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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 438 drug applications between 9 January 2026 and 15 January 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 94, covering 68 drug names.

2026/01/09 – 2026/01/15

Period
2026/01/09 to 2026/01/15, 7 days inclusive
Data as of
2026/11/14 06:00
Cached records
94,880 acceptance records, 11,632 under review now
Source
Public data from the CDE acceptance list and under-review list
New acceptances this week
438
Drugs with new generic filings (by drug name, de-duplicated)
68
Accepted this week, now under review
117

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

438filings, 94 of them generic

By application type

Application typeFilings
Supplement209
New drug100
Generic94
Import22
Unspecified7
Import re-registration6

By drug type

Drug typeFilings
Chemical drug252
TCM99
Therapeutic biologic77
Prophylactic biologic9
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

68 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Loxoprofen Sodium Patches6330
2Oseltamivir Phosphate Capsules4239
3Azilsartan Medoxomil Potassium Tablets4235
4Brimonidine Tartrate Eye Drops324
5Adapalene And Benzoyl Peroxide Gel2230
6复方电解质醋酸钠葡萄糖注射液 · No verified English name2122
7Dotinurad Tablets2155
8Baricitinib Tablets2132
9Brivaracetam Tablets2119
10Telmisartan Tablets214

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
1Hunan Jiu Dian Nuo Na Pharmaceuticals Technology Co., Ltd. romanized38380
2Eli Lilly Nederland B.V.1210
3Rui Li Shi Wan Ting Min Xin Pharmaceutical Co., Ltd. romanized1120
4Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized910
5Bayer Vital GmbH840
6Gan Li Pharma Shandong Co., Ltd. romanized810
7Novo Nordisk A/S620
8Name not romanized610
9Hunan Ke Lun Pharmaceutical Co., Ltd. romanized542
10Boehringer Ingelheim International GmbH530

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

147 this week

AcceptedDrugApplicants
2026/01/15Import · Class 2.4 Selexipag TabletsJXHL2600011 Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd.
2026/01/15Import · Class 2.4 Selexipag TabletsJXHL2600010 Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd.
2026/01/15Import · Class 2.4 Selexipag TabletsJXHL2600009 Actelion Pharmaceuticals Ltd; Johnson & Johnson (China) Investment Ltd.
2026/01/15Generic · Class 3 盐酸羟甲唑啉滴眼液 · No verified English nameCYHL2600011 NANJING ZENKOM PHARMACEUTICAL CO.,LTD.
2026/01/15New drug · Class 1.1 轻身调脂消渴片 · No verified English nameCXZL2600006 Jiangsu Jiu Xu Pharma Co., Ltd. romanized; Hainan Jiu Xu Pharmaceuticals Technology Co., Ltd. romanized; Zhongguo Zhong Yi Ke College Guang An Men Hospital romanized
2026/01/15New drug · Class 1 SPX-303注射液 · No verified English nameCXSL2600088 Ke Ba Bio (Jiangsu) Co., Ltd. romanized
2026/01/15New drug · Class 1 GLR1062注射液 · No verified English nameCXSL2600087 Gan Li Pharma Co., Ltd. romanized
2026/01/15New drug · Class 3.3 9MW4113注射液 · No verified English nameCXSL2600086 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/01/15New drug · Class 1 PRO-203 · No verified English nameCXSL2600085 Beijing MEDPACE Pharmaceuticals Technology Co., Ltd. romanized
2026/01/15New drug · Class 2.4 MI226注射液 · No verified English nameCXHL2600077 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/01/15New drug · Class 2.4 MI226注射液 · No verified English nameCXHL2600076 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/01/15New drug · Class 2.4 MI226注射液 · No verified English nameCXHL2600075 Nanjing Mai Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized
2026/01/15New drug · Class 1 JKN2404吸入混悬液 · No verified English nameCXHL2600074 Health Yuan Pharma Group Co., Ltd. romanized
2026/01/15New drug · Class 1 JKN2404吸入混悬液 · No verified English nameCXHL2600073 Health Yuan Pharma Group Co., Ltd. romanized
2026/01/15New drug · Class 1 JKN2404吸入混悬液 · No verified English nameCXHL2600072 Health Yuan Pharma Group Co., Ltd. romanized
2026/01/15New drug · Class 1 BSA204注射液 · No verified English nameCXHL2600071 Bei Zhen Bio Technology (Suzhou) Co., Ltd. romanized
2026/01/14Import · Class 2.2 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2600004 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/01/14Import · Class 2.2 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2600003 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/01/14Import · Class 2.2 依柯胰岛素司美格鲁肽注射液 · No verified English nameJXSS2600002 Novo Nordisk A/S; Novo Nordisk (China) Pharmaceuticals Co. Ltd.
2026/01/14Import · Class 2.2 可伐利单抗注射液 · No verified English nameJXSL2600003 F.Hoffmann-La Roche Ltd; Roche(China) Holding Ltd
2026/01/14Generic · Class 3 Dihydroxyaluminum Aminoacetate, Heavy Magnesium Carbonate and Aspirin Tablets(Ⅱ)CYHS2600174 Hainan Hai Ling Chemical Pharmaceutical Co., Ltd. romanized
2026/01/14Generic · Class 3 Propranolol Hydrochloride InjectionCYHS2600173 Beijing Hua Su Pharmaceutical Co., Ltd. romanized
2026/01/14Generic · Class 3 6-[18F]Fluoro-L-DOPA InjectionCYHL2600010 Jiangsu Vanguard Pharmaceutical Co., Ltd.
2026/01/14New drug · Class 2.2 双苓止泻颗粒 · No verified English nameCXZL2600005 Tai Ji Group Chongqing Fu Ling Pharmaceutical Factory Co., Ltd. romanized
2026/01/14New drug · Class 1 注射用HDM2024 · No verified English nameCXSL2600084 Hangzhou Zhong Mei Hua Dong Pharmaceutical Co., Ltd. romanized
2026/01/14New drug · Class 3.3 IBI3027 · No verified English nameCXSL2600083 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/01/14New drug · Class 3.3 IBI3027 · No verified English nameCXSL2600082 Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized
2026/01/14New drug · Class 1 Pumitamig注射液 · No verified English nameCXSL2600081 Bai Shi Mei Shi Gui Bao (Zhongguo) Investment Co., Ltd. romanized; Bai Ou En Tai (Shanghai) Pharmaceuticals Co., Ltd. romanized
2026/01/14New drug · Class 3.3 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSL2600080 Beijing Ji Nuo Wei Bio Technology Co., Ltd. romanized; Ji Nuo Wei (Lang Fang Lin Kong Zi Mao Qu) Bio Zhi Pin Co., Ltd. romanized; Ji Nuo Wei (Hebei) Bio Technology Co., Ltd. romanized; Changchun Hai Ji Ya Bio Technology Co., Ltd. romanized
2026/01/14New drug · Class 1 FKC289注射液 · No verified English nameCXSL2600079 Fu Xing Kai Rui (Shanghai) Bio Technology Co., Ltd. romanized

117 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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