Sino US Drug Review And Approval Under The Epidemic Situation: Steady Progress And New Focus

In June 15th, the FDA, the global regulatory agency, issued two announcements: first, the emergency use authorization (EUA) of "chloroquine phosphate and hydroxychloroquine phosphate for the treatment of certain COVID-19 patients in hospital"; and the two approved the first gaming based digital treatment device to improve attention deficit tolerance. The attention function of children with ADHD.

Although the latter is not a drug, the above two measures can almost serve as a representative of FDA in the first half of the year: first, to supervise and approve the treatment of drugs and devices against the spread of the new crown pneumonia epidemic; and the two is to approve more and more diversified drugs and treatments.

According to incomplete statistics of the twenty-first Century economic report, as of June 16th, FDA approved more than 25 new drugs in the first half of 2020. Compared with the 48 new drugs in 2019, the number of approvals affected by the epidemic has not been left behind for the time being.

According to the latest data of the State Administration of drug control, the first batch of reopening and resumption of production in China was released in June 2nd. A number of drug registration certificates were issued in June 2nd, including the raronitin, a rare drug of the baiji Shenzhou tumor drug, Senofi, and second approved indications. Zhengda sunny two approved drugs first approved. According to incomplete statistics of twenty-first Century economic report, as of June 16th, the State Drug Administration (NMPA) approved more than 20 new drugs.

Innovation promotes development. In the past few years, the biopharmaceutical industry has been developing vigorously, which is largely due to the increasingly cooperative and flexible regulatory system of drug regulatory agencies in various countries. Every year, how many new drugs have been released by various gatekeepers to enter the market has become a guide for all pharmaceutical companies and investors to take actions next.

But the 2020 epidemic of new crown pneumonia has changed the concerns of almost all drug developers and related personnel. Among them, regulators are faced with greater pressure and choice: how to approve new drugs efficiently and safely, and take into account the need to fight the epidemic. The attitude of regulators will determine the rhythm and market of drug listing in the second half and future.

One hand "new crown", one hand, "new drugs".

Since January this year, more than 25 new drugs have been approved by FDA. In addition, in response to the outbreak of new crown pneumonia, FDA also approved emergency use authorization including Reed, Wei, chloroquine and hydroxychloroquine.

Judging from the indications of the approved new drugs, these drugs mostly involve anti-tumor, antiviral, rare diseases, cardiovascular diseases, neurological diseases, etc. Tumors include breast cancer, cholangiocarcinoma, lung cancer, thyroid cancer and so on.

In June 12th, FDA approved Tivicay (dolutegravir) and Tivicay PD (dolutegravir) as antiretroviral therapy for HIV children with at least 4 weeks of high and at least 3 kg. In May 29th, FDA approved Oriahnn to treat massive menstrual bleeding associated with uterine leiomyoma in women.

One of the characteristics of FDA's approval in recent years is the emphasis on the approval of drugs for different diseases, especially for rare diseases, and the "drug resistance" of cancer drugs. Of the 59 new drugs approved by FDA in 2018, 34 (58%) were approved for the treatment of rare diseases. In 2019, 21 of the 48 new drugs (44%) were approved for the treatment of rare diseases.

This year's attention to rare drugs remains unchanged, basically keeping the rhythm of at least 2 trials per month. In January 9th, FDA approved the listing of Ayvakit (avapritinib), the first targeted therapy for rare mutations in patients with gastrointestinal stromal tumors. In January 31st, FDA approved the first drug Palforzia to treat peanut allergy in children.

In May 15th, FDA approved Qinlock (ripretinib) as the four line treatment for advanced gastrointestinal stromal tumors (GIST). GIST is a tumor originating from the gastrointestinal tract. The drug obtained the title of "priority review" and "fast track", "breakthrough therapy", "orphan drug" and so on. In May 26th, FDA approved VESIcare LS, the first treatment for bladder dysfunction in children under 2 years of age.

Richard Pazdur, director of the FDA Center for oncology excellence, said: "during the COVID-19 pandemic, everyone's daily life is disturbed. At this critical moment, we hope that patients will know that FDA is still committed to making patients suffering from rare tumors and life-threatening diseases and having unique needs become the top priority. We will continue to accelerate product development for these patients. "

Innovation under the normalization of epidemic prevention and control

Since 2017, the NMPA (former CFDA) has also made a more active attempt to speed up the examination and approval. It has approved more than 40 new drugs every year, which has also contributed to the development of domestic innovative pharmaceutical companies and the innovation and transformation of traditional pharmaceutical companies.

In 2019, the number of approved new drugs in China was also on the shoulders of the United States. In 2019, there were 60 new drugs approved in China, including 4 Chinese herbal medicines and 56 Western medicines. Western medicine contained 43 imported and 13 domestic drugs.

Even at the peak of the epidemic, drug research and development is continuing. There was no delay in the examination and approval in January and February, and the approval channel for drug control was still smooth. The State Administration of Drug Administration approved 164 indications in the first quarter, compared with 141 in the same period last year.

"Due to the cancellation or delay of some related meetings, the epidemic has indeed affected the progress of drug approval and review." One industry insider said to the twenty-first Century economic report, "first, the domestic market was affected, and then the foreign countries were transmitted to the country, with varying degrees of influence. But in general, the impact is not necessarily great, it is two to three months. "

According to the GBI SOURCE database, in January 2020 and February, 7 new drugs (the first Chinese drug listed in the country) were approved, including 4 chemicals and 3 biological products. In March, a total of 4 new drugs were approved, including 3 chemical drugs (hausen pharmaceutical, Silver Valley pharmaceuticals and Shanghai Hui Lun Jiangsu pharmaceutical) and 1 biological products (Wu Tian). In April, a total of 3 new drugs were approved, including 2 chemical drugs and 1 biological products.

Compared to the FDA's attention to rare diseases, most of the new heavy drugs approved in China are cancer drugs, including PD-L1's drug Tecentriq, breast cancer drug emitrozumab, hausen's drug standard ozitinib lung cancer drug amitinib tablets, Baiji Shenzhou lymphoma drug BTK inhibitor zembutini.

In the wake of the gradual resumption of the listing rhythm, the impact of clinical trials during the epidemic period has also affected the subsequent listing rhythm of some drugs.

IQVIA, an internationally renowned consulting firm, points out that in order to cope with the current crisis, the Regulatory Commission and the working group have been switched to telecommuting. The time and effort of the staff is inevitably placed on the approval of COVID-19 treatment drugs and clinical trials related to vaccine development. Therefore, the approval and listing of other products are likely to slow down in the months following the spread of the epidemic.

At the same time, regulators are also facilitating clinical trials of new non crown drugs that are affected by the epidemic. For example, in late March, FDA announced the relaxation of the application of remote monitoring devices for clinical trials to help those who can not or unwilling to go to hospitals to maintain normal clinical trials. FDA will not become an obstacle for pharmaceutical companies to apply for new indications and medicinal value of products. FDA has proposed to enhance the remote / networking of clinical trials as far as possible, including remote visits, telephone interviews and self health management. In the long run, this may become a catalyst to promote the transformation of clinical trials to a distance.