YaoGeJu

YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 311 drug applications between 4 October 2026 and 10 October 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 56, covering 39 drug names.

2026/10/04 – 2026/10/10

Period
2026/10/04 to 2026/10/10, 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
311
Drugs with new generic filings (by drug name, de-duplicated)
39
Accepted this week, now under review
274

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

311filings, 56 of them generic

By application type

Application typeFilings
Supplement159
New drug60
Generic56
Import15
Import re-registration15
Unspecified6

By drug type

Drug typeFilings
Chemical drug180
TCM83
Therapeutic biologic47
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

39 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Ixazomib Citrate Capsules317
2Dihydrocodeine Tartrate Sustained Realese Tablets313
3Glucosamine Sulfate Capsules2251
4Mupirocin Ointment2230
5Allopurinol Tablets214
6Dotinurad Tablets2155
7Brivaracetam Tablets2119
8Ticagrelor Tablets2110
9Losartan Potassium Tablets215
10Sacubitril Valsartan Sodium Tablets2170

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

180 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Dong E E Jiao Co., Ltd. romanized11110
2Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized820
3N. V. Organon810
4Upjohn Manufacturing Ireland Unlimited Company610
5Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized610
6Merck Europe B.V.520
7Bristol- Myers Squibb Australia Pty Ltd510
8AstraZeneca AB420
9Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized420
10Jiangsu Hao Sen Pharma Group Co., Ltd. romanized420

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

96 this week

AcceptedDrugApplicants
2026/10/10Import · Class 1 Tilrekimig注射液 · No verified English nameJXSL2600269 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/10/10Import · Class 1 Tilrekimig注射液 · No verified English nameJXSL2600268 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/10/10Import · Class 1 Tilrekimig注射液 · No verified English nameJXSL2600267 Pfizer Inc.; Pfizer Investment CO. Ltd.
2026/10/10Import · Class 2.4 玛伐凯泰胶囊 · No verified English nameJXHS2600128 Bristol- Myers Squibb Australia Pty Ltd; Patheon Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/10/10Import · Class 2.4 玛伐凯泰胶囊 · No verified English nameJXHS2600127 Bristol- Myers Squibb Australia Pty Ltd; Patheon Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/10/10Import · Class 2.4 玛伐凯泰胶囊 · No verified English nameJXHS2600126 Bristol- Myers Squibb Australia Pty Ltd; Patheon Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/10/10Import · Class 2.4 玛伐凯泰胶囊 · No verified English nameJXHS2600125 Bristol- Myers Squibb Australia Pty Ltd; Patheon Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/10/10Import · Class 2.4 玛伐凯泰胶囊 · No verified English nameJXHS2600124 Bristol- Myers Squibb Australia Pty Ltd; Patheon Inc.; Bristol-Myers Squibb (China) Investment Co. Ltd.
2026/10/10Generic · Class 3 Proparacaine Hydrochloride Eye DropsCYHS2602487 Ya Bang Pharmaceuticals Co., Ltd. romanized
2026/10/10Generic · Class 3 Allopurinol TabletsCYHS2602482 Shanxi Tong Da Pharma Co., Ltd. romanized
2026/10/10Generic · Class 3 Allopurinol TabletsCYHS2602481 Shanxi Tong Da Pharma Co., Ltd. romanized
2026/10/10Generic · Class 3 布美他尼片 · No verified English nameCYHS2602476 Fujian Hai Xi Xin Yao Chuang Zhi Co., Ltd. romanized
2026/10/10Generic · Class 3 Sodium Nitroprusside InjectionCYHS2602475 Dan Dong Yi Chuang Pharma Co., Ltd. romanized
2026/10/10Generic · Class 3 盐酸索他洛尔口服溶液 · No verified English nameCYHS2602474 Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd
2026/10/10Generic · Class 3 碳酸氢钠血滤置换液(钾4mmol/L无钙) · No verified English nameCYHS2602473 Shijiazhuang No.4 Pharmaceutical Co., Ltd.
2026/10/10Generic · Class 3 Ketoprofen PatchesCYHL2600111 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized
2026/10/10Generic · Class 3 Ketoprofen PatchesCYHL2600110 Zhejiang Bai Dai Pharmaceuticals Technology Co., Ltd. romanized
2026/10/10New drug · Class 1.1 百草伤膏凝胶贴膏 · No verified English nameCXZL2600097 Hangzhou Shi Fu Yang Zhong Yi Gu Shang Hospital romanized; Zhejiang Zhong Pharmaceuticals University romanized
2026/10/10New drug · Class 3.4 人凝血因子IX · No verified English nameCXSS2600162 Chengdu Rong Sheng Pharma Co., Ltd. romanized
2026/10/10New drug · Class 1 UMSC01细胞注射液 · No verified English nameCXSL2601096 Shanghai Jiu Qian Cheng Biopharmaceuticals Co., Ltd. romanized
2026/10/10New drug · Class 1 IASO208注射液 · No verified English nameCXSL2601095 Shanghai Xun Lu Bio Technology Co., Ltd. romanized
2026/10/10New drug · Class 1 SYS6010 · No verified English nameCXSL2601094 Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized
2026/10/10New drug · Class 1 注射用HWK-206 · No verified English nameCXSL2601093 Bai Ying Bio Technology (Shanghai) Co., Ltd. romanized
2026/10/10New drug · Class 1 注射用GB268 · No verified English nameCXSL2601092 Yi Teng Pharmaceuticals (Zhuhai) Co., Ltd. romanized
2026/10/10New drug · Class 1 KJ001注射液 · No verified English nameCXSL2601091 Chengdu Kang Jing Bio Technology Co., Ltd. romanized
2026/10/10New drug · Class 2.2 JWL202512 · No verified English nameCXHL2601258 Jewim Pharmaceutical (Shandong) Co., Ltd.
2026/10/10New drug · Class 1 UBT48128片 · No verified English nameCXHL2601257 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2026/10/10New drug · Class 1 UBT48128片 · No verified English nameCXHL2601256 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2026/10/10New drug · Class 1 UBT48128片 · No verified English nameCXHL2601255 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized
2026/10/10New drug · Class 1 UBT48128片 · No verified English nameCXHL2601254 Lian Bang Bio Technology (Zhuhai Heng Qin) Co., Ltd. romanized

66 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.