YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 251 drug applications between 20 August 2021 and 26 August 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 43, covering 32 drug names.
2021/08/20 – 2021/08/26
- New acceptances this week
- 251
- Drugs with new generic filings (by drug name, de-duplicated)
- 32
- Accepted this week, now under review
- 3
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
251filings, 43 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 166 |
| Generic | 43 |
| New drug | 23 |
| Import | 10 |
| Unspecified | 5 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 153 |
| TCM | 60 |
| Therapeutic biologic | 30 |
| Prophylactic biologic | 6 |
| Biologic | 2 |
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
32 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 | Salmeterol Xinafoate and Fluticasone Propionate Powder for Inhalation | 3 | 1 | 12 |
| 3 | Edoxaban Tosilate Tablets | 3 | 1 | 9 |
| 4 | Tedizolid Phosphate For Injection | 2 | 2 | 3 |
| 5 | Voglibose Tablets | 2 | 1 | 0 |
| 6 | Perindopril tert-Butylamine Tablets | 2 | 1 | 5 |
| 7 | Polidocanol Injection | 2 | 1 | 23 |
| 8 | Rivaroxaban Tablets | 1 | 1 | 3 |
| 9 | Ipratropium Bromide Inhalation Solution | 1 | 1 | 2 |
| 10 | Celecoxib Capsules | 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
125 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hubei Ye Zhen Tang Pharma Co., Ltd. romanized | 22 | 22 | 0 |
| 2 | Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized | 16 | 15 | 0 |
| 3 | GUERBET | 13 | 1 | 0 |
| 4 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. | 6 | 3 | 6 |
| 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 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Yuan He Sheng (Jilin) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Health Yuan Pharma Group Co., Ltd. romanized | 4 | 2 | 3 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 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
35 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/08/26Import · Class 1 | M7824 (MSB0011359C) · No verified English nameJXSL2101104 | Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd. |
| 2021/08/26Import · Class 3.3 | 乌司奴单抗注射液 · No verified English nameJXSL2101100 | Alvotech Swiss AG; Alvotech & CCHT Biopharmaceutical Co. Ltd. |
| 2021/08/26Generic · Class 3 | Doxorubicin Hydrochloride Liposome InjectionCYHS2101637 | Zhejiang Zhi Da Pharma Co., Ltd. romanized |
| 2021/08/26New drug · Class 1 | 注射用SKB315 · No verified English nameCXSL2101287 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2021/08/25Import · Class 1 | Rilzabrutinib囊片 · No verified English nameJXHL2101169 | Principia Biopharma Inc.; Sanofi (China) Investment Co. Ltd. |
| 2021/08/25New drug · Class 2.4 | α-双炔失碳酯肠溶片 · No verified English nameCXHL2101430 | Zhejiang Jia Chi Pharmaceuticals Kai Fa Co., Ltd. romanized |
| 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. |
5 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.