YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 291 drug applications between 25 January 2024 and 31 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 87, covering 65 drug names.

2024/01/25 – 2024/01/31

Period
2024/01/25 to 2024/01/31, 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
291
Drugs with new generic filings (by drug name, de-duplicated)
65
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

291filings, 87 of them generic

By application type

Application typeFilings
Supplement121
Generic87
New drug51
Import re-registration15
Import13
Unspecified4

By drug type

Drug typeFilings
Chemical drug197
TCM46
Therapeutic biologic34
Prophylactic biologic11
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

65 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Minoxidil Liniment5152
2Riociguat Tablets314
3Peramivir Injection227
4Bisoprolol Fumarate and Amlodipine Besylate Tablets229
5Nintedanib Esilate Soft Capsules216
6Tadalafil Tablets2123
7Betamethasone Sodium Phosphate Injection215
8Risperidone Orally Disintegrating Tablets210
9Diquafosol Sodium Eye Drops215
10Vonoprazan Fumarate Tablets2160

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

189 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Hubei Fu Ren Jin Shen Pharma Co., Ltd. romanized770
2Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized747
3Pfizer Inc.730
4Sanofi -aventis France710
5Le Fu Si Health Industry Shareholding Company romanized515
6Xizang An Xing Pharmaceuticals Co., Ltd. romanized420
7Merck Sharp & Dohme LLC410
8Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized410
9Novo Nordisk A/S330
10Jilin Sheng Zhang Yuan Pharma Co., Ltd. romanized330

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

96 this week

AcceptedDrugApplicants
2024/01/31Import · Class 3.1 Elranatamab注射液 · No verified English nameJXSS2400006 Pfizer Inc.; Pharmacia & Upjohn Company LLC; Pfizer Investment Co. Ltd.
2024/01/31Import · Class 3.1 Elranatamab注射液 · No verified English nameJXSS2400005 Pfizer Inc.; Pharmacia & Upjohn Company LLC; Pfizer Investment Co. Ltd.
2024/01/31Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400026 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/01/31Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400025 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/01/31Import · Class 1 Ulixacaltamide缓释片 · No verified English nameJXHL2400024 Praxis Precision Medicines; Tenacia Biotechnology (Shanghai) Co. Ltd
2024/01/31Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2400417 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/01/31Generic · Class 3 Sodium Cromoglicate Eye DropsCYHS2400416 Zhongshan Wanhan Pharmaceuticals Co., Ltd.
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400414 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400413 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400412 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400411 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Minoxidil LinimentCYHS2400410 Le Fu Si Health Industry Shareholding Company romanized; Guangdong Ke Lun Pharma Co., Ltd. romanized
2024/01/31Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2400406 Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/01/31Generic · Class 3 Proparacaine Hydrochloride Eye DropsCYHS2400405 Zhao Ke (Guangzhou) Yan Ke Drug Co., Ltd. romanized
2024/01/31Generic · Class 3 Phenylephrine Hydrochloride InjectionCYHS2400404 Zhuhai Qian Lie Pharma Co., Ltd. romanized; HUNAN WARRANT PHARMACEUTICAL CO.,LTD
2024/01/31Generic · Class 3 Piracetam InjectionCYHS2400403 Xian Da Mo Pharmaceutical Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized
2024/01/31Generic · Class 3 Peramivir InjectionCYHS2400400 Shandong Qidu Pharmaceutical Co., Ltd.
2024/01/31New drug · Class 1 TQB2928注射液 · No verified English nameCXSL2400080 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2024/01/31New drug · Class 1 KSH01注射液 · No verified English nameCXSL2400079 Ke Shi Hua (Shenzhen) Bio Technology Co., Ltd. romanized; Ke Shi Hua (Nanjing) Bio Technology Co., Ltd. romanized
2024/01/31New drug · Class 1 γδ-T细胞注射液 · No verified English nameCXSL2400078 Guangdong Ji De Kang Min Bio Technology Co., Ltd. romanized
2024/01/31New drug · Class 1 输注用SN-001浓缩冻干粉 · No verified English nameCXSL2400077 Kunming Sai Nuo Pharmaceutical Co., Ltd. romanized
2024/01/31New drug · Class 1 靶向GPC3装甲型嵌合抗原受体自体T细胞注射液C-CAR031 · No verified English nameCXSL2400076 Shanghai Sai Bi Man Bio Technology Co., Ltd. romanized
2024/01/31New drug · Class 1.1 六价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2400075 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2024/01/31New drug · Class 1.1 六价重组诺如病毒疫苗(汉逊酵母) · No verified English nameCXSL2400074 Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized
2024/01/31New drug · Class 1 KYS202003A注射液 · No verified English nameCXSL2400073 Jiangsu Kang Yuan Pharma Co., Ltd. romanized
2024/01/31New drug · Class 3.4 人凝血因子IX · No verified English nameCXSL2400072 Chengdu Rong Sheng Pharma Co., Ltd. romanized
2024/01/31New drug · Class 1 BAT4406F注射液 · No verified English nameCXSL2400071 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/01/31New drug · Class 2.4 注射用BAT4306F · No verified English nameCXSL2400070 Bai Ao Tai Biopharmaceutical Co., Ltd. romanized
2024/01/31New drug · Class 1 HSK31858片 · No verified English nameCXHL2400125 Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized
2024/01/31New drug · Class 1 注射用HYH2006078P1 · No verified English nameCXHL2400124 Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized

66 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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.