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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 333 drug applications between 7 April 2023 and 13 April 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 68, covering 51 drug names.

2023/04/07 – 2023/04/13

Period
2023/04/07 to 2023/04/13, 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
333
Drugs with new generic filings (by drug name, de-duplicated)
51
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

333filings, 68 of them generic

By application type

Application typeFilings
Supplement192
Generic68
New drug39
Import re-registration14
Import12
Unspecified8

By drug type

Drug typeFilings
Chemical drug254
Therapeutic biologic47
TCM29
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

51 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets515
2Diprophylline Injection337
3Everolimus Tablets212
4Irbesartan and Amlodipine Tablets211
5咪达唑仑口服溶液 · No verified English name210
6Ibuprofen Injection218
7Torsemide Injection211
8Nicorandil for Injection211
9Phenylephrine Hydrochloride Injection215
10盐酸左沙丁胺醇雾化吸入溶液 · No verified English name212

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

177 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hainan Heng Cheng San Ye Pharmaceutical Co., Ltd. romanized41360
2Janssen Research & Development LLC740
3Luye Pharma Limited710
4Jiangxi Ren Qi Pharmaceutical Co., Ltd. romanized660
5McNeil Sweden AB610
6Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized520
7Organon Pharma (UK) Limited510
8Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized515
9Beijing Han Mei Medicines Co., Ltd. romanized443
10Qilu Pharmaceutical Co., Ltd.420

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

89 this week

AcceptedDrugApplicants
2023/04/13Import · Class 3.1 地舒单抗注射液 · No verified English nameJXSS2300031 Amgen Europe B.V.; Amgen Manufacturing Limited; Amgen Biotechnology Consultation (Shanghai) Co. Ltd.
2023/04/13Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300079 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/04/13Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300078 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/04/13Import · Class 2.2 ASKC200搽剂 · No verified English nameJXHL2300077 Propella Therapeutics Inc.; Jiangsu Aosaikang Pharmaceutical Co. LTD
2023/04/13Generic · Class 3 盐酸西替利嗪滴眼液 · No verified English nameCYHS2301045 Suzhou Ou Kang Wei Shi Bio Technology Co., Ltd. romanized
2023/04/13Generic · Class 3 Diclofenac Sodium InjectionCYHS2301043 Beijing Shi Qiao Biopharmaceutical Co., Ltd. romanized
2023/04/13Generic · Class 3 Diprophylline InjectionCYHS2301042 Nanjing Heng Dao Pharmaceuticals Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized
2023/04/13Generic · Class 3 Diprophylline InjectionCYHS2301041 Nanjing Feng Kai Si Drug Research and Development Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized
2023/04/13Generic · Class 3 Irbesartan and Amlodipine TabletsCYHL2300054 Beijing Bai Ao Pharma Co., Ltd. romanized
2023/04/13Generic · Class 3 Irbesartan and Amlodipine TabletsCYHL2300053 Beijing Bai Ao Pharma Co., Ltd. romanized
2023/04/13New drug · Class 1 HH-012注射液 · No verified English nameCXSL2300256 Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized
2023/04/13New drug · Class 1 注射用JYB1907 · No verified English nameCXSL2300255 Shanghai Ji Yu Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ji Ye Biopharmaceutical Co., Ltd. romanized
2023/04/13New drug · Class 1 SPH4336片 · No verified English nameCXHL2300364 Shanghai Pharmaceuticals Group Co., Ltd. romanized
2023/04/12Import · Class 2.2 Isatuximab注射液 · No verified English nameJXSL2300067 Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd.
2023/04/12Import · Class 2.2 Teclistamab 注射液 · No verified English nameJXSL2300066 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/04/12Import · Class 2.2 Teclistamab 注射液 · No verified English nameJXSL2300065 Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd.
2023/04/12Generic · Class 3 咪达唑仑口服溶液 · No verified English nameCYHS2301040 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2023/04/12Generic · Class 3 咪达唑仑口服溶液 · No verified English nameCYHS2301039 Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized
2023/04/12Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2301038 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized
2023/04/12Generic · Class 3 Nicorandil for InjectionCYHS2301036 Tian Da Pharma (Yunnan) Co., Ltd. romanized
2023/04/12Generic · Class 3 Nicorandil for InjectionCYHS2301035 Tian Da Pharma (Yunnan) Co., Ltd. romanized
2023/04/12Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2301027 Jiangxi He Ying Pharma Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2023/04/12Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2301026 Jiangxi He Ying Pharma Co., Ltd. romanized; Jiangxi Yin Tao Pharma Co., Ltd. romanized
2023/04/12New drug · Class 1 SHR-1703注射液 · No verified English nameCXSL2300253 Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized
2023/04/12New drug · Class 3.2 ACYW135 群脑膜炎球菌多糖结合疫苗(CRM197 载体) · No verified English nameCXSL2300252 Kang Xi Nuo Bio Shareholding Company romanized
2023/04/12New drug · Class 1 注射用ZB001 · No verified English nameCXSL2300251 Shanghai Ze Na Shi Bio Technology Co., Ltd. romanized
2023/04/12New drug · Class 1 IBI346 · No verified English nameCXSL2300250 Xin Da Xi Bao Pharmaceutical (Suzhou) Co., Ltd. romanized
2023/04/12New drug · Class 2.4 Neratinib Maleate TabletsCXHL2300363 Fu Kang (Shanghai) Health Technology Co., Ltd. romanized
2023/04/12New drug · Class 1 AHB-137注射液 · No verified English nameCXHL2300362 Hangzhou Hao Bo Pharmaceuticals Co., Ltd. romanized
2023/04/11Import · Class 2.2 法瑞西单抗注射液 · No verified English nameJXSS2300030 Roche Pharma (Schweiz) AG; F. Hoffmann-La Roche AG

59 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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