YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 224 drug applications between 15 August 2021 and 21 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 33 drug names.
2021/08/15 – 2021/08/21
- New acceptances this week
- 224
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- 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
224filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 116 |
| Generic | 45 |
| New drug | 29 |
| Unspecified | 15 |
| Import | 14 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 148 |
| TCM | 38 |
| Therapeutic biologic | 35 |
| Biologic | 3 |
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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ornidazole Injection | 4 | 2 | 0 |
| 2 | Perampanel Tablets | 4 | 1 | 2 |
| 3 | Rivaroxaban Tablets | 3 | 2 | 3 |
| 4 | Voglibose Tablets | 2 | 1 | 0 |
| 5 | Trelagliptin Succinate Tablets | 2 | 1 | 1 |
| 6 | Iopamidol Injection | 2 | 1 | 0 |
| 7 | Sugammadex Sodium Injection | 2 | 1 | 6 |
| 8 | Tadalafil Tablets | 1 | 1 | 23 |
| 9 | Ambroxol Hydrochloride Solution For Inhalation | 1 | 1 | 10 |
| 10 | Doxofylline Injection | 1 | 1 | 5 |
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
133 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Run Zhong Pharma Co., Ltd. romanized | 16 | 15 | 0 |
| 2 | Jilin Hua Kang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Shaanxi Bao Ling Kang Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 4 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 5 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Shandong Er Ye Pharmaceutical Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized | 4 | 2 | 1 |
| 8 | Merck Sharp & Dohme Corp. | 4 | 1 | 0 |
| 9 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized | 4 | 1 | 4 |
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
55 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/20Generic · Class 3 | Calcium Gluconate InjectionCYHS2101610 | Zhejiang Rui Bang Pharma Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/08/20Generic · Class 3 | Trelagliptin Succinate TabletsCYHS2101572 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/08/20New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSS2101021 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized; Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2021/08/20New drug · Class 1 | TQB2450注射液 · No verified English nameCXSL2101276 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/08/20New drug · Class 2.2 | 丁苯酞注射液 · No verified English nameCXHL2101422 | Ao Xin Yang Guang (Beijing) Pharma Technology Co., Ltd. romanized |
| 2021/08/20New drug · Class 1 | BEBT-209胶囊 · No verified English nameCXHL2101421 | Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/20New drug · Class 1 | BEBT-209胶囊 · No verified English nameCXHL2101420 | Guangzhou Bi Bei Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/19Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2101099 | MedImmune LLC; AstraZeneca Investment (China) Co. Limited |
| 2021/08/19Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2101604 | Haikou Tian Xing Jian Drug Research Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | AK112注射液 · No verified English nameCXSL2101274 | Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | YH003注射液 · No verified English nameCXSL2101273 | Name not romanized |
| 2021/08/19New drug · Class 2.2 | 克来夫定胶囊 · No verified English nameCXHL2101419 | Guangxi Hui Bao Yuan Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/19New drug · Class 2.2 | 克来夫定胶囊 · No verified English nameCXHL2101418 | Guangxi Hui Bao Yuan Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | ENN0403 胶囊 · No verified English nameCXHL2101417 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | ENN0403 胶囊 · No verified English nameCXHL2101416 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | ENN0403 胶囊 · No verified English nameCXHL2101415 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | JAB-21822片 · No verified English nameCXHL2101414 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | JAB-21822片 · No verified English nameCXHL2101413 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | JAB-21822片 · No verified English nameCXHL2101406 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/08/19New drug · Class 1 | JAB-21822片 · No verified English nameCXHL2101405 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2021/08/18Import · Class 1 | LNP023胶囊 · No verified English nameJXHL2101167 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/08/18Generic · Class 3 | Tofacitinib Citrate Extended Release tabletsCYHS2101602 | Sichuan Ke Lun Drug Research Institute Co., Ltd. romanized; Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2021/08/18New drug · Class 1 | QX005N注射液 · No verified English nameCXSL2101272 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/18New drug · Class 2.2 | 丁苯酞注射液 · No verified English nameCXHL2101404 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized |
| 2021/08/18New drug · Class 1 | ICP-189片 · No verified English nameCXHL2101337 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/17Import · Class 1 | Relatlimab/Nivolumab固定剂量复方注射液 · No verified English nameJXSL2101097 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2021/08/17Import · Class 1 | JNJ-63733657注射液 · No verified English nameJXSL2101091 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2021/08/17Import · Class 1 | 注射用普那布林浓溶液 · No verified English nameJXHS2101041 | BeyondSpring Pharmaceuticals Inc.; Pharmaceutics International Incorporated(Pii); Dalian Wanchun Bulin Pharmaceutical Co. Ltd. |
| 2021/08/17Import · Class 1 | Difelikefalin注射液 · No verified English nameJXHL2101166 | Vifor Fresenius Medical Care Renal Pharma Ltd.; Hangzhou Tigermed Consulting Co. Ltd. |
| 2021/08/17Generic · Class 3 | Paracetamol and Caffeine TabletsCYHS2101600 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
25 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.