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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 287 drug applications between 11 April 2023 and 17 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 51, covering 40 drug names.

2023/04/11 – 2023/04/17

Period
2023/04/11 to 2023/04/17, 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
287
Drugs with new generic filings (by drug name, de-duplicated)
40
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

287filings, 51 of them generic

By application type

Application typeFilings
Supplement156
Generic51
New drug40
Import18
Import re-registration15
Unspecified7

By drug type

Drug typeFilings
Chemical drug212
TCM37
Therapeutic biologic34
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

40 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Diprophylline Injection337
2Acetylcysteine Solution For Inhalation224
3Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution2223
4Irbesartan and Amlodipine Tablets211
5咪达唑仑口服溶液 · No verified English name210
6Nicorandil for Injection211
7Bupivacaine Hydrochloride Injection214
8盐酸特比萘芬喷雾剂 · No verified English name217
9Lurasidone Hydrochloride Tablets212
10Azilsartan Medoxomil Potassium Tablets2135

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

154 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Heng Cheng San Ye Pharmaceutical Co., Ltd. romanized36310
2Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized14140
3Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized771
4McNeil Sweden AB610
5Janssen Research & Development LLC520
6Eli Lilly and Company510
7Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized510
8Henan Lan Tian Pharma Co., Ltd. romanized440
9Novartis Pharma Schweiz AG420
10Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized410

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
2023/04/17Generic · 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
2023/04/17Generic · Class 3 Nicergoline TabletsCYHS2301063 Beijing Foyou Pharma CO.,LTD
2023/04/17New drug · Class 3.1 桃红四物汤颗粒 · No verified English nameCXZS2300009 Rui Yang Pharmaceutical Co., Ltd. romanized
2023/04/17New drug · Class 1 BAT1308注射液 · No verified English nameCXSL2300263 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2023/04/17New drug · Class 1 HBW-3220胶囊 · No verified English nameCXHL2300382 Chengdu Hai Bo Wei Pharma Co., Ltd. romanized
2023/04/17New drug · Class 1 注射用MT1002 · No verified English nameCXHL2300381 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2023/04/17New drug · Class 1 注射用MT1002 · No verified English nameCXHL2300380 Shaanxi Mai Ke Ao Te Technology Co., Ltd. romanized
2023/04/17New drug · Class 1 WD-890片 · No verified English nameCXHL2300379 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2023/04/17New drug · Class 1 WD-890片 · No verified English nameCXHL2300378 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2023/04/17New drug · Class 1 WD-890片 · No verified English nameCXHL2300377 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2023/04/17New drug · Class 1 WD-890片 · No verified English nameCXHL2300376 Zhejiang Wen Da Pharmaceuticals Technology Co., Ltd. romanized
2023/04/17New drug · Class 1 CPU-118片 · No verified English nameCXHL2300375 Nanjing Qin Ling Pharmaceuticals Technology Co., Ltd. romanized
2023/04/15Import · Class 1 Monalizumab 注射液 · No verified English nameJXSL2300068 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2023/04/15Generic · Class 3 Chlorphenamine Maleate InjectionCYHS2301060 Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/04/15Generic · Class 3 Diprophylline InjectionCYHS2301059 Nanjing Kang Fa Bio Technology Co., Ltd. romanized; Jin Ling Pharma Co., Ltd. Nanjing Jin Ling Pharmaceutical Factory romanized
2023/04/15Generic · Class 3 Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2301056 Jewim Pharmaceutical (Shandong) Co., Ltd.
2023/04/15New drug · Class 2.2 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2300262 Zhong Yi An Ke Bio Technology Co., Ltd. romanized; Liaoning Mao Kang Yuan Bio Technology Co., Ltd. romanized
2023/04/15New drug · Class 1 RC198注射液 · No verified English nameCXSL2300261 Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized
2023/04/15New drug · Class 1 HS-10365胶囊 · No verified English nameCXHL2300374 Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized
2023/04/15New drug · Class 1 HEC53856片 · No verified English nameCXHL2300373 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/04/15New drug · Class 1 HEC53856片 · No verified English nameCXHL2300372 Guangdong Dong Yang Guang Pharma Co., Ltd. romanized
2023/04/14Import · Class 1 LY3437943注射液 · No verified English nameJXHL2300084 Eli Lilly and Company
2023/04/14Import · Class 1 LY3437943注射液 · No verified English nameJXHL2300083 Eli Lilly and Company
2023/04/14Import · Class 1 LY3437943注射液 · No verified English nameJXHL2300082 Eli Lilly and Company
2023/04/14Import · Class 1 LY3437943注射液 · No verified English nameJXHL2300081 Eli Lilly and Company
2023/04/14Import · Class 1 LY3437943注射液 · No verified English nameJXHL2300080 Eli Lilly and Company
2023/04/14Generic · Class 3 Isoniazid InjectionCYHS2301054 Jia Shi (Hunan) Pharmaceuticals Technology Co., Ltd. romanized; Hunan Wu Zhou Tong Pharma Co., Ltd. romanized
2023/04/14Generic · Class 3 Entecavir oral solutionCYHS2301053 Guizhou Fu Kang Ren Pharmaceutical Co., Ltd. romanized; Hubei Wei Sen Pharmaceutical 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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