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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 399 drug applications between 22 December 2023 and 28 December 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 84 drug names.

2023/12/22 – 2023/12/28

Period
2023/12/22 to 2023/12/28, 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
399
Drugs with new generic filings (by drug name, de-duplicated)
84
Accepted this week, now under review
1

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

399filings, 122 of them generic

By application type

Application typeFilings
Supplement169
Generic122
New drug73
Import21
Import re-registration9
Unspecified5

By drug type

Drug typeFilings
Chemical drug293
TCM54
Therapeutic biologic46
Prophylactic biologic6

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

84 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Vonoprazan Fumarate Tablets4260
2Levofloxacin and Sodium Chloride Injection4214
3注射用头孢唑肟钠 · No verified English name424
4Azilsartan Medoxomil Potassium Tablets4235
5Penicillin G Sodium For Injection412
6Potassium Chloride Injection3210
7Sitagliptin and Metformin Hydrochloride Extended-release Tablets3212
8Ketorolac Tromethamine Injection324
9Sodium Valproate Sustained-release Tablets(I)224
10Lidocaine and Prilocaine Cream2224

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

236 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Bo Rui Xin Chuang Biopharmaceuticals Technology (Wuxi) Co., Ltd. romanized1410
2Shenyang Hong Yao Group Co., Ltd. romanized760
3AstraZeneca AB740
4Guangzhou Bai Yun Shan Tian Xin Pharmaceutical Co., Ltd. romanized740
5Beijing Bu Lin Bio Technology Co., Ltd. romanized646
6Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized620
7Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized555
8Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized550
9Chengdu Bei Te Biopharmaceutical Co., Ltd. romanized510
10Ha Yao Group San Jing Qian He Pharmaceutical Co., Ltd. romanized440

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

148 this week

AcceptedDrugApplicants
2023/12/28Import · Class 2.2 Cemiplimab · No verified English nameJXSL2300237 Regeneron Ireland Designated Activity Company (DAC); Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2023/12/28Import · Class 3.4 注射用CU-20101 · No verified English nameJXSL2300236 CKD BiO Corporation
2023/12/28Import · Class 1 M1774胶囊 · No verified English nameJXHL2300330 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2023/12/28Import · Class 1 M1774胶囊 · No verified English nameJXHL2300329 Merck Healthcare KGaA; Merck Serono (Beijing) Pharmaceutical R&D Co. Ltd
2023/12/28Generic · Class 3 吲哚美辛凝胶贴膏 · No verified English nameCYHS2303665 Hunan Jiudian Pharmaceutical Co., Ltd
2023/12/28Generic · Class 3 Methocarbamol InjectionCYHS2303661 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Yin Gu Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2303660 Chongqing Huapont Pharmaceutical Co., Ltd.
2023/12/28Generic · Class 3 Penicillin G Sodium For InjectionCYHS2303653 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Penicillin G Sodium For InjectionCYHS2303652 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Penicillin G Sodium For InjectionCYHS2303651 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Penicillin G Sodium For InjectionCYHS2303650 Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 地氯雷他定口服溶液 · No verified English nameCYHS2303649 Jiangsu Dong Ke Kang De Pharma Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 硝普钠氯化钠注射液 · No verified English nameCYHS2303648 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303646 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2303645 Zhejiang Gao Zhi Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/12/28Generic · Class 3 Candesartan Cilexetil And Amlodipine Besylate TabletsCYHL2300165 Jiangxi Shimei Pharmaceutical Co., Ltd
2023/12/28Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2300164 CSPC OUYI PHARMACEUTICAL CO., LTD.
2023/12/28Generic · Class 3 地塞米松眼内插入剂 · No verified English nameCYHL2300163 Beijing Ren Zhong Pharma Co., Ltd. romanized
2023/12/28Generic · Class 3 Mannitol-S InjectionCYHL2300162 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2023/12/28New drug · Class 1 注射用BL-M05D1 · No verified English nameCXSL2300904 Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized
2023/12/28New drug · Class 1 CUD005注射液 · No verified English nameCXSL2300903 Sichuan Kang De Sai Medical Technology Co., Ltd. romanized
2023/12/28New drug · Class 1.3 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2300902 Anhui Zhi Fei Long Ke Ma Biopharmaceutical Co., Ltd. romanized
2023/12/28New drug · Class 2.5 冻干人用狂犬病疫苗(Vero细胞) · No verified English nameCXSL2300901 Shandong Yi Du Bio Technology Co., Ltd. romanized
2023/12/28New drug · Class 1 SCTB35注射液 · No verified English nameCXSL2300900 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2023/12/28New drug · Class 1 注射用重组抗PD1/TIM3人源化双特异抗体 · No verified English nameCXSL2300899 Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized
2023/12/28New drug · Class 1 注射用LB4330 · No verified English nameCXSL2300898 Shanghai Jian Xin Biopharmaceuticals Technology Co., Ltd. romanized
2023/12/28New drug · Class 1 JL18008注射液 · No verified English nameCXSL2300897 Jie Ku (Shanghai) Biopharmaceuticals Research Co., Ltd. romanized
2023/12/28New drug · Class 2.4 TAP-1503乳膏 · No verified English nameCXHS2300119 Shanghai Ze De Man Pharmaceuticals Technology Co., Ltd. romanized; Shanghai Xin Ya Pharma Min Xing Co., Ltd. romanized
2023/12/28New drug · Class 1 WS-0101溶液 · No verified English nameCXHL2301464 Name not romanized
2023/12/28New drug · Class 2.2 NF2105胶囊 · No verified English nameCXHL2301463 Shenzhen Shi Tai Li Biopharmaceuticals Co., Ltd. romanized

118 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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