YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 231 drug applications between 1 December 2021 and 7 December 2021 (data as of 14 November 2026 06:00). Of these, generic applications numbered 55, covering 45 drug names.
2021/12/01 – 2021/12/07
- New acceptances this week
- 231
- Drugs with new generic filings (by drug name, de-duplicated)
- 45
- 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
231filings, 55 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 116 |
| Generic | 55 |
| New drug | 26 |
| Import | 13 |
| Unspecified | 11 |
| Import re-registration | 10 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 157 |
| TCM | 43 |
| Therapeutic biologic | 28 |
| 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
45 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Rabeprazole Sodium Enteric-coated Tablets | 3 | 2 | 0 |
| 2 | Lactulose Oral Solution | 3 | 1 | 34 |
| 3 | Pregabalin Capsules | 2 | 1 | 12 |
| 4 | Rifampin For Injection | 2 | 1 | 2 |
| 5 | Cefminox Sodium for Injection | 2 | 1 | 0 |
| 6 | Palonosetron Hydrochloride Injection | 2 | 1 | 1 |
| 7 | Guanfacine Hydrochloride Extended Release Tablets | 2 | 1 | 4 |
| 8 | Sitagliptin Phosphate Tablets | 2 | 1 | 2 |
| 9 | Acetylcysteine Effervescent Tablets | 1 | 1 | 3 |
| 10 | Tadalafil Tablets | 1 | 1 | 23 |
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
145 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | Hua Run Shuang He Pharma Co., Ltd. romanized | 10 | 7 | 0 |
| 3 | Wuhan Ai Min Pharmaceutical Co., Ltd. romanized | 6 | 6 | 0 |
| 4 | Novartis Pharma AG | 6 | 3 | 0 |
| 5 | Shaanxi Chang Ming Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized | 5 | 3 | 0 |
| 7 | Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Sichuan Bai Li Pharma Co., Ltd. romanized | 3 | 2 | 2 |
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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/12/07Generic · Class 3 | Amisulpride Oral SolutionCYHS2102152 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2021/12/07New drug · Class 1 | SK10散 · No verified English nameCXSL2101470 | Guangzhou Zhi Yi Bio Technology Co., Ltd. romanized |
| 2021/12/07New drug · Class 1 | LBL-007注射液 · No verified English nameCXSL2101469 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2021/12/07New drug · Class 1 | 注射用QLS31906 · No verified English nameCXSL2101467 | Qilu Pharmaceutical Co., Ltd. |
| 2021/12/07New drug · Class 1 | YH002注射液 · No verified English nameCXSL2101465 | Name not romanized |
| 2021/12/07New drug · Class 1 | YH001注射液 · No verified English nameCXSL2101464 | Name not romanized |
| 2021/12/07New drug · Class 1 | LF0376片 · No verified English nameCXHL2101714 | Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/07New drug · Class 1 | LF0376片 · No verified English nameCXHL2101713 | Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/12/06Import · Class 1 | Enavogliflozin 片 · No verified English nameJXHL2101266 | Daewoong Pharmaceutical Co. Ltd.; Beijing Daewoong Pharmaceutical R&D Center Co. Ltd. |
| 2021/12/06Generic · Class 3 | Olopatadine Hydrochloride GranulesCYHS2102147 | Beijing Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2021/12/06Generic · Class 3 | Ornidazole InjectionCYHS2102143 | Beijing Fu Kang Ren Biopharmaceutical Technology Co., Ltd. romanized; Shanxi Nuo Cheng Pharmaceutical Co., Ltd. romanized |
| 2021/12/06Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHS2102139 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/12/06Generic · Class 3 | Guanfacine Hydrochloride Extended Release TabletsCYHS2102138 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/12/06Generic · Class 3 | Propranolol hydrochloride oral solutionCYHS2102137 | Shaanxi Bu Zhang Pharmaceutical Co., Ltd. romanized; Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized |
| 2021/12/06Generic · Class 3 | Desmopressin Acetate Oral SolutionCYHS2102129 | Nanjing Healthnice Pharmaceutical Technology Co., Ltd; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized |
| 2021/12/06Generic · Class 3 | Imidafenacin TabletsCYHL2101047 | Nanjing Pharmaceutical Factory Co., Ltd. romanized |
| 2021/12/06New drug · Class 1 | SH006注射液 · No verified English nameCXSL2101463 | Nanjing Sheng He Pharma Co., Ltd. romanized |
| 2021/12/06New drug · Class 1 | SI-B001双特异性抗体注射液 · No verified English nameCXSL2101461 | Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2021/12/06New drug · Class 2.2 | 注射用伊尼妥单抗 · No verified English nameCXSL2101459 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2021/12/06New drug · Class 1 | GZR4 · No verified English nameCXSL2101457 | Gan Li Pharma Co., Ltd. romanized |
| 2021/12/06New drug · Class 2.4 | 奥布替尼片 · No verified English nameCXHL2101710 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 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 |
22 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.