To comprehensively and systematically describe the new molecular entity approvals in the United States, and analyze the trends of new drug development and approval.

Statistical analyses of innovation, expedited programs, and indications were conducted based on information of new molecular entities approved between 1985—2019 in the U. S. Food and Drug Administration (FDA) in the Drugs@FDA database.

There were totally 1 096 new molecular entities approved by FDA between 1985—2019, including 930 chemical and 166 biological products. The proportions of orphan drugs, first-in-class drugs, and drugs approved through priority review in biologics were higher than those in chemical drugs, and the number of biologics approved each year was increasing. The mean drug review time was 594 days, decreasing with year. The review time of biologics, orphan drugs, first-in-class drugs, and drugs approved through priority review was significantly shorter compared to other new molecular entities (P<0.01). The mean review time of antitumor drugs was only 268 days, the shortest among all new drugs within the study period. From 1985 to 2019, the focus of new drug development gradually shifted from the fields of cardiovascular system, digestive system, and infectious diseases to antitumor drugs.

The new drug review time has been shortened, and biologics, orphan drugs, and antitumor drugs has become new focus of drug development.

To establish a rapid, convenient and robust method for detecting the infection titer of Sendai virus (Sev) vectors.

With transmission-defective Sendai virus vector as the research target and flow cytometry as the detection method, a mathematic model based on Poisson's distribution was established, and the infection titer was determined by one parameter of the mathematic model after curve-fitting.

An innovative method for detecting the infection titer of Sendai virus vector was successfully established. There were no significant differences between the results obtained from the flow cytometry method and traditional immunofluorescence method, and the flow cytometry method displayed good reproducibility [infection titer is (2.13±0.05)×10⁹ IU·mL^-1, RSD is 2.34%].

The infection titer detection is an important quality control item of viral vector gene therapy products and the traditional methods such as plaque method, TCID₅₀ method and immunofluorescence method have the disadvantages of long experiment cycle, bad reproducibility and poor objectivity. This study is of significance to be a representative quality control reference for infection titer detecting of other viral vectors.

To observe the efficacy and safety of clindamycin hydrochloride palmitate dispersion tablets for the treatment of chronic periodontitis.

One hundred and fifty patients diagnosed with chronic periodontitis in our hospital from May 2020 to May 2021 were randomly divided into observation group (75 cases) and control group (75 cases). After the initial therapy of periodontal diseases, the two groups were administered with clindamycin hydrochloride palmitate dispersion tablets or cefaclor sustained-release capsules combined with metronidazole tablets for one week, respectively. Periodontal indexes, such as bleeding on probing (BOP), bleeding index (BI), periodontal probe depth (PD) and adhesion level (AL), as well as the total effective rate, incidence of adverse events and patient compliance, were observed and compared between the two groups.

Compared with the control group, the incidences of BOP and BI were significantly lower in the observation group after treatment (P<0.01), but PD and AL had no significant difference (P>0.05). The total effective rate of treatment in the observation group was lower than that of the control group, but the difference was not statistically significant (P>0.05). The incidence of adverse events in the observation group was lower than the control group and the patients had good compliance.

Clindamycin hydrochloride palmitate dispersion tablets was effective in the treatment of chronic periodontitis, with low incidence of adverse events, good safety and patient compliance.

To compare the lipid-regulating effects of long gypenosides and gypenosides.

Ninety male rats were randomly divided into control group, model group, positive group (1 mg·kg^-1), gypenosides groups (60, 30 and 15 mg·kg^-1) and long gypenosides groups (60, 30 and 15 mg·kg^-1). The hyperlipidemia model was established by feeding high-fat diets, then all rats were intervened with corresponding medicines for 6 weeks. The body weight, liver index, levels of blood lipid, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were determined. HE staining was conducted to evaluate the histopathological changes of livers.

Compared with the control group, the body weight, liver index, total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), ALT and AST in the model group were significantly increased. The high-density lipoprotein cholesterol (HDL-C) level was significantly decreased. Fatty degeneration was obviously observed in liver tissue. Compared with the model group, gypenosides significantly decreased TC and ALT levels in serum. Long gypenosides significantly reduced the levels of TC, TG, AST and ALT, increased the level of HDL-C. High dose long gypenosides and gypenosides relieved the fatty degeneration. The results of correlation analysis showed that the levels of TC, TG and AST in serum correlated with plant origin.

Long gypenosides and gypenosides can reduce blood lipid and have positive effect on liver tissue of hyperlipidemia rats, especially long gypenosides.

To comprehensively evaluate the quality of Centella asiatica by combining the sensory characteristics and gray relational analysis to improve the reliability and scientificity of the quality evaluation of Centella asiatica.

The characteristics, microscopic structure and thin layer chromatography of Centella asiatica were identified by pharmacognosy methods; the impurity, moisture, total ash and extract content were determined with reference to the fourth general rule of the Chinese Pharmacopoeia; HPLC method was used to determine the contents of impurities, moisture, total ash and extracts of Centella asiatica. The contents of asiaticoside and madecassoside were determined; the gray relational analysis was used to construct the quality evaluation model of Centella asiatica, and the relative degree of correlation was calculated.

There were no significant differences in the characteristics and microscopic structure of Centella asiatica from different producing areas; thin layer chromatography could detect both asiaticoside and madecassoside; the impurity content was 0.500%~8.837%; the moisture content was 4.899%~6.423%; the total ash content was 10.103%~16.368%; the extract content was 28.100%~38.311%; the asiaticoside content was 0.383%~1.019%; the madecassoside content was 0.541%~1.915%. Combined with various factors such as impurities, moisture, total ash, extract, asiaticoside and madecassoside, it was indicated that the 29 batches of Centella asiatica from different producing areas had quality differences and their relative correlations degree values were in the range of 0.437~0.556. The top 3 samples are S15, S8, and S9, Centella asiatica produced in Xiajiang county, Ji'an city, Jiangxi province, the measured relative degree of correlation is larger, and the quality ranking is higher, indicating that the quality of Centella asiatica produced in Xiajiang county, Ji'an city, Jiangxi province is better.

