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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 349 drug applications between 14 March 2025 and 20 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 84, covering 62 drug names.

2025/03/14 – 2025/03/20

Period
2025/03/14 to 2025/03/20, 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
349
Drugs with new generic filings (by drug name, de-duplicated)
62
Accepted this week, now under review
26

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

349filings, 84 of them generic

By application type

Application typeFilings
Supplement179
Generic84
New drug51
Import15
Unspecified14
Import re-registration6

By drug type

Drug typeFilings
Chemical drug245
TCM52
Therapeutic biologic45
Prophylactic biologic5
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

62 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Lactulose Oral Solution3234
2Riociguat Tablets314
3氧(气态) · No verified English name221
4腺苷钴胺胶囊 · No verified English name228
5Vonoprazan Fumarate Tablets2160
6Sacubitril Valsartan Sodium Tablets2170
7Famotidine Injection218
8Hydrocortisone Sodium Succinate for Injection2116
9Loxoprofen Sodium Patches2130
10Ciclosporin Soft Capsules212

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

199 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized880
2Roche Pharma (Schweiz) AG810
3Hunan Jiudian Pharmaceutical Co., Ltd650
4Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized630
5Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized550
6AstraZeneca AB530
7Henan Pu Rui Pharma Co., Ltd. romanized535
8Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized520
9Li Bang Pharma (Shanghai) Co., Ltd. romanized510
10Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized440

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

101 this week

AcceptedDrugApplicants
2025/03/20Generic · Class 3 维生素B?注射液 · No verified English nameThe loaded source record contains a question mark in this drug name; the original character has not been verified.CYHS2501128 Hainan Quan Xing Pharmaceutical Co., Ltd. romanized
2025/03/20Generic · Class 3 Metoclopramide Hydrochloride InjectionCYHS2501127 Hubei Tian Sheng Pharma Co., Ltd. romanized
2025/03/20Generic · Class 3 Sodium Iodide[131I] Oral SolutionCYHS2501125 Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized
2025/03/20Generic · Class 3 Furosemide InjectionCYHS2501124 Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized
2025/03/20Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2501120 Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized
2025/03/20Generic · Class 3 福多司坦片 · No verified English nameCYHS2501117 Yuan Da Pharmaceuticals (Hubei) Co., Ltd. romanized; Yuan Da Pharmaceuticals (Xian Tao) Pharmaceutical Co., Ltd. romanized
2025/03/20Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2501116 Henan Pu Rui Pharma Co., Ltd. romanized
2025/03/20Generic · Class 3 Bupivacaine Hydrochloride InjectionCYHS2501115 Henan Pu Rui Pharma Co., Ltd. romanized
2025/03/20Generic · Class 3 Bromhexine Hydrochloride InjectionCYHS2501114 Duo Duo Pharma Co., Ltd. romanized
2025/03/20Generic · Class 3 Elagolix Sodium TabletsCYHL2500063 Dong Guan Song Shan Hu Mei Jian Bio Technology Co., Ltd. romanized
2025/03/20Generic · Class 3 Elagolix Sodium TabletsCYHL2500062 Dong Guan Song Shan Hu Mei Jian Bio Technology Co., Ltd. romanized
2025/03/20New drug · Class 1.1 天苓止眩片 · No verified English nameCXZL2500019 Hunan Zhong Pharmaceuticals University romanized
2025/03/19Generic · Class 3 维生素B6注射液 · No verified English nameCYHS2501112 Shanghai He Feng Pharmaceutical Co., Ltd. romanized
2025/03/19Generic · Class 3 酒石酸阿福特罗吸入溶液 · No verified English nameCYHS2501111 CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD
2025/03/19Generic · Class 3 Bromhexine Hydrochloride Oral SolutionCYHS2501110 Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized
2025/03/19Generic · Class 3 Phloroglucinol Orally Disintegrating TabletsCYHS2501105 Sichuan Hai Meng Zhi Sen Biopharmaceutical Co., Ltd. romanized; Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized
2025/03/19Generic · Class 3 左羟丙哌嗪口服溶液 · No verified English nameCYHS2501104 Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized
2025/03/19Generic · Class 3 Gatifloxacin Eye DropsCYHS2501102 Hefei Nuo Rui Te Pharmaceutical Co., Ltd. romanized; Anhui Sheng Shuang Ke Pharma Co., Ltd. romanized
2025/03/19New drug · Class 2.3 松龄血脉康胶囊 · No verified English nameCXZL2500018 Chengdu Kang Hong Pharmaceutical Co., Ltd. romanized
2025/03/19New drug · Class 1 SSS55注射液 · No verified English nameCXSL2500235 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2025/03/19New drug · Class 1 VPD/FC01002 注射液 · No verified English nameCXSL2500234 Wei Neng Sheng Ming Technology Group Co., Ltd. romanized
2025/03/19New drug · Class 1 GB18注射液 · No verified English nameCXSL2500226 Shenzhen Ke Xing Pharma Co., Ltd. romanized
2025/03/19New drug · Class 2.4 Regadenoson InjectionCXHS2500024 Nanjing Rui Ke Wei Biopharmaceuticals Co., Ltd. romanized; Nanjing Hai Rong Pharmaceutical Co., Ltd. romanized
2025/03/19New drug · Class 2.1; 2.2; 2.4 醋酸沃诺拉赞注射液 · No verified English nameCXHS2500023 Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized; Nanjing Ke Fei Ping Sheng Hui Pharmaceutical Co., Ltd. romanized
2025/03/19New drug · Class 1 AP303片 · No verified English nameCXHL2500306 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2025/03/19New drug · Class 1 AP303片 · No verified English nameCXHL2500305 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2025/03/19New drug · Class 1 AP303片 · No verified English nameCXHL2500304 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2025/03/19New drug · Class 1 AP303片 · No verified English nameCXHL2500303 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2025/03/19New drug · Class 1 AP303片 · No verified English nameCXHL2500302 Li Bang Pharma (Shanghai) Co., Ltd. romanized
2025/03/19New drug · Class 2.2 NS1009 · No verified English nameCXHL2500301 Xin Ling Pharmaceuticals (Zhong Shan) Co., Ltd. romanized

71 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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