YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 116 drug applications between 5 October 2021 and 11 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 16 drug names.
2021/10/05 – 2021/10/11
- New acceptances this week
- 116
- Drugs with new generic filings (by drug name, de-duplicated)
- 16
- 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
116filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 65 |
| Generic | 20 |
| New drug | 16 |
| Unspecified | 8 |
| Import | 6 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 76 |
| Therapeutic biologic | 22 |
| TCM | 14 |
| Biologic | 4 |
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
16 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Parecoxib Sodium for Injection | 3 | 2 | 2 |
| 2 | Ornidazole Injection | 2 | 1 | 0 |
| 3 | Cyclophosphamide Capsules | 2 | 1 | 2 |
| 4 | Lidocaine Cataplasms | 1 | 1 | 7 |
| 5 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 6 | Diquafosol Sodium Eye Drops | 1 | 1 | 5 |
| 7 | Olmesartan Medoxomil Tablets | 1 | 1 | 1 |
| 8 | Sildenafil Citrate Tablets | 1 | 1 | 12 |
| 9 | 氧 · No verified English name | 1 | 1 | 15 |
| 10 | Amlodipine Besylate and Atorvastatin Calcium Tablets | 1 | 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
80 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hainan Zhuo Ke Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 2 | Hangzhou Minsheng Pharmaceutical Co., Ltd | 3 | 3 | 0 |
| 3 | Jiangxi Di Kang Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 4 | Janssen-Cilag International NV | 3 | 2 | 0 |
| 5 | Cheng De Xin Ai Min Pharmaceutical Co., Ltd. romanized | 3 | 2 | 0 |
| 6 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized | 3 | 1 | 0 |
| 7 | Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 8 | Zhejiang Guo Jing Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 9 | Zhejiang Dou Bang Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 10 | Shenzhen Li Jian Pharma Co., Ltd. romanized | 3 | 1 | 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
28 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/11Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2101830 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2021/10/11Generic · Class 3 | Ornidazole InjectionCYHS2101828 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/10/11Generic · Class 3 | Ornidazole InjectionCYHS2101827 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2021/10/11Generic · Class 3 | Lidocaine CataplasmsCYHS2101824 | Hainan Hui Yuan Tang Pharma Co., Ltd. romanized |
| 2021/10/11New drug · Class 1 | QLF31911注射液 · No verified English nameCXSL2101354 | Qilu Pharmaceutical Co., Ltd. |
| 2021/10/11New drug · Class 1 | 人源TH-SC01细胞注射液 · No verified English nameCXSL2101353 | Jiangsu Tuo Hong Kang Heng Pharmaceuticals Co., Ltd. romanized |
| 2021/10/11New drug · Class 1 | ZX-101A胶囊 · No verified English nameCXHL2101543 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2021/10/11New drug · Class 1 | ZX-101A胶囊 · No verified English nameCXHL2101542 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2021/10/11New drug · Class 1 | ZX-101A胶囊 · No verified English nameCXHL2101541 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized |
| 2021/10/11New drug · Class 1 | AN4005片 · No verified English nameCXHL2101540 | Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/11New drug · Class 1 | AN4005片 · No verified English nameCXHL2101539 | Hangzhou A Nuo Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/10/11New drug · Class 2.2 | 复方对乙酰氨基酚缓释片 · No verified English nameCXHL2101530 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2021/10/09Import · Class 1 | Troriluzole 胶囊 · No verified English nameJXHL2101196 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/10/09Import · Class 1 | Troriluzole 胶囊 · No verified English nameJXHL2101195 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/10/09Import · Class 1 | 注射用 WCK5222 · No verified English nameJXHL2101191 | Wockhardt Bio AG; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2021/10/09Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2101826 | Wu Hu Yang Yan Pharmaceutical Co., Ltd. romanized |
| 2021/10/09New drug · Class 1.1 | 九味疏风平喘颗粒 · No verified English nameCXZL2101028 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2021/10/09New drug · Class 1 | LBL-019注射液 · No verified English nameCXSL2101348 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2021/10/09New drug · Class 1 | TST005注射液 · No verified English nameCXSL2101346 | Mai Bo Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/10/09New drug · Class 1 | SHR-1314注射液 · No verified English nameCXSL2101345 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/10/08Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSL2101116 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/10/08Import · Class 1 | BI-1206 · No verified English nameJXSL2101115 | BioInvent International AB; CASI Pharmaceuticals (China) Co. Ltd. |
| 2021/10/08Generic · Class 3 | Cyclophosphamide CapsulesCYHS2101811 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/10/08Generic · Class 3 | Cyclophosphamide CapsulesCYHS2101810 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/10/08New drug · Class 1 | LY01019注射液 · No verified English nameCXSL2101351 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2021/10/08New drug · Class 1 | SIM1811-03注射液 · No verified English nameCXSL2101350 | Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized |
| 2021/10/08New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101347 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2021/10/08New drug · Class 2.2 | 醋酸阿比特龙软胶囊 · No verified English nameCXHL2101528 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized |
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.