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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 264 drug applications between 13 June 2023 and 19 June 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 57, covering 43 drug names.

2023/06/13 – 2023/06/19

Period
2023/06/13 to 2023/06/19, 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
264
Drugs with new generic filings (by drug name, de-duplicated)
43
Accepted this week, now under review
2

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

264filings, 57 of them generic

By application type

Application typeFilings
Supplement133
Generic57
New drug42
Import19
Unspecified9
Import re-registration4

By drug type

Drug typeFilings
Chemical drug183
TCM47
Therapeutic biologic30
Biologic2
Prophylactic 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

43 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Acarbose Tablets323
2Ethyl Iosapentate Capsules2227
3Empagliflozin Tablets2218
4Methocarbamol Injection223
5ω-3鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name210
6Ibrutinib Tablets210
7Furosemide Injection216
8Vonoprazan Fumarate Tablets2160
9Levocarnitine Injection214
10Procaterol Hydrochloride Oral Solution2112

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

174 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Changsha Ai Bei Gao Pharma Co., Ltd. romanized660
2Janssen Research & Development LLC550
3Shanghai Huang Xiang Tie Li Lan Tian Pharmaceutical Co., Ltd. romanized550
4An Guo Ya Dong Biopharmaceutical Co., Ltd. romanized550
5Huang Shi Yan Wu Pharma Co., Ltd. romanized440
6Novartis Pharma Schweiz AG430
7Sichuan Kelun Pharmaceutical Co., Ltd.434
8Hangzhou Ji Tai Pharmaceuticals Technology Co., Ltd. romanized410
9Zhejiang Ya Tai Pharma Co., Ltd. romanized410
10Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) 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

78 this week

AcceptedDrugApplicants
2023/06/19Generic · Class 3 Ibrutinib TabletsCYHS2301654 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/06/19Generic · Class 3 Ibrutinib TabletsCYHS2301653 Qilu Pharmaceutical (Hainan) Co., Ltd
2023/06/19New drug · Class 1 人肝细胞血浆灌流器 · No verified English nameCXSL2300421 Suzhou Rui Lai Bio Technology Co., Ltd. romanized
2023/06/19New drug · Class 2.2 IBI310 · No verified English nameCXSL2300420 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2023/06/19New drug · Class 1 HSK21542片 · No verified English nameCXHL2300665 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/06/19New drug · Class 1 HSK21542片 · No verified English nameCXHL2300664 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2023/06/19New drug · Class 1 TCIC-002颗粒 · No verified English nameCXHL2300663 Tang Chuan Bio Technology (Xiamen) Co., Ltd. romanized
2023/06/19New drug · Class 1 TCIC-002颗粒 · No verified English nameCXHL2300662 Tang Chuan Bio Technology (Xiamen) Co., Ltd. romanized
2023/06/17Generic · Class 3 Proparacaine Hydrochloride Eye DropsCYHS2301650 Hefei Li Fang Pharmaceutical Co., Ltd. romanized; Zhejiang Sha Pu Ai Si Pharma Co., Ltd. romanized
2023/06/17Generic · Class 3 Oxacillin Sodium for InjectionCYHS2301647 Jiangsu Jiang Feng Pharmaceuticals Technology Co., Ltd. romanized; Shandong Rui Ying Pharmaceutical Group Co., Ltd. romanized
2023/06/17New drug · Class 1 SPH3127片 · No verified English nameCXHS2300055 Shanghai Shang Yao Xin Yi Pharmaceutical Factory Co., Ltd. romanized
2023/06/17New drug · Class 1 RAB001注射液 · No verified English nameCXHL2300661 Zhong Shan Lai Bo Rui Chen Biopharmaceuticals Co., Ltd. romanized
2023/06/17New drug · Class 1 泰普格雷片 · No verified English nameCXHL2300660 Tianjin Drug Research Institute Co., Ltd. romanized
2023/06/17New drug · Class 1 泰普格雷片 · No verified English nameCXHL2300659 Tianjin Drug Research Institute Co., Ltd. romanized
2023/06/17New drug · Class 1 泰普格雷片 · No verified English nameCXHL2300658 Tianjin Drug Research Institute Co., Ltd. romanized
2023/06/16Import · Class 1 MEDI5752 · No verified English nameJXSL2300110 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/06/16Import · Class 2.2 古塞奇尤单抗注射液 · No verified English nameJXSL2300109 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 2.3 Guselkumab/Golimumab(JNJ-78934804)注射液 · No verified English nameJXSL2300108 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 2.2 戈利木单抗注射液 · No verified English nameJXSL2300107 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/06/16Import · Class 1 LOXO-783片 · No verified English nameJXHL2300143 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/06/16Import · Class 1 LOXO-783片 · No verified English nameJXHL2300142 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2023/06/16Import · Class 1 RO7435846片 · No verified English nameJXHL2300141 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/06/16Import · Class 1 RO7435846片 · No verified English nameJXHL2300140 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2023/06/16Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301644 Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized
2023/06/16Generic · Class 3 Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2301643 Hunan Yin Ze Hua Hao Bio Technology Co., Ltd. romanized; Shuang He Pharma (Hainan) Co., Ltd. romanized
2023/06/16Generic · Class 3 Diprophylline InjectionCYHS2301642 Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized
2023/06/16Generic · Class 3 Neostigmine Methylsulfate InjectionCYHS2301639 Shanxi Zhen Dong Tai Sheng Pharmaceutical Co., Ltd. romanized
2023/06/16Generic · Class 3 Furosemide Oral SolutionCYHS2301638 Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized
2023/06/16Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2301636 Guangdong Wen Jian Pharma Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized
2023/06/16Generic · Class 3 Procaterol Hydrochloride Oral SolutionCYHS2301635 Guangdong Wen Jian Pharma Co., Ltd. romanized; Shanxi Tong Da Pharma Co., Ltd. romanized

48 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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