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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 289 drug applications between 26 February 2023 and 4 March 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 61, covering 41 drug names.

2023/02/26 – 2023/03/04

Period
2023/02/26 to 2023/03/04, 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
289
Drugs with new generic filings (by drug name, de-duplicated)
41
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

289filings, 61 of them generic

By application type

Application typeFilings
Supplement156
Generic61
New drug31
Unspecified15
Import15
Import re-registration11

By drug type

Drug typeFilings
Chemical drug197
TCM57
Therapeutic biologic25
Prophylactic biologic6
Biologic3
In vitro diagnostic reagent1

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

41 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution4234
2Dapagliflozin Tablets4284
3Phenylephrine Hydrochloride Injection325
4Ambroxol Hydrochloride Oral Solution3246
5Lidocaine and Prilocaine Cream2224
6Sodium Valproate Oral Solution211
7Tacrolimus Sustained-release Capsules216
8Carbazochrome Sodium Sulfonate Injection211
9Torsemide Injection211
10Aminophylline Injection213

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

176 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Heilongjiang Yi Da Hong Pharma Co., Ltd. romanized15140
2Guangdong Song Xia Pharma Co., Ltd. romanized11110
3NAPP PHARMACEUTICALS LIMITED910
4Bracco Imaging S.P.A.610
5Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized530
6Merck & Co. Inc.440
7Name not romanized434
8N.V. Organon420
9ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD.424
10Nei Menggu Yi Li Pharmaceutical 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

74 this week

AcceptedDrugApplicants
2023/03/04Import · Class 2.2 Upadacitinib口服溶液 · No verified English nameJXHL2300042 AbbVie Inc.
2023/03/04Generic · Class 3 对乙酰氨基酚甘露醇注射液 · No verified English nameCYHS2300699 Jilin Kang Nai Er Pharma Co., Ltd. romanized
2023/03/04Generic · Class 3 Ketotifen Fumarate Nasal SprayCYHS2300696 Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/03/04Generic · Class 3 Aminophylline InjectionCYHS2300685 Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized
2023/03/04Generic · Class 3 Aminophylline InjectionCYHS2300684 Beijing Bai Mei Te Biopharmaceutical Co., Ltd. romanized
2023/03/04New drug · Class 1.1 健脾益肾丸 · No verified English nameCXZL2300016 Shenzhen Shi Zhong Hospital romanized
2023/03/04New drug · Class 1 BSI-060T注射液 · No verified English nameCXSL2300171 Bo Ao Xin Bio Technology (Nanjing) Co., Ltd. romanized
2023/03/04New drug · Class 1 XH101注射液 · No verified English nameCXSL2300170 Shenzhen Shi Xin He Bio Medical Technology Co., Ltd. romanized
2023/03/04New drug · Class 1 靶向BCMA-CD19的安全型嵌合抗原受体T细胞注射液 · No verified English nameCXSL2300169 Hunan Si Wei Kang Pharmaceuticals Co., Ltd. romanized
2023/03/04New drug · Class 1 9MW3911注射液 · No verified English nameCXSL2300168 Nanjing Nuo Ai Xin Bio Technology Co., Ltd. romanized
2023/03/03Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300020 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2023/03/03Import · Class 3.1 九价人乳头瘤病毒疫苗(酿酒酵母) · No verified English nameJXSS2300019 Merck Sharp & Dohme Corp. a subsidiary of Merck & Co. Inc.; MSD Ireland (Carlow); MSD R&D (China) Co. Ltd.
2023/03/03Import · Class 1 Milvexian片 · No verified English nameJXHL2300041 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/03/03Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300680 Guangzhou Wei Ao Kang Pharma Technology Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2023/03/03Generic · Class 3 Minoxidil Topical SolutionCYHS2300679 Jinan Zhong Hai Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/03/03Generic · Class 3 Minoxidil Topical SolutionCYHS2300678 Jinan Zhong Hai Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized
2023/03/03Generic · Class 3 Metoprolol Succinate Extended-release CapsulesCYHS2300677 Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized; ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD.
2023/03/03Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300675 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/03/03Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2300674 Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2023/03/03Generic · Class 3 Torsemide InjectionCYHS2300673 Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2023/03/03Generic · Class 3 Torsemide InjectionCYHS2300672 Beijing Yuan Yan Pharmaceuticals Technology Co., Ltd. romanized; Xian Han Feng Pharma Co., Ltd. romanized
2023/03/03New drug · Class 1 重组人源化抗HER2双特异性抗体注射液 · No verified English nameCXSL2300166 Shanghai Jin Man Te Bio Technology Co., Ltd. romanized
2023/03/03New drug · Class 1 BRL-186616片 · No verified English nameCXHL2300268 Xiamen Shi Bo Rui Lai Pharmaceuticals Technology Co., Ltd. romanized
2023/03/03New drug · Class 1 BRL-186616片 · No verified English nameCXHL2300267 Xiamen Shi Bo Rui Lai Pharmaceuticals Technology Co., Ltd. romanized
2023/03/03New drug · Class 2.2 注射用阿立哌唑缓释微球 · No verified English nameCXHL2300266 Hui Li Pharma (Suzhou) Co., Ltd. romanized
2023/03/03New drug · Class 2.4 注射用多西他赛(白蛋白结合型) · No verified English nameCXHL2300265 Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized
2023/03/03New drug · Class 1 WXSH0102片 · No verified English nameCXHL2300264 CISEN PHARMACEUTICAL CO., LTD.
2023/03/03New drug · Class 1 WXSH0102片 · No verified English nameCXHL2300263 CISEN PHARMACEUTICAL CO., LTD.
2023/03/03New drug · Class 2.4 奥布替尼片 · No verified English nameCXHL2300262 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized
2023/03/02Import · Class 1 RO7200220 注射液 · No verified English nameJXSL2300047 F. Hoffmann-La Roche Ltd.

44 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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