The quality evaluation model established by the sensory characteristics combined with gray relational analysis can be used for the quality evaluation of Centella asiatica from different producing areas.

To evaluate the purification process of Weixuening mixture extract by alcohol precipitation method and membrane separation method.

In this study, the Weixuening mixture extract was used as the research object, and physicochemical parameters, solid removal rate, and the transfer rates of indicative components were used as the indexes to evaluate the two different refining processes of Weixuening mixture extract, i.e., alcohol precipitation method and membrane separation method. By investigating the influences of different molecular weight cut-offs, operating pressure, and extracting solution concentration on membrane separation index and membrane flux, the best purification process was selected.

The physicochemical parameters of the membrane separation method were significantly better than those of the alcohol precipitation method. The transfer rates of the indicative components of the alcohol precipitation solution such as catechin, epicatechin, polydatin, resveratrol, and quercetin, respectively, were 82.34%, 83.31%, 79.06%, 77.51%, and 80.16%, respectively. The solid removal rate was 64.75%. The best process for membrane separation was as follows: the membrane pressure was 0.5 MPa; the extract concentration was 0.11 g·mL^-1; the molecular weight cutoff was 30 kDa. The transfer rates of the indicative components such as catechin, epicatechin, polydatin, resveratrol, and quercetin in the membrane separated solution were 83.44%, 84.32%, 80.42%, 83.36%, and 83.58%, respectively. The membrane flux was 10.57 mL·m^-2·min^-1 and the solid removal rate was 65.96%.

Compared with the alcohol precipitation method, the membrane separation method is more conducive to the refining of the extract of Weixuening mixture, which lays the foundation for the industrial production of Weixuening mixture.

To explore the internal factors affecting the quality of cefotiam hydrochloride for injection.

The routine quality items of cefotiam hydrochloride for injection products from different manufactures were evaluated, and the thermal stability was compared. The degradation impurities were analyzed using column switching LC-MS, the crystal forms of products with different manufactures were compared by powder X diffraction method, the particle size distribution of the products was determined by light scattering method, and TGA and near infrared spectroscopy were used to predict the binding mode of water.

The differences of the routine quality among the products from different manufacturers were small, but the thermal stability and internal quality showed significant differences.

The main internal factors affecting the thermal stability of cefotiam hydrochloride for injection were crystal size distribution and sodium carbonate content. The evaluation of product quality should start with its internal quality, so as to evaluate the advantages and disadvantages of the production process.

To establish the 10^th national standard for human chorionic gonadotrophin (HCG).

According to Chinese Pharmacopoeia (Volume Ⅳ, 2015 edition) 1209 Chorionic Gonadotrophin bioassay, the 5^th batch of international standard 07/364 was taken as reference, six laboratories collaboratively calibrated the biotiter of the 10^th HCG nation standard.

The 10^th batch of HCG national standard products was determined to have biological titer of 55 IU·per ampoule after collaborative calibration.

The candidate was established as the 10^th national standard for the determination of the titer of HCG API and preparations.

To analyze the information of clinical trial subjects who stopped taking drugs during the epidemic period, so as to provide guidance for the follow-up of clinical trial subjects under special events.

The data of subjects in clinical trials of melanoma who stopped treatment during the epidemic period from February 3, 2020 to May 29, 2020 were collected. SPSS 24.0 statistical analysis software was used to compare the general data and clinical trial information between patients with advanced disease and patients without disease progression.

A total of 32 subjects were included, including 15 progressive subjects and 17 non progressing subjects. Gender, primary site, enrollment test, previous treatment, recurrence and metastasis site, best evaluation during enrollment, and administration regimen were independent risk factors for disease-free progression (P<0.05). There was significant difference in the number of medication cycles between the two groups.

The previous best efficacy, medication regimen, and number of medication cycles have significant effects on the outcome of cancer clinical trials under special public health events.

To explore the clinical and pathological characteristics, treatment measures and clinical outcome of programmed death 1/programmed death ligand 1 (PD-1/PD-L1) inhibitors-induced skin vasculitis.

Relevant domestic and foreign databases (up to November 30, 2020) were searched, case reports and clinical research papers on skin vasculitis caused by PD-1/PD-L1 inhibitors were collected, and the characteristics of PD-1/PD-L1 inhibitor-induced skin vasculitis was analyzed using descriptive statistics.

A total of 11 patients were included in the analysis. Patient medications included four cases of nivolumab, three cases of pembrolizumab, one case of duvaluzumab, one case of nivolumab combined with ipilimumab, and one case of pembrolizumab combined with ipilimumab. One patient did not provide the name of the drug. The time from the patients' start of using PD-1/PD-L1 inhibitor to the appearance of skin vasculitis was 1 to 28 weeks, with a median time of 8 weeks (3~13). The skin vasculitis manifested as skin purpura or skin necrosis, which may be accompanied by immune related adverse events of other systems, and skin biopsy showed perivascular neutrophil and lymphocyte infiltration with focal fibrinoid necrosis. Glucocorticoid therapy was the main treatment measure, and the prognosis was good. Most patients got remission. The recover time ranged from 2 to 60 days, with a median time of 30 (13~50) days.

Vasculitis is a rare adverse reaction of PD-1/PD-L1 inhibitors. Skin purpura is the main manifestation. Glucocorticoids can be used for treatment. The prognosis is good, but it may be combined with other serious adverse reactions, which should be paid attention to in clinical practice.