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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 187 drug applications between 6 April 2022 and 12 April 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 48, covering 34 drug names.

2022/04/06 – 2022/04/12

Period
2022/04/06 to 2022/04/12, 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
187
Drugs with new generic filings (by drug name, de-duplicated)
34
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

187filings, 48 of them generic

By application type

Application typeFilings
Supplement93
Generic48
New drug26
Import14
Unspecified4
Import re-registration2

By drug type

Drug typeFilings
Chemical drug154
Therapeutic biologic21
TCM9
Prophylactic biologic3

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

34 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Cariprazine hydrochloride Capsules413
2Tadalafil Tablets3123
3Sitagliptin Phosphate Tablets312
4Etoricoxib Tablets218
5Piracetam Injection219
6Levofloxacin Eye Drops2116
7Lacosamide Tablets210
8Omeprazole Sodium for Injection213
9Ondansetron Hydrochloride Tablets216
10Oxytocin Injection218

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

120 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Anhui Sheng Yi Feng Tang Technology Co., Ltd. romanized650
2Boehringer Ingelheim International GmbH510
3Sanofi -aventis France510
4Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized434
5Shijiazhuang No.4 Pharmaceutical Co., Ltd.433
6Novo Nordisk A/S410
7Chengdu Kang Hong Pharma Group Co., Ltd. romanized414
8Chengdu Brilliant Pharmaceutical Co., Ltd.323
9Biocon Pharma Limited310
10Blueprint Medicines Corporation310

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

50 this week

AcceptedDrugApplicants
2022/04/12Import · Class 1 Tremelimumab · No verified English nameJXSL2200045 MedImmune LLC; AstraZeneca Global R&D (China) Co. Ltd.
2022/04/12Import · Class 1 JDQ443片 · No verified English nameJXHL2200085 Novartis Pharma AG; China Novartis Institutes for BioMedical Reasearch Co. Ltd
2022/04/12Generic · Class 3 洛索洛芬钠细粒剂 · No verified English nameCYHS2200568 Zhejiang Heng Yan Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2022/04/12Generic · Class 3 Roxatidine Acetate Hydrochloride For InjectionCYHS2200564 Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Jiangsu Jin Si Li Pharma Co., Ltd. romanized
2022/04/12New drug · Class 1 IBI363 · No verified English nameCXSL2200168 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2022/04/12New drug · Class 1 注射用DNV3 · No verified English nameCXSL2200167 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2022/04/12New drug · Class 1 注射用DNV3 · No verified English nameCXSL2200166 Zhejiang Shi Mai Pharma Co., Ltd. romanized
2022/04/12New drug · Class 1 ZLT-001注射液 · No verified English nameCXSL2200165 Guangzhou Zhi Ling Biopharmaceuticals Co., Ltd. romanized
2022/04/12New drug · Class 1 HRS-7983片 · No verified English nameCXHL2200231 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/04/12New drug · Class 1 HRS-7983片 · No verified English nameCXHL2200230 Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized
2022/04/11Import · Class 1 CK-3773274片 · No verified English nameJXHL2200084 Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd
2022/04/11Generic · Class 3 Oxytocin InjectionCYHS2200553 Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2022/04/11Generic · Class 3 Oxytocin InjectionCYHS2200552 Hangzhou Yun Bai Pharmaceuticals Technology Co., Ltd. romanized; Xin Xiang Shi Chang Le Pharmaceutical Co., Ltd. romanized
2022/04/11New drug · Class 2.2 斯鲁利单抗注射液 · No verified English nameCXSS2200037 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2022/04/11New drug · Class 1 TAA06注射液 · No verified English nameCXSL2200164 Bo Sheng Ji Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized
2022/04/11New drug · Class 1 安纳拉唑钠肠溶片 · No verified English nameCXHL2200229 Xuan Zhu (Beijing) Pharmaceuticals Technology Co., Ltd. romanized
2022/04/11New drug · Class 2.4; 2.1 左旋盐酸班布特罗片 · No verified English nameCXHL2200228 Dong Guan Shi Kai Fa Biopharmaceuticals Co., Ltd. romanized
2022/04/11New drug · Class 1 TT-01488片 · No verified English nameCXHL2200227 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2022/04/11New drug · Class 1 TT-01488片 · No verified English nameCXHL2200226 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2022/04/11New drug · Class 1 TT-01488片 · No verified English nameCXHL2200225 Yao Jie An Kang (Nanjing) Technology Co., Ltd. romanized
2022/04/11New drug · Class 1 KL340399注射液 · No verified English nameCXHL2200224 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/04/11New drug · Class 1 KL340399注射液 · No verified English nameCXHL2200223 Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized
2022/04/08Import · Class 1 Donanemab注射液 · No verified English nameJXSL2200044 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2022/04/08Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2200547 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/04/08Generic · Class 3 Ondansetron Hydrochloride TabletsCYHS2200546 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/04/08Generic · Class 3 利奈唑胺氯化钠注射液 · No verified English nameCYHS2200543 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2022/04/08Generic · Class 3 瑞巴派特片 · No verified English nameCYHS2200541 Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized
2022/04/08Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200031 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/04/08Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200030 Chengdu Kang Hong Pharma Group Co., Ltd. romanized
2022/04/08Generic · Class 3 Cariprazine hydrochloride CapsulesCYHL2200029 Chengdu Kang Hong Pharma Group Co., Ltd. romanized

20 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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