YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 246 drug applications between 18 August 2021 and 24 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 28 drug names.
2021/08/18 – 2021/08/24
- New acceptances this week
- 246
- Drugs with new generic filings (by drug name, de-duplicated)
- 28
- 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
246filings, 34 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 148 |
| New drug | 35 |
| Generic | 34 |
| Unspecified | 15 |
| Import | 10 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 163 |
| TCM | 48 |
| Therapeutic biologic | 28 |
| Biologic | 4 |
| Prophylactic 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
28 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Perampanel Tablets | 4 | 1 | 2 |
| 2 | 硫酸特布他林雾化吸入用溶液 · No verified English name | 2 | 2 | 1 |
| 3 | Voglibose Tablets | 2 | 1 | 0 |
| 4 | Perindopril tert-Butylamine Tablets | 2 | 1 | 5 |
| 5 | Rivaroxaban Tablets | 1 | 1 | 3 |
| 6 | Ipratropium Bromide Inhalation Solution | 1 | 1 | 2 |
| 7 | Ambroxol Hydrochloride Solution For Inhalation | 1 | 1 | 10 |
| 8 | Celecoxib Capsules | 1 | 1 | 5 |
| 9 | Doxofylline Injection | 1 | 1 | 5 |
| 10 | Levofloxacin Tablets | 1 | 1 | 7 |
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
131 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 | GUERBET | 13 | 1 | 0 |
| 3 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Hubei Mei Si Chuang Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Qin Huang Dao Da En Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Shaanxi Bao Ling Kang Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 7 | Merck Sharp & Dohme Corp. | 5 | 1 | 0 |
| 8 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Hainan Si Da Pharmaceutical Co., Ltd. romanized | 4 | 4 | 2 |
| 10 | Yuan He Sheng (Jilin) Pharma Co., Ltd. romanized | 4 | 4 | 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
47 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/24Import · Class 1 | DS-1062a · No verified English nameJXSL2101101 | Daiichi Sankyo Inc.; AstraZeneca Investment (China) Co. Limited |
| 2021/08/24Generic · Class 3 | Dexmedetomidine Hydrochloride InjectionCYHS2101630 | Beijing Fei Sen You Si Ka Bi Pharmaceuticals Co., Ltd. romanized; Nanjing Jian You Sheng Hua Pharmaceutical Co., Ltd. romanized |
| 2021/08/24New drug · Class 1 | IM21嵌合抗原受体T细胞注射液(IM21 CAR-T细胞注射液) · No verified English nameCXSL2101281 | Beijing Yi Miao Shen Zhou Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/24New drug · Class 1 | 重组抗金黄色葡萄球菌毒素人源化单克隆抗体注射液 · No verified English nameCXSL2101277 | Xing Meng Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/08/24New drug · Class 2.2 | 复方葡萄糖酸钙颗粒 · No verified English nameCXHS2101035 | Xinjiang Te Feng Pharma Co., Ltd. romanized |
| 2021/08/24New drug · Class 2.4 | 妥布霉素雾化吸入溶液 · No verified English nameCXHL2101429 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2021/08/24New drug · Class 2.4 | Irinotecan Liposome injectionCXHL2101428 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/08/24New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2101412 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/08/24New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2101411 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/08/24New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2101410 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/08/23Import · Class 3.1 | 雷莫西尤单抗注射液 · No verified English nameJXSS2101018 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2021/08/23Import · Class 3.1 | 雷莫西尤单抗注射液 · No verified English nameJXSS2101017 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2021/08/23Import · Class 1 | BI655130注射液 · No verified English nameJXSL2101098 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2021/08/23Import · Class 2.4 | ATG-010片 · No verified English nameJXHL2101168 | Karyopharm Therapeutics Inc.; Antengene Corporation Co. Ltd. |
| 2021/08/23New drug · Class 3.2 | 口服五价重配轮状病毒减毒活疫苗(Vero细胞) · No verified English nameCXSL2101279 | Shenzhen Kang Tai Bio Zhi Pin Co., Ltd. romanized; Beijing Min Hai Bio Technology Co., Ltd. romanized |
| 2021/08/23New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2101275 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/23New drug · Class 1 | 重组抗PD-1人源化单克隆抗体注射液 · No verified English nameCXSL2101270 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/08/23New drug · Class 1 | ATG-008片 · No verified English nameCXHL2101427 | Shanghai De Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/23New drug · Class 1 | ATG-008片 · No verified English nameCXHL2101426 | Shanghai De Qi Pharmaceuticals Technology Co., Ltd. romanized |
| 2021/08/23New drug · Class 2.4 | Apatinib Mesylate TabletsCXHL2101425 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/23New drug · Class 2.4 | Apatinib Mesylate TabletsCXHL2101424 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/08/23New drug · Class 2.4 | Apatinib Mesylate TabletsCXHL2101423 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 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 |
17 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.