YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 481 drug applications between 7 August 2026 and 13 August 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 85, covering 59 drug names.

2026/08/07 – 2026/08/13

Period
2026/08/07 to 2026/08/13, 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
481
Drugs with new generic filings (by drug name, de-duplicated)
59
Accepted this week, now under review
246

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

481filings, 85 of them generic

By application type

Application typeFilings
Supplement286
Generic85
New drug63
Import32
Import re-registration8
Unspecified7

By drug type

Drug typeFilings
Chemical drug230
TCM172
Therapeutic biologic71
Prophylactic biologic6
Biologic2

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

59 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Dapagliflozin Tablets4284
2注射用磷酸左奥硝唑酯二钠 · No verified English name3222
3苯磺酸左氨氯地平片 · No verified English name3245
4Brexpiprazole Orally Disintegrating Tablets3110
5Brexpiprazole Tablets3131
6鱼油(3%)橄榄油中/长链脂肪乳/氨基酸(16)/葡萄糖(13%)注射液 · No verified English name316
7Lactulose Oral Solution2234
8Ferrous Succinate Tablets2220
9盐酸阿莫罗芬搽剂 · No verified English name2215
10Mupirocin Ointment2230

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

292 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Jilin Gao Miao Pharma Co., Ltd. romanized880
2AstraZeneca AB850
3Xin Da Bio Technology Co., Ltd. romanized810
4Liaoning Shang Yao Hao Hu Shi Pharma (Group) Co., Ltd. romanized750
5Novo Nordisk A/S710
6F. Hoffmann-La Roche Ltd610
7Sichuan Tai Le Pharmaceutical Co., Ltd. romanized550
8Heng Yi Biopharmaceuticals (Jiangsu) Co., Ltd. romanized510
9Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized440
10Qinghai Di Ma Er Zang Yao 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

121 this week

AcceptedDrugApplicants
2026/08/13Import · Class 3.1 阿柏西普眼内注射溶液 · No verified English nameJXSS2600073 Bayer AG; Bayer Healthcare Company Ltd.
2026/08/13Import · Class 2.4 Finerenone TabletsJXHS2600089 Bayer AG; Bayer Healthcare Company Ltd.
2026/08/13Import · Class 2.4 Finerenone TabletsJXHS2600088 Bayer AG; Bayer Healthcare Company Ltd.
2026/08/13Generic · Class 3 Idebenone TabletsCYHS2602008 Qilu Pharmaceutical Co., Ltd.
2026/08/13Generic · Class 3 Ferrous Succinate TabletsCYHS2601997 Zhejiang Qian Jin Pharma Co., Ltd. romanized
2026/08/13Generic · Class 3 Levofloxacin Oral SolutionCYHS2601992 Jilin Sheng Hui Nan Chang Long Sheng Hua Pharma Co., Ltd. romanized
2026/08/13Generic · Class 3 Glycerol Fructose And Sodium Chloride InjectionCYHS2601988 Chi Feng Yuan Sheng Pharma Co., Ltd. romanized
2026/08/13New drug · Class 1 HB0056注射液 · No verified English nameCXSL2600863 Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized
2026/08/13New drug · Class 1 ZHB 103注射液 · No verified English nameCXSL2600862 Jiangsu Zhong Hong Bio Gong Cheng Chuang Yao Research Institute Co., Ltd. romanized
2026/08/13New drug · Class 2.4 RY001 注射用重组A型肉毒毒素(大肠杆菌) · No verified English nameCXSL2600861 Chengdu Rui Yi Bio Technology Co., Ltd. romanized
2026/08/13New drug · Class 1 FG-M108注射液 · No verified English nameCXSL2600860 Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized
2026/08/13New drug · Class 1 ACE723 · No verified English nameCXSL2600859 Ai Si Bo Di Ya (Shanghai) Bio Technology Co., Ltd. romanized
2026/08/13New drug · Class 1 注射用SAL012 · No verified English nameCXSL2600858 Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized
2026/08/13New drug · Class 1 注射用SHR-8925 · No verified English nameCXSL2600857 Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized
2026/08/13New drug · Class 1 BC923注射液 · No verified English nameCXHL2601000 Beijing Bo Yuan Run Bu Pharmaceuticals Research and Development Co., Ltd. romanized
2026/08/13New drug · Class 1 HTMC0658片 · No verified English nameCXHL2600999 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/08/13New drug · Class 1 HTMC0658片 · No verified English nameCXHL2600998 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/08/13New drug · Class 1 HTMC0658片 · No verified English nameCXHL2600997 Shanghai Yi Dian Pharmaceuticals Technology Kai Fa Co., Ltd. romanized
2026/08/13New drug · Class 1 VC005凝胶 · No verified English nameCXHL2600996 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2026/08/13New drug · Class 1 VC005凝胶 · No verified English nameCXHL2600995 Jiangsu Wei Kai Er Pharmaceuticals Technology Co., Ltd. romanized
2026/08/13New drug · Class 2.2 YR-2316吸入粉雾剂 · No verified English nameCXHL2600994 Yangtze River Pharmaceutical Group Co., Ltd; Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized
2026/08/13New drug · Class 2.2 YR-2316吸入粉雾剂 · No verified English nameCXHL2600993 Yangtze River Pharmaceutical Group Co., Ltd; Yang Zi Jiang Pharma Group Nanjing Hai Ling Pharma Co., Ltd. romanized
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600206 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600205 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600204 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600203 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600202 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 RO7589655注射液 · No verified English nameJXSL2600201 F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd.
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600200 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd
2026/08/12Import · Class 1 zenagamtide注射液 · No verified English nameJXSL2600199 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd

91 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.