YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 310 drug applications between 17 March 2026 and 23 March 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 34, covering 29 drug names.

2026/03/17 – 2026/03/23

Period
2026/03/17 to 2026/03/23, 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
310
Drugs with new generic filings (by drug name, de-duplicated)
29
Accepted this week, now under review
64

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

310filings, 34 of them generic

By application type

Application typeFilings
Supplement203
New drug45
Generic34
Import16
Unspecified7
Import re-registration5

By drug type

Drug typeFilings
Chemical drug167
TCM113
Therapeutic biologic25
Biologic4
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

29 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Levofloxacin Eye Drops3116
2Isosorbide Mononitrate Extended-Release Tablets215
3Selexipag Tablets2124
4Lacidipine Tablets217
5二硫化硒洗剂 · No verified English name1114
6伏硫西汀滴剂 · No verified English name111
7依非米替片(I) · No verified English name112
8Lidocaine Cataplasms117
9头孢克肟干混悬剂 · No verified English name113
10Ketotifen Fumarate Oral Solution118

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

178 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized910
2Jin Zhou Fu Shou Tang Pharmaceuticals Technology Co., Ltd. romanized880
3Shaanxi Pan Long Pharma Group Co., Ltd. romanized880
4HARBIN MEDISAN PHARMACEUTICAL CO.,LTD.710
5Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized650
6Nei Menggu Ku Lun Meng Yao Co., Ltd. romanized550
7Qilu Pharmaceutical Co., Ltd.540
8Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized530
9Amgen Inc.520
10Nanjing Tong Ren Tang Pharma 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

70 this week

AcceptedDrugApplicants
2026/03/23Import · Class 2.4 那米司特片 · No verified English nameJXHL2600090 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Import · Class 2.4 那米司特片 · No verified English nameJXHL2600089 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Import · Class 2.4 那米司特片 · No verified English nameJXHL2600088 Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd.
2026/03/23Generic · Class 3 头孢克肟干混悬剂 · No verified English nameCYHS2600697 Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Jin Hong Pharma Co., Ltd. romanized
2026/03/23Generic · Class 3 硫酸特布他林口服溶液 · No verified English nameCYHS2600696 Suzhou Hong Sen Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂 · No verified English nameCXHL2600361 Jiangsu De Mai Pharma Co., Ltd. romanized
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂 · No verified English nameCXHL2600360 Jiangsu De Mai Pharma Co., Ltd. romanized
2026/03/23New drug · Class 2.2 DMI019鼻喷雾剂 · No verified English nameCXHL2600359 Jiangsu De Mai Pharma Co., Ltd. romanized
2026/03/21Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600084 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2026/03/21Import · Class 2.1 注射用贝林妥欧单抗(皮下注射) · No verified English nameJXSL2600083 Amgen Inc.; BeOne Medicines (Beijing) Co. Ltd.
2026/03/21Import · Class 1 MK-1084片 · No verified English nameJXHL2600087 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/03/21Import · Class 1 MK-1084片 · No verified English nameJXHL2600086 Merck Sharp & Dohme LLC; MSD R&D (China) Co. Ltd
2026/03/21New drug · Class 2.2 夫那奇珠单抗注射液 · No verified English nameCXSL2600342 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 2.2 夫那奇珠单抗注射液 · No verified English nameCXSL2600341 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 2.2 夫那奇珠单抗注射液 · No verified English nameCXSL2600340 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 1 SHR-6914注射液 · No verified English nameCXSL2600339 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 1 HP-002片 · No verified English nameCXHL2600356 Shanghai Chao Yang Pharma Co., Ltd. romanized
2026/03/21New drug · Class 1 HP-002片 · No verified English nameCXHL2600355 Shanghai Chao Yang Pharma Co., Ltd. romanized
2026/03/21New drug · Class 1 HP-002片 · No verified English nameCXHL2600354 Shanghai Chao Yang Pharma Co., Ltd. romanized
2026/03/21New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600353 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600352 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600351 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600350 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600349 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/21New drug · Class 1 HRS9531注射液 · No verified English nameCXHL2600348 Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/03/20Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2600032 AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.
2026/03/20Import · Class 2.4 Upadacitinib Sustained-release TabletsJXHS2600031 AbbVie Deutschland GmbH & Co. KG; AbbVie Ireland NL B.V.
2026/03/20Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2600687 Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized
2026/03/20New drug · Class 2.1 YK-2001注射液 · No verified English nameCXHS2600044 Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized; Nanjing You Ke Pharmaceutical Co., Ltd. romanized
2026/03/20New drug · Class 2.1 YK-2001注射液 · No verified English nameCXHS2600043 Nanjing Li Bo Wei Pharmaceutical Co., Ltd. romanized; Nanjing You Ke Pharmaceutical Co., Ltd. romanized

40 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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