YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 268 drug applications between 24 December 2021 and 30 December 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 44 drug names.

2021/12/24 – 2021/12/30

Period
2021/12/24 to 2021/12/30, 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
268
Drugs with new generic filings (by drug name, de-duplicated)
44
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

268filings, 68 of them generic

By application type

Application typeFilings
Supplement100
Generic68
New drug68
Import16
Unspecified9
Import re-registration6
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug199
Therapeutic biologic44
TCM20
Biologic2
Prophylactic biologic2
Drug-device combination1

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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ticagrelor Tablets3210
2Tranexamic Acid Injection3211
3Venlafaxine Hydrochloride Sustained-Release Capsules320
4Sildenafil Citrate Tablets3112
5阿普米司特片 · No verified English name313
6Glucosamine Sulfate Capsules2251
7Olanzapine Orally Disintegrating Tablets210
8Torsemide Injection211
9Sacubitril Valsartan Sodium Tablets2170
10Nicorandil for Injection211

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

165 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hua Run Shuang He Pharma Co., Ltd. romanized753
2Yang Zi Jiang Pharma Group Jiangsu Pharmaceutical Co., Ltd. romanized660
3Guangdong Ke Lun Pharma Co., Ltd. romanized510
4Guangzhou Run Er Yan Ke Bio Technology Co., Ltd. romanized510
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized440
6Beijing Rui Ye Pharmaceutical Co., Ltd. romanized422
7Bioverativ Therapeutics Inc410
8Shanghai Ying Li Pharma Co., Ltd. romanized410
9Guangxi Sheng Min Pharmaceutical Co., Ltd. romanized330
10Zhejiang Wo Wu Bio Technology Co., Ltd. romanized330

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

105 this week

AcceptedDrugApplicants
2021/12/30Import · Class 3.1 注射用维博妥珠单抗 · No verified English nameJXSS2101037 Roche Pharma (Schweiz)AG; F. Hoffmann-La Roche AG
2021/12/30Import · Class 3.1 注射用维博妥珠单抗 · No verified English nameJXSS2101036 Roche Pharma (Schweiz)AG; BSP Pharmaceuticals S.p.A.
2021/12/30Import · Class 1 Sepantronium Bromide注射液 · No verified English nameJXHL2101289 Cothera Bioscience Inc.; Beijing Percans Oncology Co. Ltd.
2021/12/30Generic · Class 3 Thioctic Acid TabletsCYHS2102326 Ya Bao Pharma Group Co., Ltd. romanized
2021/12/30Generic · Class 3 Thioctic Acid TabletsCYHS2102325 Ya Bao Pharma Group Co., Ltd. romanized
2021/12/30Generic · Class 3 Ornidazole InjectionCYHS2102322 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2021/12/30Generic · Class 3 注射用盐酸头孢吡肟/氯化钠注射液 · No verified English nameCYHS2102321 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/12/30Generic · Class 3 注射用盐酸头孢吡肟/氯化钠注射液 · No verified English nameCYHS2102318 Beijing Rui Ye Pharmaceutical Co., Ltd. romanized
2021/12/30Generic · Class 3 Tranexamic Acid InjectionCYHS2102317 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2021/12/30Generic · Class 3 Tranexamic Acid InjectionCYHS2102316 Jin Zhou Ao Hong Pharma Co., Ltd. romanized
2021/12/30New drug · Class 1.1 秦苓颗粒 · No verified English nameCXZL2101043 Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized
2021/12/30New drug · Class 1.1 驹藿片 · No verified English nameCXZL2101042 Beijing Niu Wei Po Ao Pharmaceuticals Technology Co., Ltd. romanized
2021/12/30New drug · Class 1.1 牛贝消核颗粒 · No verified English nameCXZL2101041 Guangdong Qi Fang Pharma Co., Ltd. romanized
2021/12/30New drug · Class 3.3 乌司奴单抗注射液 · No verified English nameCXSL2101529 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2021/12/30New drug · Class 1 注射用BAT8006 · No verified English nameCXSL2101528 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2021/12/30New drug · Class 1 ZL-1211注射液 · No verified English nameCXSL2101527 Zai Chuang Biopharmaceuticals (Suzhou) Co., Ltd. romanized
2021/12/30New drug · Class 1 PM1032 注射液 · No verified English nameCXSL2101520 Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized
2021/12/30New drug · Class 1 IBI110 · No verified English nameCXSL2101516 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2021/12/30New drug · Class 2.2 左乙拉西坦缓释颗粒 · No verified English nameCXHL2101849 Shanghai An Bi Sheng Pharmaceutical Technology Co., Ltd. romanized
2021/12/30New drug · Class 1 SR1375胶囊 · No verified English nameCXHL2101848 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2021/12/30New drug · Class 1 SR1375胶囊 · No verified English nameCXHL2101847 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2021/12/30New drug · Class 1 SR1375胶囊 · No verified English nameCXHL2101846 Shanghai Sai Mo Luo De Bio Technology Co., Ltd. romanized
2021/12/30New drug · Class 1 TDI01混悬液 · No verified English nameCXHL2101824 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2021/12/30New drug · Class 2.4 替戈拉生片 · No verified English nameCXHL2101815 Shandong Luo Xin Pharma Group Co., Ltd. romanized
2021/12/29Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHL2101058 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2021/12/29Generic · Class 3 Guanfacine Hydrochloride Extended Release TabletsCYHL2101057 Nanjing Healthnice Pharmaceutical Technology Co., Ltd
2021/12/29New drug · Class 1 CTA101 UCAR T细胞注射液 · No verified English nameCXSL2101509 Nanjing Bei Heng Biopharmaceuticals Co., Ltd. romanized; Nanjing Bei Heng Bio Technology Co., Ltd. romanized
2021/12/29New drug · Class 1 LIT-00505胶囊 · No verified English nameCXHL2101845 Shanghai Hui Qi Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/29New drug · Class 1 LIT-00505胶囊 · No verified English nameCXHL2101844 Shanghai Hui Qi Biopharmaceuticals Technology Co., Ltd. romanized
2021/12/29New drug · Class 1 LIT-00505胶囊 · No verified English nameCXHL2101843 Shanghai Hui Qi Biopharmaceuticals Technology Co., Ltd. romanized

75 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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