尘。
K | 百济神州表示，之所以研发费用高，是因为在全球范围内，公司正在为超过40种药物和候选药物执行近80项正在进行或已计划的临床试验。也正是由于真金白银砸出来的研发能力，今年上半年，替雷利珠单抗在国内新增获批3项适应症，由此共计9项适应症取得批准，成为国内市场上获批治疗适应症最多的抗PD-1单抗。对于PD-1市场的竞争，不少业内观点认为“得适应症者得天下”，替雷利珠单抗未来销量有望进一步放量。
L | 信达生物中报显示，公司上半年研发开支达11.74亿元，同比增加20.54%，公司称，“稳定上升的研发开支，主要用于公司全球在研管线中处于开发后期阶段的产品及优先开发产品的临床试验，以进一步扩大公司现有产品系列的适应症，以及开发公司在研新药，包括临床前的项目开发。”管线进展方面，报告期内信达生物已建立起34条管线。值得一提的是，上半年公司有7个产品获得批准上市，3个品种在NMPA审评中，4个品种进入III期或关键性临床研究，另有20个产品已进入临床研究。
M | 君实生物同样在持续扩大研发规模，其上半年研发投入共计10.62亿元，同比增长12.14%。截至6月末，君实生物处于商业化阶段的在研产品3项，近30项在研产品处于临床试验阶段，超过20项在研产品处在临床前开发阶段。但与此同时，君实生物目前较弱的造血能力也使其更为依赖外部融资，今年3月，君实生物发布定增募资预案，由于融资数额逼近40亿元，该募资计划一经发布便引发市场关注。在定增募资预案发布半年后，君实生物于9月2日发布定增方案的申报稿。申报稿显示，君实生物此次发行股票数量不超7000万股，募集资金总额（含发行费用）不超39.69亿元。
N | 其中，36.71亿元拟用于创新药研发项目，2.98亿元拟用于上海君实生物科技总部及研发基地项目。对此，有投资人质疑，在“创新药寒冬”背景下，其他创新药公司都在收缩管线、控费增效，君实生物这笔涉及近40亿元的定增计划被认为是“逆势”启动。不过，君实生物董秘陈英格此前在接受记者采访时表示，“逆势”不一定是一个贬义词，相反对于Biotech公司而言，顺势扩张反而往往会导致泡沫堆积、增加风险。“但如果别人都在因为一些迫不得已的原因而收缩，我们的手上这时候如果能再多一些‘子弹’，让公司在竞争中获得优势并且拉开差距，对于企业的中长期发展会有非常大的助力。
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