国际药企巨头默沙东与合作伙伴发布了成功研发抗新冠病毒药片，该新闻瞬间登上各大媒体头条，连锁反应是默沙东的股票飙升，mRNA疫苗厂家的股市下跌。

就连国际顶级权威专家Dr. Anthony S. Fauci博士也发表评论该药“very impressive”。FDA没有给出任何评论。

自从疫情以来，几乎所有新冠疾病和疫情的研究结果总是最先通过新闻形式，公布于众，这已成为了新常态，没人在乎同行评议论文。

从临床医生角度看，口服药片molnupiravir与静脉给药抗病毒方法相比，具有绝对优势和便捷性。每天口服两次药片，持续五天一个疗程。轻中度感染患者或疑似感染的人都能做到。就像感冒初期喝几包板蓝根，休息几天呗！

但是，医界人士仍善意提醒“疫情期间有多少药都说抗新冠病毒，比如吉利德的瑞姆昔韦，就是最亮眼的忽悠案例(美赞“人民的希望”)。

实际上，根据目前公布的信息，专业人士尚不清楚这种抗病毒治疗是否能被广泛应用（首先需要获得FDA-EUA批准）。投资分析家也在预测这种抗新冠病毒药将产生多少亿美元销售额，是否会超过新冠疫苗的获益？

如果我们静心琢磨默沙东这款抗新冠病毒药molnupiravir，再对比其他药企在研的抗病毒药，包括中医抗病毒方剂(实战验证有效的)，仍有许多问题没有得到解答。

如果是针对轻中度新冠病毒感染疾病患者，值得临床专家开展“头对头”的临床试验，比较中药抗新冠病毒方剂和默沙东的抗病毒药molnupiravir。

唯一困惑的是中医抗新冠肺炎“处方剂”似乎太多、太多了，不知道选择哪个更具有代表性？

抗新冠病毒药如何被证明确有其效？

根据媒体报道，默沙东抗新冠病毒药molnupiravir之所以成功，重要原因之一是尽早给予抗病毒药，帮助轻中度感染患者或无症状患者不会发展成为重症。因此，可预测减少患者住院率50%（这也是临床观察终点?）。

被媒体称之为改变“游戏规则”的救命药molnupiravir能做到这一点很不容易了，而其他抗病毒药并没有展示出如此明确效果，比如瑞姆昔韦不仅需要静脉滴注三天给药，仅仅是缩短了住院病程时间(临床观察终点)。

molnupiravir安全性如何?

Obviously, a drug given early in Covid needs a clean safety profile. So far, the data included in the press release look very good.

Patients in the placebo arm were three times more likely to withdraw from the study due to apparent side effects than those who actually received molnupiravir. That likely means the side effects of Covid were worse than those of the drug.

But only so much can be seen from that kind of data. Molnupiravir works by messing up the way the virus copies RNA, its genetic material, preventing viral replication.

There is some concern it could be mutagenic, meaning that it could cause mutations. One result could be that it causes birth defects. In the clinical trial,both women and men were told to either abstain from sexual intercourse or to use contraceptionwhile they were taking the drug and for at least four days after. Women of child bearing age also needed a negative pregnancy test to start taking the medicine.

Could there be other effects?

In a conference call with reporters Friday, Daria Hazuda, a top Merck virologist, said that Merck and Ridgeback had studied the mutagenic potential of the drug in both cell lines and in animal models that are routinely used in drug development and which are accepted by regulatory agencies.

“I would say that in all of the models where we have looked, we have seen no evidence of the potential for mutagenicity for this agent,” Hazuda said.

“We’re very comfortable that the drug will be safe if used as intended and at the concentrations where we have looked and in the concentrations which we are achieving in patients.”

只有那些未接种疫苗的患者用molnupiravir?

Merck’s trial was conducted entirely in patients who had not been vaccinated. That made it much easier to show that the medicine can reduce hospitalization and death — because patients who have not previously been vaccinated are more likely to be hospitalized or die.

But does that mean that, in practice, the drug will only be used in unvaccinated patients, or will it be used in cases of breakthrough infections? It’s hard to say. Patients with breakthrough infections are at lower risk of hospitalization, which could change the risk-benefit calculus around the medicine.

该药未来市场规模预期有多大?

Daina Graybosch, an analyst at SVB Leerink, forecast in a note to investors on Monday morning that molnupiravir sales will peak near $5 billion a year in 2022.

