YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 382 drug applications between 23 October 2026 and 29 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 60, covering 42 drug names.

2026/10/23 – 2026/10/29

Period
2026/10/23 to 2026/10/29, 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
382
Drugs with new generic filings (by drug name, de-duplicated)
42
Accepted this week, now under review
375

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

382filings, 60 of them generic

By application type

Application typeFilings
Supplement226
Generic60
New drug53
Import34
Import re-registration6
Unspecified3

By drug type

Drug typeFilings
Chemical drug175
TCM115
Therapeutic biologic82
Biologic5
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

42 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ruxolitinib Phosphate Tablets4227
2Vortioxetine Hydrobromide Tablets3110
3Oseltamivir Phosphate Capsules3139
4Polidocanol Injection3123
5Suvorexant Tablets313
6氟比洛芬凝胶贴膏 · No verified English name2216
7Ezetimibe and Atorvastatin Calcium Trihydrate Tablets214
8复方电解质维持液 · No verified English name212
9Sodium Hyaluronate Eye Drops2130
10苯磺酸美洛加巴林口崩片 · No verified English name212

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

236 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized730
2Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized610
3Sichuan Qi Li Pharmaceutical Co., Ltd. romanized540
4Merck Europe B.V.530
5AstraZeneca AB520
6Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized510
7Bard Pharmaceuticals Limited440
8Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized440
9Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized440
10Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized430

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
349
Left the under-review list this week
480

Of these, NMPA published approval-document delivery for 110 (including 104 supplemental applications, not counted as new marketing approvals) and notification delivery for 4; the outcome of the other 366 is to be checked.

Most filings leaving review, by company

Most filings leaving review, by company
#Company (first applicant)FilingsDrugs
1Eli Lilly and Company144
2Novo Nordisk A/S144
3Shanghai Min Wei Bio Technology Co., Ltd. romanized141
4F. Hoffmann-La Roche Ltd133
5Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized96
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized93
7Xin Da Bio Technology Co., Ltd. romanized81
8AstraZeneca AB73
9Novartis Pharma AG65
10Sanofi-Aventis Recherche & Développement65

Most filings entering review, by company

Most filings entering review, by company
#Company (first applicant)FilingsDrugs
1Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized73
2Merck Europe B.V.53
3AstraZeneca AB52
4Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized51
5Bard Pharmaceuticals Limited44
6Guangxi Wan Tong Pharmaceutical Co., Ltd. romanized44
7Jin Yao Da Ren Tang Group Co., Ltd. Da Ren Tang Pharmaceutical Factory romanized44
8Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized43
9Topfond Pharmaceutical Co., Ltd.43
10Novo Nordisk A/S42

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

90 this week

AcceptedDrugApplicants
2026/10/29Import · Class 2.4 Seladelpar胶囊 · No verified English nameJXHL2600470 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Cilofexor片 · No verified English nameJXHL2600469 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Cilofexor片 · No verified English nameJXHL2600468 Gilead Sciences Inc.; Gilead Sciences Shanghai Pharmaceutical Technology Co. Ltd.
2026/10/29Import · Class 1 Casdatifan 片 · No verified English nameJXHL2600467 Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2026/10/29Import · Class 1 Casdatifan 片 · No verified English nameJXHL2600466 Arcus Biosciences Inc.; PPD Pharmaceutical Development (Beijing) Co. Ltd.
2026/10/29Generic · Class 3 硫酸锌注射液 · No verified English nameCYHS2602647 Shandong Qidu Pharmaceutical Co., Ltd.
2026/10/29Generic · Class 3 Alendronate Sodium Oral SolutionCYHS2602641 Jiangsu Bei Jia Pharmaceutical Co., Ltd. romanized
2026/10/29New drug · Class 2.2; 2.3 小儿清热消炎宁颗粒 · No verified English nameCXZS2600057 Tian Di Heng Yi Pharmaceutical Co., Ltd. romanized
2026/10/29New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2600176 Le Pu Pharma Co., Ltd. romanized; Le Pu (Beijing) Bio Technology Co., Ltd. romanized
2026/10/29New drug · Class 3.3 度拉糖肽注射液 · No verified English nameCXSS2600175 Le Pu Pharma Co., Ltd. romanized; Le Pu (Beijing) Bio Technology Co., Ltd. romanized
2026/10/29New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2601189 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/10/29New drug · Class 1 QI-019D注射液 · No verified English nameCXSL2601188 Qi Han (Shanghai) Bio Technology Co., Ltd. romanized
2026/10/29New drug · Class 1 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2601187 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2026/10/29New drug · Class 1 注射用重组人源化抗BCMA/CD3双特异性抗体 · No verified English nameCXSL2601186 Shandong Xin Shi Dai Pharma Co., Ltd. romanized
2026/10/29New drug · Class 1 RGT-274-CR片 · No verified English nameCXHL2601330 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/10/29New drug · Class 1 RGT-274-CR片 · No verified English nameCXHL2601329 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/10/29New drug · Class 1 RGT-274-CR片 · No verified English nameCXHL2601328 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/10/29New drug · Class 1 RGT-274-CR片 · No verified English nameCXHL2601327 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/10/29New drug · Class 1 RGT-274-CR片 · No verified English nameCXHL2601326 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/10/29New drug · Class 1 RGT-274-CR片 · No verified English nameCXHL2601325 Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized
2026/10/28Import · Class 1 ABBV-706注射用冻干粉 · No verified English nameJXSL2600289 AbbVie Inc.; AbbVie Pharmaceutical Trading (Shanghai) Co. Ltd.
2026/10/28Import · Class 1 AZD0486 · No verified English nameJXSL2600288 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/28Import · Class 1 AZD0486 · No verified English nameJXSL2600287 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/28Import · Class 1 AZD4512 · No verified English nameJXSL2600286 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/10/28Generic · Class 3 复方电解质维持液 · No verified English nameCYHS2602639 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2026/10/28Generic · Class 3 复方电解质维持液 · No verified English nameCYHS2602638 Nanjing En Tai Pharmaceuticals Technology Co., Ltd. romanized; Guangdong Da Xiang Pharmaceutical Co., Ltd. romanized
2026/10/28New drug · Class 2.3 欣力康颗粒 · No verified English nameCXZL2600110 Guiyang Xin Tian Pharma Co., Ltd. romanized
2026/10/28New drug · Class 2.2 注射用瑞康曲妥珠单抗 · No verified English nameCXSS2600174 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Name not romanized
2026/10/28New drug · Class 1 注射用GFS784 · No verified English nameCXSL2601185 Jin Fang Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/10/28New drug · Class 1 CG001注射液 · No verified English nameCXSL2601184 Shanghai Kang Jing Biopharmaceuticals Technology Co., Ltd. romanized

60 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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