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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

Period
2021/12/01 to 2021/12/07, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement116
Generic55
New drug26
Import13
Unspecified11
Import re-registration10

By drug type

Drug typeFilings
Chemical drug157
TCM43
Therapeutic biologic28
Biologic3

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

#DrugNew generic filingsFiling companiesUnder review, all years
1Rabeprazole Sodium Enteric-coated Tablets320
2Lactulose Oral Solution3134
3Pregabalin Capsules2112
4Rifampin For Injection212
5Cefminox Sodium for Injection210
6Palonosetron Hydrochloride Injection211
7Guanfacine Hydrochloride Extended Release Tablets214
8Sitagliptin Phosphate Tablets212
9Acetylcysteine Effervescent Tablets113
10Tadalafil Tablets1123

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)FilingsDrugsGeneric
1Jilin Ao Dong Yan Bian Pharma Co., Ltd. romanized10100
2Hua Run Shuang He Pharma Co., Ltd. romanized1070
3Wuhan Ai Min Pharmaceutical Co., Ltd. romanized660
4Novartis Pharma AG630
5Shaanxi Chang Ming Pharmaceutical Co., Ltd. romanized550
6Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized530
7Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized440
8Jilin Sheng Yi Pu Bio Technology Co., Ltd. romanized330
9Hainan Tao Sheng Pharmaceuticals Technology Research Institute Co., Ltd. romanized330
10Sichuan Bai Li Pharma Co., Ltd. romanized322

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

AcceptedDrugApplicants
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.

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