YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 418 drug applications between 5 September 2025 and 11 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 114, covering 78 drug names.

2025/09/05 – 2025/09/11

Period
2025/09/05 to 2025/09/11, 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
418
Drugs with new generic filings (by drug name, de-duplicated)
78
Accepted this week, now under review
120

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

418filings, 114 of them generic

By application type

Application typeFilings
Supplement178
Generic114
New drug79
Import34
Unspecified9
Import re-registration4

By drug type

Drug typeFilings
Chemical drug265
TCM74
Therapeutic biologic73
Biologic5
Prophylactic biologic1

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

78 drugs with new generic filings; top 10 listed

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

250 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company1440
2Fuzhou Hai Wang Jin Xiang Zhong Yao Pharmaceutical Co., Ltd. romanized860
3Qilu Pharmaceutical Co., Ltd.840
4Topfond Pharmaceutical Co., Ltd.770
5Pfizer Inc.730
6Janssen Research & Development LLC710
7AstraZeneca AB630
8Shanghai Shi Ling Pharmaceutical Co., Ltd. romanized610
9Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized440
10Ren He Yi Kang Hui Ze Pharma Hebei 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

156 this week

AcceptedDrugApplicants
2025/09/11Import · Class 1 Insulin efsitora alfa 注射液 · No verified English nameJXSS2500123 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/11Import · Class 2.4 BMS-986165片 · No verified English nameJXHL2500283 Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd.
2025/09/11Generic · Class 3 拉考沙胺颗粒 · No verified English nameCYHS2503370 Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd.
2025/09/11Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2503369 Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Guo Jing Pharma Co., Ltd. romanized
2025/09/11Generic · Class 3 Lidocaine Hydrochloride Ophthalmic GelCYHS2503367 Shanghai Hao Hai Bio Technology Co., Ltd. romanized
2025/09/11Generic · Class 3 Loxoprofen Sodium Oral SolutionCYHS2503366 Hunan Ou La Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Zhong Sheng Pharma Co., Ltd. romanized
2025/09/11Generic · Class 3 替比培南匹伏酯颗粒 · No verified English nameCYHL2500165 Shandong Lukang Pharmaceutical Co.,Ltd.
2025/09/11New drug · Class 1 泰利奇拜单抗注射液 · No verified English nameCXSS2500092 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/09/11New drug · Class 1 泰利奇拜单抗注射液 · No verified English nameCXSS2500091 Chongqing Zhi Xiang Jin Tai Biopharmaceutical Co., Ltd. romanized
2025/09/11New drug · Class 3.3 帕博利珠单抗注射液 · No verified English nameCXSL2500787 Shanghai Hong Cheng Pharma Co., Ltd. romanized
2025/09/11New drug · Class 1 注射用HS-20110 · No verified English nameCXSL2500786 Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized; Changzhou Heng Bang Pharma Co., Ltd. romanized
2025/09/11New drug · Class 1 注射用JS207 · No verified English nameCXSL2500785 Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized
2025/09/11New drug · Class 1 HRS-1780 片 · No verified English nameCXHL2500993 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/11New drug · Class 1 HRS-1780 片 · No verified English nameCXHL2500992 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2025/09/11New drug · Class 2.2; 2.4 ZYG24002 · No verified English nameCXHL2500991 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2025/09/11New drug · Class 2.2; 2.4 ZYG24002 · No verified English nameCXHL2500990 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2025/09/11New drug · Class 2.2; 2.4 ZYG24002 · No verified English nameCXHL2500989 Jiangsu Ziyond Pharmaceutical Co., Ltd.
2025/09/10Import · Class 1 Empasiprubart注射用浓溶液 · No verified English nameJXSL2500173 argenx BV; PPD Pharmaceutical Development(Beijing)Co.,Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500275 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500274 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500273 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500272 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500271 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 2.4 替尔泊肽注射液 · No verified English nameJXHL2500270 Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd.
2025/09/10Import · Class 1 PF-07799933片 · No verified English nameJXHL2500269 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Import · Class 1 PF-07799933片 · No verified English nameJXHL2500268 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Import · Class 1 PF-07799544片 · No verified English nameJXHL2500267 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Import · Class 1 PF-07799544片 · No verified English nameJXHL2500266 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Import · Class 1 PF-07799544片 · No verified English nameJXHL2500265 Pfizer Inc.; Pfizer (China) Research and Development Co. Ltd.
2025/09/10Generic · Class 3 生理氯化钠溶液 · No verified English nameCYHS2503357 HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.

126 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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