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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 297 drug applications between 12 April 2023 and 18 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 46 drug names.

2023/04/12 – 2023/04/18

Period
2023/04/12 to 2023/04/18, 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
297
Drugs with new generic filings (by drug name, de-duplicated)
46
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

297filings, 56 of them generic

By application type

Application typeFilings
Supplement150
Generic56
New drug52
Import20
Import re-registration11
Unspecified7
Drug-device combination product1

By drug type

Drug typeFilings
Chemical drug203
TCM56
Therapeutic biologic33
Biologic2
Prophylactic biologic2
Drug-device combination1

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

46 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diprophylline Injection337
2Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
3Irbesartan and Amlodipine Tablets211
4咪达唑仑口服溶液 · No verified English name210
5Lacosamide Injection210
6Nicorandil for Injection211
7Bupivacaine Hydrochloride Injection214
8Lurasidone Hydrochloride Tablets212
9Azilsartan Medoxomil Potassium Tablets2135
10Sodium Valproate Sustained-release Tablets(I)114

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

169 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized23230
2Changsha Ai Bei Gao Pharma Co., Ltd. romanized12120
3Sichuan Kelun Pharmaceutical Co., Ltd.642
4Hainan Heng Cheng San Ye Pharmaceutical Co., Ltd. romanized640
5McNeil Sweden AB610
6Janssen Research & Development LLC520
7Eli Lilly and Company510
8Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized510
9Henan Lan Tian Pharma Co., Ltd. romanized440
10CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD430

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

95 this week

AcceptedDrugApplicants
2023/04/18Import · Class 2.3 尼拉帕利醋酸阿比特龙片 · No verified English nameJXHS2300035 Janssen-Cilag International NV; PATHEON FRANCE; Xian Janssen Pharmaceutical Ltd.
2023/04/18Import · Class 2.3 尼拉帕利醋酸阿比特龙片 · No verified English nameJXHS2300034 Janssen-Cilag International NV; PATHEON FRANCE; Xian Janssen Pharmaceutical Ltd.
2023/04/18Import · Class 1 BAY 1747846 注射液 · No verified English nameJXHL2300087 Bayer AG; Bayer Healthcare Company Ltd.
2023/04/18Import · Class 1 BAY 1747846 注射液 · No verified English nameJXHL2300086 Bayer AG; Bayer Healthcare Company Ltd.
2023/04/18Import · Class 1 BAY 1747846 注射液 · No verified English nameJXHL2300085 Bayer AG; Bayer Healthcare Company Ltd.
2023/04/18Generic · Class 3 Mepivacaine Hydrochloride InjectionCYHS2301073 Jinan Kang Qiao Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2023/04/18Generic · Class 3 Baclofen Oral SolutionCYHS2301070 Jiangsu Tian Shi Li Di Yi Pharma Co., Ltd. romanized; Nanjing Hai Na Pharmaceutical Co., Ltd. romanized
2023/04/18Generic · Class 3 Diquafosol Sodium Eye DropsCYHL2300055 Can Tian Pharmaceutical (Zhongguo) Co., Ltd. romanized
2023/04/18New drug · Class 1.1 养阴舒肝颗粒 · No verified English nameCXZL2300027 Guangzhou Pharmaceuticals Research Zong Yuan Co., Ltd. romanized
2023/04/18New drug · Class 1 CF04滴眼液 · No verified English nameCXSL2300270 Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized
2023/04/18New drug · Class 1 CF04滴眼液 · No verified English nameCXSL2300269 Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized
2023/04/18New drug · Class 1 CF04滴眼液 · No verified English nameCXSL2300268 Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized
2023/04/18New drug · Class 1 CF04滴眼液 · No verified English nameCXSL2300267 Shanghai Pu You Biopharmaceuticals Co., Ltd. romanized
2023/04/18New drug · Class 1 KN056注射液 · No verified English nameCXSL2300266 Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized
2023/04/18New drug · Class 3.3 重组抗CTLA-4全人单克隆抗体注射液 · No verified English nameCXSL2300265 Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized
2023/04/18New drug · Class 1 注射用SHR-A1811 · No verified English nameCXSL2300264 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2023/04/18New drug · Class 2.2 LJ01003 · No verified English nameCXHS2300046 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2023/04/18New drug · Class 2.2 LJ01003 · No verified English nameCXHS2300045 Changchun Lan Jiang Pharmaceuticals Technology Co., Ltd. romanized; Zhi En Bio Technology Co., Ltd. romanized
2023/04/18New drug · Class 2.4 Fruquintinib CapsulesCXHS2300044 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized
2023/04/18New drug · Class 2.4 Fruquintinib CapsulesCXHS2300043 He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized; He Ji Huang Pu Pharmaceuticals (Suzhou) Co., Ltd. romanized
2023/04/18New drug · Class 2.4 Pyrotinib Maleate TabletsCXHL2300389 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/18New drug · Class 2.4 Pyrotinib Maleate TabletsCXHL2300388 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/18New drug · Class 1 TQ05105片 · No verified English nameCXHL2300387 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/04/18New drug · Class 1 TQB3617胶囊 · No verified English nameCXHL2300386 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/04/18New drug · Class 1 TQB3617胶囊 · No verified English nameCXHL2300385 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2023/04/18New drug · Class 1 CS23546片 · No verified English nameCXHL2300384 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2023/04/18New drug · Class 1 CS23546片 · No verified English nameCXHL2300383 Shenzhen Wei Xin Bio Technology Co., Ltd. romanized
2023/04/17Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2301068 Anhui Xin Shi Ji Pharma Co., Ltd. romanized
2023/04/17Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301066 Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2023/04/17Generic · Class 3 Proparacaine Hydrochloride Eye DropsCYHS2301065 Hefei Li Fang Pharmaceutical Co., Ltd. romanized; Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized

65 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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