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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 249 drug applications between 3 August 2022 and 9 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 44 drug names.

2022/08/03 – 2022/08/09

Period
2022/08/03 to 2022/08/09, 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
249
Drugs with new generic filings (by drug name, de-duplicated)
44
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

249filings, 53 of them generic

By application type

Application typeFilings
Supplement126
Generic53
New drug44
Import13
Unspecified8
Import re-registration4
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug175
TCM43
Therapeutic biologic26
Prophylactic biologic3
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

44 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ozagrel Sodium Injection423
2Salbutamol Sulfate Inhalation Solution312
3Acetylcysteine Granules214
4头孢呋辛酯干混悬剂 · No verified English name215
5Ornidazole Injection210
6Gadobutrol Injection218
7丁酸氯维地平乳状注射液 · No verified English name110
8Tadalafil Tablets1123
9低钙腹膜透析液(乳酸盐-G1.5%) · No verified English name113
10低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name114

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

139 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.40350
2Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized810
3Celgene Corporation610
4Boehringer Ingelheim International GmbH550
5Dong Ling Pharma Technology (Liaoning) Co., Ltd. romanized550
6Guangxi Xiu Zheng Pharmaceutical Co., Ltd. romanized530
7Shijiazhuang No.4 Pharmaceutical Co., Ltd.535
8Shanxi Tong Da Pharma Co., Ltd. romanized440
9Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized430
10Guizhou De Liang Fang Pharma 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

83 this week

AcceptedDrugApplicants
2022/08/09Generic · Class 3 Isoniazid InjectionCYHS2201267 Shenyang Shuang Ding Pharmaceutical Co., Ltd. romanized
2022/08/09Generic · Class 3 Ibuprofen GranulesCYHS2201266 Rui Yang Pharmaceutical Co., Ltd. romanized
2022/08/09Generic · Class 3 丁酸氯维地平乳状注射液 · No verified English nameCYHS2201262 Nanjing You Ke Pharmaceutical Co., Ltd. romanized
2022/08/09Generic · Class 3 核黄素磷酸钠滴眼液 · No verified English nameCYHS2201261 Ningxia Kang Ya Pharma Co., Ltd. romanized
2022/08/09Generic · Class 3 Esmolol Hydrochloride InjectionCYHS2201260 Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized
2022/08/09Generic · Class 3 Salbutamol Sulfate Inhalation SolutionCYHS2201258 Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized
2022/08/09Generic · Class 3 Salbutamol Sulfate Inhalation SolutionCYHS2201257 Li Sheng Pharmaceuticals (Suzhou) Co., Ltd. romanized
2022/08/09New drug · Class 1 HLX60 · No verified English nameCXSL2200366 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized
2022/08/08Generic · Class 3 Carbazochrome Sodium Sulfonate InjectionCYHS2201256 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2022/08/08Generic · Class 3 Ampicillin Sodium For InjectionCYHS2201253 Shanxi Ming Yu Bio Technology Co., Ltd. romanized; Shandong Lukang Pharmaceutical Co.,Ltd.
2022/08/08Generic · Class 3 Aripiprazole Oral SolutionCYHS2201251 Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; Zhong Fu Pharma Co., Ltd. romanized
2022/08/08Generic · Class 3 Ornidazole InjectionCYHS2201250 Xian Xin Bai Xin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2022/08/08Generic · Class 3 Ornidazole InjectionCYHS2201249 Xian Xin Bai Xin Pharmaceuticals Technology Co., Ltd. romanized; Tai Ji Group Sichuan Tai Ji Pharmaceutical Co., Ltd. romanized
2022/08/08Generic · Class 3 Citicoline Sodium InjectionCYHS2201248 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/08/08Generic · Class 3 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English nameCYHS2201233 Anhui Feng Yuan Pharma Co., Ltd. romanized
2022/08/08Generic · Class 3 低钙腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2201232 Anhui Feng Yuan Pharma Co., Ltd. romanized
2022/08/08New drug · Class 1.1 通降颗粒 · No verified English nameCXZL2200037 Jian Min Pharma Group Co., Ltd. romanized
2022/08/08New drug · Class 2.3 舒肝解郁胶囊 · No verified English nameCXZL2200036 Sichuan Ji Sheng Tang Pharma Co., Ltd. romanized
2022/08/08New drug · Class 1 欧司珀利单抗注射液 · No verified English nameCXSL2200365 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2022/08/08New drug · Class 1 重组人源化抗BTLA单克隆抗体注射液 · No verified English nameCXSL2200364 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2022/08/08New drug · Class 1 LBL-007注射液 · No verified English nameCXSL2200363 Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized
2022/08/08New drug · Class 3.4 聚乙二醇化人粒细胞刺激因子注射液 · No verified English nameCXSL2200346 Ke Xing Biopharmaceutical Co., Ltd. romanized
2022/08/08New drug · Class 2.1 盐酸左沙丁胺醇异丙托溴铵吸入溶液 · No verified English nameCXHL2200575 Jiangsu He Chen Pharma Co., Ltd. romanized
2022/08/08New drug · Class 2.4 Lidocaine CataplasmsCXHL2200574 Beijing Tai De Pharmaceutical Co., Ltd. romanized
2022/08/08New drug · Class 1 BEBT-503胶囊 · No verified English nameCXHL2200573 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/08/08New drug · Class 1 BEBT-503胶囊 · No verified English nameCXHL2200572 Guangzhou Bi Bei Te Pharmaceuticals Co., Ltd. romanized
2022/08/08New drug · Class 2.2 盐酸溴己新分散片 · No verified English nameCXHL2200560 Jiangxi Yi You Pharma Co., Ltd. romanized
2022/08/08New drug · Class 2.2 盐酸溴己新分散片 · No verified English nameCXHL2200559 Jiangxi Yi You Pharma Co., Ltd. romanized
2022/08/05Import · Class 1 BMS-986256胶囊 · No verified English nameJXHL2200235 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2022/08/05Import · Class 1 BMS-986256胶囊 · No verified English nameJXHL2200234 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.

53 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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