YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 282 drug applications between 5 December 2021 and 11 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 42 drug names.

2021/12/05 – 2021/12/11

Period
2021/12/05 to 2021/12/11, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
282
Drugs with new generic filings (by drug name, de-duplicated)
42
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

282filings, 51 of them generic

By application type

Application typeFilings
Supplement160
Generic51
New drug41
Import14
Import re-registration11
Unspecified5

By drug type

Drug typeFilings
Chemical drug188
TCM46
Therapeutic biologic46
Prophylactic biologic2

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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1阿普米司特片 · No verified English name313
2Tofacitinib Citrate Tablets221
3Candesartan Cilexetil and Hydrochlorothiazide Tablets210
4Rifampin For Injection212
5Guanfacine Hydrochloride Extended Release Tablets214
6Valsartan Film-Coated Tablets210
7Carbocisteine Oral Solution216
8Febuxostat Tablets2112
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

160 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized15140
2Da Lian Jin Ding Chang Pharmaceuticals Technology Co., Ltd. romanized11110
3Xian Ge Lan Xin Tong Pharmaceutical Co., Ltd. romanized990
4medac Gesellschaft für klinische Spezialpr?parate mbH810
5Shenzhen Xin Li Tai Pharma Co., Ltd. romanized610
6Shaanxi Chang Ming Pharmaceutical Co., Ltd. romanized550
7Ha Yao Group Zhong Yao Er Factory romanized540
8Yi Chang Ren Fu Pharma Co., Ltd. romanized432
9Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized421
10Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized420

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

59 this week

AcceptedDrugApplicants
2021/12/10Import · Class 3.1 Tisotumab Vedotin · No verified English nameJXSL2101146 Seagen Inc.; PRA Health Sciences China Inc.
2021/12/10New drug · Class 2.2 注射用维迪西妥单抗 · No verified English nameCXSL2101475 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2021/12/10New drug · Class 1 THZ0106注射液 · No verified English nameCXSL2101473 Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized
2021/12/10New drug · Class 1 人源化抗人 IgE 单克隆抗体注射液 · No verified English nameCXSL2101472 Tian Chen Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/12/10New drug · Class 1 BC0306胶囊 · No verified English nameCXHL2101733 Shandong Dan Hong Pharmaceutical Co., Ltd. romanized
2021/12/10New drug · Class 1 BC0306胶囊 · No verified English nameCXHL2101732 Shandong Dan Hong Pharmaceutical Co., Ltd. romanized
2021/12/10New drug · Class 1 LF0397片 · No verified English nameCXHL2101716 Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/10New drug · Class 1 LF0397片 · No verified English nameCXHL2101715 Shenzhen Shi Ling Fang Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/09Import · Class 1 人同种异体骨髓来源的成骨细胞 · No verified English nameJXSL2101145 Bone Therapeutics SA; SHENZHEN PREGENE BIOPHARMA CO. LTD
2021/12/09Generic · Class 3 Lansoprazole For InjectionCYHS2102174 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2021/12/09Generic · Class 3 Carbocisteine Oral SolutionCYHS2102169 Beijing Yi Jia Xin Chuang Medical Devices Technology Research Institute Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2021/12/09Generic · Class 3 Carbocisteine Oral SolutionCYHS2102168 Beijing Yi Jia Xin Chuang Medical Devices Technology Research Institute Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized
2021/12/09New drug · Class 1.1 全三七片 · No verified English nameCXZL2101039 Yunnan Bai Yao Group Co., Ltd. romanized
2021/12/09New drug · Class 1 注射用CU-20401 · No verified English nameCXSL2101474 Ke Di Biopharmaceuticals (Wuxi) Co., Ltd. romanized
2021/12/09New drug · Class 1 KF-0210片 · No verified English nameCXHL2101731 Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2021/12/09New drug · Class 1 KF-0210片 · No verified English nameCXHL2101730 Kai Fu (Suzhou) Biopharmaceuticals Co., Ltd. romanized
2021/12/08Generic · Class 3 Pregabalin Oral SolutionCYHS2102160 Qin Huang Dao Ai Hui Pharma Co., Ltd. romanized; Bao Ding Ai Hui Pharma Co., Ltd. romanized
2021/12/08Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2102158 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2021/12/08Generic · Class 3 Candesartan Cilexetil and Hydrochlorothiazide TabletsCYHS2102157 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2021/12/08Generic · Class 3 Nicorandil for InjectionCYHS2102156 Chengdu Easton Biopharmaceuticals Co.,Ltd.; Shanxi Pu De Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 HB0028注射液 · No verified English nameCXSL2101471 Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized; Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 KN060注射液 · No verified English nameCXSL2101468 Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized
2021/12/08New drug · Class 1 LNF1904 · No verified English nameCXSL2101466 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 QY201片 · No verified English nameCXHL2101729 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2021/12/08New drug · Class 1 QY201片 · No verified English nameCXHL2101728 Qi Yuan Bio (Hangzhou) Co., Ltd. romanized
2021/12/08New drug · Class 1 盐酸BGB-23339薄膜包衣片 · No verified English nameCXHL2101727 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/12/08New drug · Class 1 盐酸BGB-23339薄膜包衣片 · No verified English nameCXHL2101726 Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized
2021/12/08New drug · Class 1 PRJ1-3024胶囊 · No verified English nameCXHL2101725 Zhuhai Yu Fan Bio Technology Co., Ltd. romanized
2021/12/08New drug · Class 1 SAL0114片 · No verified English nameCXHL2101724 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2021/12/08New drug · Class 1 SAL0114片 · No verified English nameCXHL2101723 Shenzhen Xin Li Tai Pharma Co., Ltd. romanized

29 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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