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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 317 drug applications between 13 September 2024 and 19 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 54 drug names.

2024/09/13 – 2024/09/19

Period
2024/09/13 to 2024/09/19, 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
317
Drugs with new generic filings (by drug name, de-duplicated)
54
Accepted this week, now under review
6

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

317filings, 77 of them generic

By application type

Application typeFilings
Supplement155
Generic77
New drug64
Import15
Import re-registration5
Unspecified1

By drug type

Drug typeFilings
Chemical drug220
TCM50
Therapeutic biologic38
Prophylactic biologic8
Biologic1

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

54 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Brexpiprazole Tablets6231
2Minoxidil Liniment4252
3Ambroxol Hydrochloride Oral Solution4146
4Alanyl Glutamine Injection214
5Ipratropium Bromide Inhalation Solution212
6Pregabalin Orally Disintegrating Tablets213
7Tandospirone Citrate Tablets212
8Sildenafil Citrate Tablets2112
9Vortioxetine Hydrobromide Tablets2110
10氯化钙注射液 · No verified English name216

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

172 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Xin Wan Lian Pharmaceuticals Co., Ltd. romanized35350
2Anhui An Ke Bio Gong Cheng (Group) Co., Ltd. romanized1030
3Qilu Pharmaceutical Co., Ltd.941
4Jiangsu Xiu Zheng Pharmaceutical Co., Ltd. romanized550
5AstraZeneca AB540
6Pfizer Europe MA EEIG530
7Anhui Tai En Kang Pharmaceutical Co., Ltd. romanized525
8Hua Ren Pharma Co., Ltd. romanized510
9Shanxi Ren Yuan Tang Pharma Co., Ltd. romanized440
10Jiangxi Xing Lin Bai Ma Pharma 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

109 this week

AcceptedDrugApplicants
2024/09/19Import · Class 1 Volixibat胶囊 · No verified English nameJXHL2400220 Mirum Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd.
2024/09/19Import · Class 1 Volixibat胶囊 · No verified English nameJXHL2400219 Mirum Pharmaceuticals Inc.; Syneos Health(Beijing)Inc. Ltd.
2024/09/19Generic · Class 3 Sodium Picosulfate, Magnesium Oxide, And Anhydrous Citric Acid Oral SolutionCYHS2403122 Zhejiang Tong Wu Biopharmaceuticals Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/09/19Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2403117 Beijing Min Kang Bai Cao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2024/09/19Generic · Class 3 Sulindac TabletsCYHS2403116 Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized; Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized
2024/09/19Generic · Class 3 Sulindac TabletsCYHS2403115 Gan Zheng (Hainan) Bio Pharma Co., Ltd. romanized; Hainan Ke Jin Biopharmaceutical Co., Ltd. romanized
2024/09/19Generic · Class 3 Polymyxin B sulfate for InjectionCYHS2403113 Qilu Pharmaceutical (Hainan) Co., Ltd
2024/09/19Generic · Class 3 Relugolix TabletsCYHL2400191 Qilu Pharmaceutical Co., Ltd.
2024/09/19Generic · Class 3 米诺地尔泡沫剂 · No verified English nameCYHL2400190 Zhejiang San Sheng Man Di Pharma Co., Ltd. romanized
2024/09/19Generic · Class 3 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400189 Hubei Yuan Da Tian Tian Ming Pharmaceutical Co., Ltd. romanized
2024/09/19New drug · Class 3.1 桃红四物颗粒 · No verified English nameCXZS2400031 Zhu Zhou Qian Jin Pharma Co., Ltd. romanized
2024/09/19New drug · Class 1.1 十味疏风颗粒 · No verified English nameCXZL2400055 Shandong Sheng Yao Xue Ke College romanized; Hangzhou Yuan Cao Pharma Co., Ltd. romanized
2024/09/19New drug · Class 2.3 黄蛭益肾胶囊 · No verified English nameCXZL2400054 Lei Yun Shang Pharma Group Co., Ltd. romanized
2024/09/19New drug · Class 1.1 四仙颗粒 · No verified English nameCXZL2400053 Sichuan Sheng Zhong Pharmaceuticals Ke College romanized
2024/09/19New drug · Class 3.3 流感病毒亚单位疫苗 · No verified English nameCXSS2400100 Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized
2024/09/19New drug · Class 1 MC-1-50细胞制剂 · No verified English nameCXSL2400632 Chongqing Jing Zhun Bio Technology Co., Ltd. romanized
2024/09/19New drug · Class 1 MWN105注射液 · No verified English nameCXSL2400631 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2024/09/19New drug · Class 1 IMM0306 · No verified English nameCXSL2400630 Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2024/09/19New drug · Class 2.2 四价流感病毒裂解疫苗(MDCK细胞) · No verified English nameCXSL2400629 Ai Mei Cheng Xin Biopharmaceutical Co., Ltd. romanized; Ai Mei Yi Miao Co., Ltd. romanized; Ai Mei Tan Suo Zhe Sheng Ming Ke Xue Research and Development Co., Ltd. romanized; Lanzhou Bai Ling Bio Technology Co., Ltd. romanized
2024/09/19New drug · Class 1 TDM-180935软膏 · No verified English nameCXHL2400985 Te Ke Luo Bio Technology (Chengdu) Co., Ltd. romanized
2024/09/19New drug · Class 1 TDM-180935软膏 · No verified English nameCXHL2400984 Te Ke Luo Bio Technology (Chengdu) Co., Ltd. romanized
2024/09/19New drug · Class 1 TDM-180935软膏 · No verified English nameCXHL2400983 Te Ke Luo Bio Technology (Chengdu) Co., Ltd. romanized
2024/09/19New drug · Class 1 注射用苯磺酸CG-0255 · No verified English nameCXHL2400982 Shanghai Ke Jun Pharmaceuticals Technology Co., Ltd. romanized
2024/09/19New drug · Class 2.3 SMF-211 · No verified English nameCXHL2400981 Jiangxi Shimei Pharmaceutical Co., Ltd
2024/09/19New drug · Class 2.4 利马前列素片 · No verified English nameCXHL2400980 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2024/09/18New drug · Class 1 注射用BG-T187 · No verified English nameCXSL2400628 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2024/09/18New drug · Class 1 奥美克松钠注射液 · No verified English nameCXHS2400096 Hangzhou Ao Mo Pharmaceuticals Co., Ltd. romanized; Zhejiang Xian Ju Pharmaceutical Co., Ltd. romanized
2024/09/18New drug · Class 1 CTS3497胶囊 · No verified English nameCXHL2400979 Sai Lan (Hangzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2024/09/18New drug · Class 1 CTS3497胶囊 · No verified English nameCXHL2400978 Sai Lan (Hangzhou) Biopharmaceuticals Technology Co., Ltd. romanized
2024/09/18New drug · Class 1 HRS-3802缓释片 · No verified English nameCXHL2400977 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized

79 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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