YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 237 drug applications between 27 November 2021 and 3 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 34 drug names.
2021/11/27 – 2021/12/03
- New acceptances this week
- 237
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- Accepted this week, now under review
- 1
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
237filings, 48 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 125 |
| Generic | 48 |
| New drug | 31 |
| Import | 17 |
| Unspecified | 9 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 152 |
| TCM | 55 |
| Therapeutic biologic | 27 |
| 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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Esomeprazole Magnesium for Delayed-release Oral Suspension | 3 | 2 | 4 |
| 2 | Rabeprazole Sodium Enteric-coated Tablets | 3 | 2 | 0 |
| 3 | Lactulose Oral Solution | 3 | 1 | 34 |
| 4 | Citicoline Sodium Injection | 3 | 1 | 3 |
| 5 | Perindopril tert-Butylamine Tablets | 2 | 1 | 5 |
| 6 | Pregabalin Capsules | 2 | 1 | 12 |
| 7 | Cefminox Sodium for Injection | 2 | 1 | 0 |
| 8 | Parecoxib Sodium for Injection | 2 | 1 | 2 |
| 9 | Palonosetron Hydrochloride Injection | 2 | 1 | 1 |
| 10 | Sitagliptin Phosphate Tablets | 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
130 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Wuhan Ai Min Pharmaceutical Co., Ltd. romanized | 21 | 17 | 0 |
| 2 | Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized | 14 | 13 | 0 |
| 3 | Shijiazhuang Yu He Tang Pharma Co., Ltd. romanized | 8 | 8 | 0 |
| 4 | Hua Run Shuang He Pharma Co., Ltd. romanized | 7 | 4 | 0 |
| 5 | Novartis Pharma AG | 5 | 3 | 0 |
| 6 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Jiangsu En Hua Pharma Co., Ltd. romanized | 5 | 3 | 0 |
| 8 | Roche Pharma (Schweiz) AG | 4 | 1 | 0 |
| 9 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 3 | 3 | 2 |
| 10 | Lilly France | 3 | 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
60 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/03Import · Class 1 | OMS721注射液 · No verified English nameJXSL2101144 | Omeros Corporation; George (Beijing) Clinical Research Co. Ltd. |
| 2021/12/03Generic · Class 3 | Milnacipran Hydrochloride TabletsCYHS2102131 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | JS009注射液 · No verified English nameCXSL2101462 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | MSB0254注射液 · No verified English nameCXSL2101449 | Mai Bo Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | MSB2311注射液 · No verified English nameCXSL2101448 | Mai Bo Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | ASKC202片 · No verified English nameCXHL2101712 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | ASKC202片 · No verified English nameCXHL2101711 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | HY010101胶囊 · No verified English nameCXHL2101709 | Beijing Yuan Ji Hua Yi Bio Technology Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | HY010101胶囊 · No verified English nameCXHL2101708 | Beijing Yuan Ji Hua Yi Bio Technology Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | HY010101胶囊 · No verified English nameCXHL2101707 | Beijing Yuan Ji Hua Yi Bio Technology Co., Ltd. romanized |
| 2021/12/03New drug · Class 1 | TLL-018片 · No verified English nameCXHL2101706 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized |
| 2021/12/02Import · Class 2.2 | 注射用维博妥珠单抗(拟定) · No verified English nameJXSS2101035 | Roche Pharma (Schweiz)AG; F. Hoffmann-La Roche AG |
| 2021/12/02Import · Class 2.2 | 注射用维博妥珠单抗(拟定) · No verified English nameJXSS2101034 | Roche Pharma (Schweiz)AG; BSP Pharmaceuticals S.p.A. |
| 2021/12/02Import · Class 3.3 | 特立帕肽注射液 · No verified English nameJXSL2101143 | Alvogen Inc.; Beijing Kangchen Biological Technology Co. Ltd. |
| 2021/12/02Import · Class 1 | QGE031注射液 · No verified English nameJXSL2101141 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2021/12/02Generic · Class 3 | Carbocisteine Oral SolutionCYHS2102126 | Chengdu Bei Te De Nuo Pharma Co., Ltd. romanized |
| 2021/12/02Generic · Class 3 | Flurbiprofen Axetil InjectionCYHL2101046 | Shandong Wei Gao Pharma Co., Ltd. romanized |
| 2021/12/02Generic · Class 3 | Daunorubicin and Cytarabine liposome For InjectionCYHL2101045 | CSPC ZHONGNUO PHARMACEUTICAL (SHIJIAZHUANG) CO., LTD. |
| 2021/12/02Generic · Class 3 | Minodronic acid TabletsCYHL2101044 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2021/12/02Generic · Class 3 | Esketamine Hydrochloride InjectionCYHL2101043 | Guo Yao Group Guo Rui Pharma Co., Ltd. romanized |
| 2021/12/02New drug · Class 2.2 | 小儿盐酸小檗碱无水吞服颗粒 · No verified English nameCXHL2101705 | Kunming Bang Yu Pharmaceutical Co., Ltd. romanized |
| 2021/12/02New drug · Class 2.2 | 小儿盐酸小檗碱无水吞服颗粒 · No verified English nameCXHL2101704 | Kunming Bang Yu Pharmaceutical Co., Ltd. romanized |
| 2021/12/02New drug · Class 1 | IMP4297胶囊 · No verified English nameCXHL2101703 | Shanghai Jun Pai Ying Shi Pharma Co., Ltd. romanized |
| 2021/12/01Import · Class 1 | 注射用Zolbetuximab · No verified English nameJXSL2101142 | Astellas Pharma Global Development Inc.; Astellas Pharma China Inc. |
| 2021/12/01Import · Class 1 | LOU064片 · No verified English nameJXHL2101264 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co.,Ltd. |
| 2021/12/01Import · Class 1 | LOU064片 · No verified English nameJXHL2101263 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co.,Ltd. |
| 2021/12/01Generic · Class 3 | Esomeprazole Magnesium for Delayed-release Oral SuspensionCYHS2102122 | Jiangsu Ao Sai Kang Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2021/12/01Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2102117 | Beijing Ming Ze Zhong He Drug Research Co., Ltd. romanized; Tong Fang Pharma Group Co., Ltd. romanized |
| 2021/12/01Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2102111 | Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized; Tianjin Han Rui Pharma Co., Ltd. romanized |
| 2021/12/01New drug · Class 1 | 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2101458 | Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized |
30 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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