YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 202 drug applications between 6 June 2021 and 12 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 27 drug names.
2021/06/06 – 2021/06/12
- New acceptances this week
- 202
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- Accepted this week, now under review
- 0
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
202filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 100 |
| Generic | 40 |
| New drug | 39 |
| Import re-registration | 11 |
| Import | 10 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 147 |
| Therapeutic biologic | 27 |
| TCM | 22 |
| Prophylactic biologic | 6 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oxcarbazepine Tablets | 3 | 1 | 4 |
| 2 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 3 | Ornidazole Injection | 2 | 1 | 0 |
| 4 | Obeticholic Acid Tablets | 2 | 1 | 0 |
| 5 | Levofloxacin Tablets | 2 | 1 | 7 |
| 6 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 7 | 注射用头孢美唑钠/氯化钠注射液 · No verified English name | 2 | 1 | 1 |
| 8 | Daptomycin for Injection | 2 | 1 | 1 |
| 9 | Epinastine Hydrochloride Granules | 2 | 1 | 0 |
| 10 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English name | 2 | 1 | 2 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
112 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 2 | Tong Yong Dian Qi Pharma (Shanghai) Co., Ltd. romanized | 7 | 1 | 0 |
| 3 | AstraZeneca AB | 6 | 3 | 0 |
| 4 | Bristol-Myers Squibb Pharma EEIG | 5 | 1 | 0 |
| 5 | Guo Yao Group Rong Sheng Pharmaceutical Co., Ltd. romanized | 4 | 3 | 0 |
| 6 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized | 4 | 3 | 0 |
| 7 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 3 |
| 8 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Beijing Bao Nian Tang (He Ze) Pharma Co., Ltd. romanized | 3 | 3 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
57 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/11Generic · Class 3 | Epinastine Hydrochloride GranulesCYHS2101293 | Jiao Zuo Shi Ming Ren Tian Ran Drug Co., Ltd. romanized |
| 2021/06/11Generic · Class 3 | Epinastine Hydrochloride GranulesCYHS2101292 | Jiao Zuo Shi Ming Ren Tian Ran Drug Co., Ltd. romanized |
| 2021/06/11Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2101291 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/06/11Generic · Class 3 | 注射用头孢美唑钠/氯化钠注射液 · No verified English nameCYHS2101251 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized |
| 2021/06/11Generic · Class 3 | 注射用头孢美唑钠/氯化钠注射液 · No verified English nameCYHS2101250 | Beijing Rui Ye Pharmaceutical Co., Ltd. romanized |
| 2021/06/11New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2101131 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/06/11New drug · Class 3.4 | 卡介菌纯蛋白衍生物 · No verified English nameCXSL2101114 | Chengdu Ke En Bio Technology Co., Ltd. romanized |
| 2021/06/11New drug · Class 1 | 盐酸安舒法辛缓释片 · No verified English nameCXHS2101024 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/06/11New drug · Class 1 | 盐酸安舒法辛缓释片 · No verified English nameCXHS2101023 | Shandong Lv Ye Pharmaceutical Co., Ltd. romanized |
| 2021/06/11New drug · Class 1 | VC005片 · No verified English nameCXHL2101199 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/11New drug · Class 1 | VC005片 · No verified English nameCXHL2101198 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/11New drug · Class 1 | VC005片 · No verified English nameCXHL2101197 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/11New drug · Class 1 | VC005片 · No verified English nameCXHL2101196 | Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | 注射用IMM01 · No verified English nameCXSL2101130 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2101122 | Qilu Pharmaceutical Co., Ltd. |
| 2021/06/10New drug · Class 1.4 | 24价肺炎球菌多糖结合疫苗 · No verified English nameCXSL2101113 | Jiangsu Kun Li Biopharmaceutical Co., Ltd. romanized; Shandong Kun Li Biopharmaceutical Co., Ltd. romanized |
| 2021/06/10New drug · Class 2.2 | 小儿水合氯醛糖浆 · No verified English nameCXHL2101193 | Hainan Peng Kang Pharma Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | HEC93077片 · No verified English nameCXHL2101192 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | HEC93077片 · No verified English nameCXHL2101191 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | HEC93077片 · No verified English nameCXHL2101190 | Guangdong Dong Yang Guang Pharma Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | HRS2300片 · No verified English nameCXHL2101189 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | HRS2300片 · No verified English nameCXHL2101188 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | LNK01001胶囊 · No verified English nameCXHL2101186 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2021/06/10New drug · Class 1 | LNK01001胶囊 · No verified English nameCXHL2101185 | Ling Ke Pharma (Hangzhou) Co., Ltd. romanized |
| 2021/06/09Import · Class 1 | BI 425809 片 · No verified English nameJXHL2101086 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/06/09Generic · Class 3 | Obeticholic Acid TabletsCYHL2101014 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/06/09Generic · Class 3 | Obeticholic Acid TabletsCYHL2101013 | Yangtze River Pharmaceutical Group Co., Ltd |
| 2021/06/09New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101128 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/09New drug · Class 1 | IBI110 · No verified English nameCXSL2101127 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/06/09New drug · Class 2.2 | HRG2010胶囊 · No verified English nameCXHL2101178 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
27 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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