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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 80 drug applications between 2 February 2022 and 8 February 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 12 drug names.

2022/02/02 – 2022/02/08

Period
2022/02/02 to 2022/02/08, 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
80
Drugs with new generic filings (by drug name, de-duplicated)
12
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

80filings, 20 of them generic

By application type

Application typeFilings
Supplement33
Generic20
New drug14
Import10
Import re-registration2
Unspecified1

By drug type

Drug typeFilings
Chemical drug61
Therapeutic biologic10
TCM8
Prophylactic 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

12 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets515
2Rivaroxaban Tablets323
3Empagliflozin Tablets2118
4Esomeprazole Magnesium Enteric-Coated Capsules214
5利奈唑胺氯化钠注射液 · No verified English name110
6氧 · No verified English name1115
7Sodium Hyaluronate Eye Drops1130
8Memantine Hydrochloride Oral Solution110
9Amantadine Hydrochloride Tablets110
10Calcium Gluconate Injection115

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

50 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1AstraZeneca AB510
2Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized515
3Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized310
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized310
5CSPC OUYI PHARMACEUTICAL CO., LTD.310
6Jilin Tian Heng Pharma Co., Ltd. romanized221
7Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized220
8Hainan Brilliant Pharmaceutical Co., Ltd.220
9Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized220
10Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized220

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

28 this week

AcceptedDrugApplicants
2022/02/08Import · Class 2.4 Ibrexafungerp片 · No verified English nameJXHL2200036 SCYNEXIS Inc.; JIANGSU HANSOH PHARMACEUTICAL GROUP CO. LTD
2022/02/08Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2200278 Suzhou Te Rui Pharma Co., Ltd. romanized
2022/02/08Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2200277 Suzhou Te Rui Pharma Co., Ltd. romanized
2022/02/08Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200276 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2022/02/08Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200275 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2022/02/08Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200274 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2022/02/08Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200273 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2022/02/08Generic · Class 3 Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2200272 Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized
2022/02/08Generic · Class 3 Amantadine Hydrochloride TabletsCYHS2200269 Zhejiang Apeloa Kangyu Pharmaceutical Co., Ltd.
2022/02/08Generic · Class 3 Calcium Gluconate InjectionCYHS2200264 Hubei Xin Ze Fei Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2022/02/08Generic · Class 3 Memantine Hydrochloride Oral SolutionCYHS2200221 Hangzhou He Kang Pharma Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized
2022/02/08New drug · Class 1.2 开拓普片 · No verified English nameCXZL2200007 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2022/02/08New drug · Class 1.2 梓醇 · No verified English nameCXZL2200006 Suzhou Yu Sen Xin Yao Kai Fa Co., Ltd. romanized
2022/02/08New drug · Class 1.1 枣柏安神颗粒 · No verified English nameCXZL2200004 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2022/02/08New drug · Class 1 QL1706注射液 · No verified English nameCXSL2200076 Qilu Pharmaceutical Co., Ltd.
2022/02/08New drug · Class 1 注射用BL-M02D1 · No verified English nameCXSL2200075 Sichuan Bai Li Pharma Co., Ltd. romanized; Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized
2022/02/08New drug · Class 1 3D-229注射液 · No verified English nameCXSL2200073 Xu Zhou Si Lu Di Pharma Co., Ltd. romanized
2022/02/08New drug · Class 1 HSK36212胶囊 · No verified English nameCXHL2200075 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2022/02/08New drug · Class 1 HSK36212胶囊 · No verified English nameCXHL2200074 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2022/02/08New drug · Class 1 HSK36212胶囊 · No verified English nameCXHL2200073 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2022/02/07Import · Class 2.2 诺西那生钠注射液 · No verified English nameJXHL2200035 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/02/07Import · Class 2.2 诺西那生钠注射液 · No verified English nameJXHL2200034 Biogen Idec Research Limited; Biogen Biotechnology (Shanghai) Co. Ltd
2022/02/07Generic · Class 3 利奈唑胺氯化钠注射液 · No verified English nameCYHS2200067 Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized
2022/02/07New drug · Class 3.4 注射用重组人凝血因子Ⅷ · No verified English nameCXSS2200013 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/02/07New drug · Class 1 SHR-2004注射液 · No verified English nameCXSL2200072 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/02/07New drug · Class 1 TQH2722注射液 · No verified English nameCXSL2200071 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2022/02/07New drug · Class 1 重组人源化抗PD-1单克隆抗体注射液 · No verified English nameCXSL2200069 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized
2022/02/07New drug · Class 1 重组全人源抗人表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2200068 Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized

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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