YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 368 drug applications between 27 October 2026 and 2 November 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 52, covering 38 drug names.

2026/10/27 – 2026/11/02

Period
2026/10/27 to 2026/11/02, 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
368
Drugs with new generic filings (by drug name, de-duplicated)
38
Accepted this week, now under review
368

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

368filings, 52 of them generic

By application type

Application typeFilings
Supplement195
New drug79
Generic52
Import31
Import re-registration9
Unspecified2

By drug type

Drug typeFilings
Chemical drug181
TCM110
Therapeutic biologic72
Prophylactic biologic5

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

38 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1氧 · No verified English name3315
2Vortioxetine Hydrobromide Tablets3110
3Oseltamivir Phosphate Capsules3139
4Polidocanol Injection3123
5Emedastine Difumarate Eye Drops229
6氟比洛芬凝胶贴膏 · No verified English name2216
7Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
8复方氨基酸注射液(17AA-SF) · No verified English name214
9复方电解质维持液 · No verified English name212
10帕拉米韦氯化钠注射液 · No verified English name2117

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

210 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Eli Lilly and Company910
2Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized730
3Fresenius Kabi AB720
4Hebei Wan Sui Pharma Co., Ltd. romanized660
5Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized660
6Sichuan Qi Li Pharmaceutical Co., Ltd. romanized650
7MUNDIPHARMA GmbH610
8Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized610
9AstraZeneca AB530
10Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized532

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

Entered review this week
346
Left the under-review list this week
330

Of these, NMPA published approval-document delivery for 100 (including 96 supplemental applications, not counted as new marketing approvals) and notification delivery for 5; the outcome of the other 225 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Novo Nordisk A/S152
2Shanghai Min Wei Bio Technology Co., Ltd. romanized111
3Eli Lilly Nederland B.V.82
4Xin Da Bio Technology Co., Ltd. romanized81
5Shaanxi Dong Tai Pharmaceutical Co., Ltd. romanized55
6Beijing Xian Sheng Xiang Rui Bio Zhi Pin Co., Ltd. romanized52
7Novartis Europharm Limited42
8Shanghai Xin Feng Pharmaceutical Co., Ltd. romanized42
9Jiangsu En Hua Pharma Co., Ltd. romanized42
10Sanofi-Aventis Recherche & Développement33

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Eli Lilly and Company91
2Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized73
3Fresenius Kabi AB72
4Sichuan Qi Li Pharmaceutical Co., Ltd. romanized65
5MUNDIPHARMA GmbH61
6Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized61
7AstraZeneca AB53
8Merck Europe B.V.53
9Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized51
10Bard Pharmaceuticals Limited44

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

117 this week

AcceptedDrugApplicants
2026/11/02Import · Class 1 Tilrekimig注射液 · No verified English nameJXSL2600291 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/11/02Import · Class 1 NVG-2089注射液 · No verified English nameJXSL2600290 Nuvig Therapeutics Inc.; Arcos Bio (Shanghai) Co. Ltd.
2026/11/02Generic · Class 3 碘解磷定注射液 · No verified English nameCYHS2602678 Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/11/02Generic · Class 3 Paracetamol TabletsCYHS2602673 Lu Nan Bei Te Pharmaceutical Co., Ltd. romanized
2026/11/02Generic · Class 3 Ferrous Succinate TabletsCYHS2602669 Chengdu Ke Lai Meng Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized
2026/11/02New drug · Class 3.2 注射用A型肉毒毒素 · No verified English nameCXSS2600178 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2026/11/02New drug · Class 3.2 注射用A型肉毒毒素 · No verified English nameCXSS2600177 Lanzhou Bio Technology Kai Fa Co., Ltd. romanized
2026/11/02New drug · Class 1 SHR-4610注射液 · No verified English nameCXSL2601206 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 人脐带间充质干细胞注射液 · No verified English nameCXSL2601205 Guangdong Heng Qin Joint Sheng Ming Ke Xue Co., Ltd. romanized
2026/11/02New drug · Class 1 SPGL008注射液 · No verified English nameCXSL2601204 Shenzhen Sai Bao Er Bio Pharma Co., Ltd. romanized
2026/11/02New drug · Class 2.2 SHR-8068注射液 · No verified English nameCXSL2601203 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 2.2 阿得贝利单抗注射液 · No verified English nameCXSL2601202 Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 注射用FH-006 · No verified English nameCXSL2601201 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 注射用TQB2102 · No verified English nameCXSL2601200 Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized
2026/11/02New drug · Class 2.2 贝伐珠单抗注射液 · No verified English nameCXSL2601199 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 注射用SHR-1826 · No verified English nameCXSL2601198 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 SHR-4375注射液 · No verified English nameCXSL2601197 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 注射用HS-20093 · No verified English nameCXSL2601196 Changzhou Heng Bang Pharma Co., Ltd. romanized
2026/11/02New drug · Class 1 注射用SHR-9839(sc) · No verified English nameCXSL2601195 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1.1 重组金黄色葡萄球菌疫苗(大肠杆菌) · No verified English nameCXSL2601194 Chengdu Ou Lin Bio Technology Co., Ltd. romanized; Chongqing Yuan Lun Bio Technology Co., Ltd. romanized
2026/11/02New drug · Class 1 注射用HBT-708 · No verified English nameCXSL2601193 Shenyang San Sheng Pharmaceutical Co., Ltd. romanized
2026/11/02New drug · Class 1 WTX-212C自体工程化红细胞注射液 · No verified English nameCXSL2601192 Xi Hu Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized
2026/11/02New drug · Class 1 卡维列隆氨丁三醇片 · No verified English nameCXHS2600145 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/11/02New drug · Class 1 卡维列隆氨丁三醇片 · No verified English nameCXHS2600144 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/11/02New drug · Class 1 卡维列隆氨丁三醇片 · No verified English nameCXHS2600143 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/11/02New drug · Class 1 HRS-6093片 · No verified English nameCXHL2601349 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 HRS-6093片 · No verified English nameCXHL2601348 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 HRS-7058胶囊 · No verified English nameCXHL2601347 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 HRS-7058胶囊 · No verified English nameCXHL2601346 Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/11/02New drug · Class 1 HRS-2329片 · No verified English nameCXHL2601345 Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized

87 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.