Built into this are a number of assumptions, among them that the first-mover advantage will mean that Merck and Ridgeback will be used more than the other pills in development and that unvaccinated patients with breakthrough infections will be eligible to receive the drug, too.

Timothy Anderson of Wolfe Research, a stand alone equities research firm, takes the other side, essentially saying it is too soon to put a number on molnupiravir sales, in part because data from competing firms are not available but also because other questions remain.

“Vaccination rates continue to rise in the US and other developed markets, meaning the cohort of patients who would qualify for molnupiravir (i.e. mostly those who are unvaccinated, at higher risk) will shrink over time,” Anderson wrote in a note to clients.

Successfully using the drug, he pointed out, will also require that patients get tested early in their disease course. If people start to skip getting tested, they won’t receive molnupiravir.

该药品预期售价多少？谁付费？

Most analysts are basing the cost of molnupiravir on the $1.2 billion the U.S. government spent to lock up 1.7 million courses of the medicine, which works out to $700 per five day course.

But Anderson points out that the cost for a new pill to treat influenza developed by Roche is just $150 per course. Will the $700 price hold up?

Questions about payment and distribution could play a big role in how big the market for molnupiravir gets.

Anderson assumes in his note to clients that, in the U.S., insurance companies will be paying for the drug through traditional channels. He expects that at $700, insurers will restrict use of the drug to those who are unvaccinated and have multiple risk factors for disease — basically similar profiles to those who are in the trials.

But it’s also possible that sales in the U.S. might be mostly to the government. This is how things have worked with both remdesivir, used in hospitalized patients, and the monoclonal antibodies developed by Regeneron and Eli Lilly. Will the government handle the distribution of a pill granted an emergency use authorization in the same way that it has handled the monoclonals?

若该药进入临床，是否影响疫苗接种和其他疗法应用？

It doesn’t make any sense to forego a Covid vaccine because a pill to treat the disease exists.

The benefits are additive, and someone who got a breakthrough infection and then the pill has a much lower risk of hospitalization than someone who just relied on the pill.

But it seems likely that some people will feel less urgency to get vaccinated as a result of molnupiravir’s existence, and shares in Pfizer, BioNTech, and Moderna all fell on Friday. The latter two are down again Monday morning.

Shares in Regeneron also fell, as oral drugs create uncertainty for its monoclonal antibody treatment for Covid.

The landscape there is uncertain, with other companies coming forward with antibodies that may have advantages.

One small firm, Adagio Therapeutics, recently presented early data on an antibody it thinks could be given as a single shot.

This is simple: it doesn’t. But it’s worth taking a look at what data are available for each.

Ivermectin, ironically, is another Merck drug. The company’s donation of the medicine to be used to combat a parasitic disease called river blindness is one of the great examples of pharmaceutical philanthropy. It’s also used as a veterinary drug to treat heartworm.

Early in the pandemic, there were studies in cell cultures that showed that ivermectin and another drug, hydroxychloroquine, might be worth testing as Covid-19 treatments.

Multiple studies have failed to show a benefit for hydroxychloroquine, but the picture is murkier for ivermectin. Still, one of the largest studies showing a benefit was with drawn due to widespread flaws.

There is a study conducted in Brazil, the Together Trial, that tested a three-day course of ivermectin compared to placebo and showed there was no benefit on hospitalizations and ER visits.

That would make it unlikely that ivermectin, an old antiparasitic, would have efficacy approaching this newer antiviral.

Drug companies are unlikely to conduct large, rigorous studies of older generic medicines — although Novartis did begin, then stop, a hydroxychloroquine study. But right now it is unlikely that ivermectin is the oral Covid medicine the world needs. Molnupiravir, on the other hand, might be.

10月6日(周日)晚8点Zoom在线

主讲：时占祥博士

主动健康干预技术协作平台

讲座内容简介：

疫情期间，全球数字健康和数字医疗蓬勃发展。 凭借惊人增长速度，权威机构预测到2025年将达6600亿美元规模。

2020-2021年期间，投资数字健康和数字医疗领域创下了始料未及的新高。随着医疗健康初创公司和传统医疗机构迈入了数字化新时代，无论政府、企业、风投，甚至传统医疗机构都在变化中，而且，这种变化是不可逆转的。

未来属于数字健康和数字医疗。大批数字医疗初创企业已经继续扩展并证明这一观点和发展趋势。

我们根据2021年度TOP100数字健康百强企业案例，与业界同仁探讨哪些技术、数字化产品、疾病领域和商业模式值得借鉴和参考。

报名微信：GlobalMD2020

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