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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 347 drug applications between 13 March 2025 and 19 March 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 83, covering 61 drug names.

2025/03/13 – 2025/03/19

Period
2025/03/13 to 2025/03/19, 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
347
Drugs with new generic filings (by drug name, de-duplicated)
61
Accepted this week, now under review
22

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

347filings, 83 of them generic

By application type

Application typeFilings
Supplement167
Generic83
New drug57
Import22
Unspecified13
Import re-registration5

By drug type

Drug typeFilings
Chemical drug251
TCM47
Therapeutic biologic43
Prophylactic biologic4
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

61 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sacubitril Valsartan Sodium Tablets4270
2Lactulose Oral Solution3234
3Riociguat Tablets314
4腺苷钴胺胶囊 · No verified English name228
5Vonoprazan Fumarate Tablets2160
6Famotidine Injection218
7Hydrocortisone Sodium Succinate for Injection2116
8Ciclosporin Soft Capsules212
9Edoxaban Tosilate Tablets219
10Lidocaine Hydrochloride Injection216

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

200 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized880
2Nan Yang Pu Kang Heng Wang Pharma Co., Ltd. romanized770
3Hunan Jiudian Pharmaceutical Co., Ltd650
4Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized630
5Nei Menggu Fu Shou Tang Pharmaceutical Co., Ltd. romanized550
6AstraZeneca AB530
7Li Bang Pharma (Shanghai) Co., Ltd. romanized510
8Guangzhou Ze Sheng Pharma Technology Co., Ltd. romanized440
9Zhongguo Ke College Shanghai Drug Research Institute romanized430
10Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized420

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

111 this week

AcceptedDrugApplicants
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
2025/03/18Import · Class 2.4 地非法林注射液 · No verified English nameJXHL2500049 Vifor Fresenius Medical Care Renal Pharma Ltd.; Zhejiang Medical Technology Development Co. LTD.
2025/03/18Import · Class 1 VSA001注射液 · No verified English nameJXHL2500048 Arrowhead Pharmaceuticals Inc.; Sanofi (China) Investment Co. Ltd.
2025/03/18Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2501100 Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/03/18Generic · Class 3 Hydrocortisone Sodium Succinate for InjectionCYHS2501099 Henan Li Hua Pharmaceutical Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2025/03/18Generic · Class 3 Propafenone Hydrochloride InjectionCYHS2501097 Anhui Chang Jiang Pharma Co., Ltd. romanized
2025/03/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501096 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/03/18Generic · Class 3 Sodium Nitroprusside InjectionCYHS2501095 Chengdu Giantech Hi-technology Development Co., Ltd.; Sichuan Mei Da Kang Jia Le Pharma Co., Ltd. romanized
2025/03/18Generic · Class 3 Doxycycline Hyclate for InjectionCYHS2501092 Hainan Brilliant Pharmaceutical Co., Ltd.
2025/03/18Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2501090 Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/03/18Generic · Class 3 Labetalol Hydrochloride InjectionCYHS2501089 Jiu Hua Hua Yuan Pharma (Gui Lin) Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd.
2025/03/18Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2501088 Henan Pu Rui Pharma Co., Ltd. romanized
2025/03/18Generic · Class 3 Lidocaine Hydrochloride InjectionCYHS2501087 Henan Pu Rui Pharma Co., Ltd. romanized

81 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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