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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 339 drug applications between 22 May 2026 and 28 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 24, covering 16 drug names.

2026/05/22 – 2026/05/28

Period
2026/05/22 to 2026/05/28, 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
339
Drugs with new generic filings (by drug name, de-duplicated)
16
Accepted this week, now under review
41

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

339filings, 24 of them generic

By application type

Application typeFilings
Supplement242
New drug43
Generic24
Import15
Unspecified12
Import re-registration3

By drug type

Drug typeFilings
TCM161
Chemical drug137
Therapeutic biologic34
Biologic4
Prophylactic biologic3

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

16 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Sufentanil Citrate Injection510
2瑞维那新吸入溶液 · No verified English name2253
3口服溶液用盐酸万古霉素 · No verified English name212
4Milnacipran Hydrochloride Tablets218
5Ketorolac Tromethamine Injection214
6二硫化硒洗剂 · No verified English name1114
7Linaclotide Capsules1113
8吸入用布地奈德混悬液 · No verified English name117
9Ibuprofen Suspension1114
10Letermovir Injection116

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

216 companies with new acceptances; top 10 listed

#Company (first applicant)FilingsDrugsGeneric
1Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized1190
2Anhui De Hong Sheng Pharmaceutical Co., Ltd. romanized550
3Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized530
4Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520
5Yi Chang Ren Fu Pharma Co., Ltd. romanized515
6EUROAPI Germany GmbH440
7Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized440
8Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized440
9Guizhou Sheng Ke Hui Pharmaceutical Co., Ltd. romanized440
10Rapport Therapeutics Inc.410

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

71 this week

AcceptedDrugApplicants
2026/05/28Import · Class 2.4 甲磺酸亮丙瑞林注射液(6M) · No verified English nameJXHS2600057 Accord BioPharma Inc.; Fareva Pau; Changchun GeneScience Pharmaceuticals Co. Ltd.
2026/05/28Generic · Class 3 二硫化硒洗剂 · No verified English nameCYHS2601208 Hubei Ke Tian Pharma Co., Ltd. romanized
2026/05/28Generic · Class 3 口服溶液用盐酸万古霉素 · No verified English nameCYHS2601207 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/05/28Generic · Class 3 口服溶液用盐酸万古霉素 · No verified English nameCYHS2601206 Huayi Pharmaceuticals (Anhui) Co., Ltd.
2026/05/28Generic · Class 3 Sufentanil Citrate InjectionCYHL2600068 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/05/28Generic · Class 3 Sufentanil Citrate InjectionCYHL2600067 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/05/28Generic · Class 3 Sufentanil Citrate InjectionCYHL2600066 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/05/28Generic · Class 3 Sufentanil Citrate InjectionCYHL2600065 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/05/28Generic · Class 3 Sufentanil Citrate InjectionCYHL2600064 Yi Chang Ren Fu Pharma Co., Ltd. romanized
2026/05/28New drug · Class 1 ADG138注射液 · No verified English nameCXSL2600579 Tian Yan Pharma (Suzhou) Co., Ltd. romanized
2026/05/28New drug · Class 1 注射用LBL-024 · No verified English nameCXSL2600578 Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized
2026/05/28New drug · Class 1.2 重组B群脑膜炎球菌多组分疫苗 · No verified English nameCXSL2600577 Suzhou Ju Wei Bio Technology Co., Ltd. romanized
2026/05/28New drug · Class 1 SHR-8203注射液 · No verified English nameCXSL2600576 Beijing Sheng Di Pharmaceuticals Co., Ltd. romanized
2026/05/28New drug · Class 2.2; 2.4 玛舒拉沙韦干混悬剂 · No verified English nameCXHS2600077 Jiangxi Ke Rui Pharma Co., Ltd. romanized
2026/05/28New drug · Class 2.4 奥布替尼片 · No verified English nameCXHS2600076 Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Guangzhou Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized; Changzhou He Quan Pharma Co., Ltd. romanized; Wuxi He Quan Pharma Co., Ltd. romanized
2026/05/28New drug · Class 2.3 恩格列净叶酸片 · No verified English nameCXHL2600631 Shenzhen Ao Sa Pharmaceutical Co., Ltd. romanized
2026/05/28New drug · Class 1 HSK51155片 · No verified English nameCXHL2600630 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2026/05/28New drug · Class 1 HSK51155片 · No verified English nameCXHL2600629 Hai Si Ke Pharmaceuticals Group Co., Ltd. romanized
2026/05/27Import · Class 1 贝普若韦生注射液 · No verified English nameJXHS2600056 GlaxoSmithKline Trading Services Limited; GLAXO OPERATIONS UK LTD TRADING AS GLAXO WELLCOME OPERATIONS; GlaxoSmithKline (China) Investment Company Limited
2026/05/27Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2601200 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/05/27Generic · Class 3 Ketorolac Tromethamine InjectionCYHS2601199 Jiangsu Fu Bang Pharma Co., Ltd. romanized
2026/05/27New drug · Class 1 EX103注射液 · No verified English nameCXSL2600575 Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/27New drug · Class 1 注射用HLX43 · No verified English nameCXSL2600574 Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Rui Lin Bio Technology Co., Ltd. romanized
2026/05/27New drug · Class 1 注射用YXC-001 · No verified English nameCXSL2600573 Shanghai You Xi Chuang Pharmaceuticals Technology Co., Ltd. romanized
2026/05/27New drug · Class 1 MWN117注射液 · No verified English nameCXHL2600628 Shanghai Min Wei Bio Technology Co., Ltd. romanized
2026/05/26Import · Class 1 Nolasiban分散片 · No verified English nameJXHL2600190 ReproNovo SA; Pharmaron (Chengdu) Clinical Services Co. Ltd.
2026/05/26Import · Class 1 Balcinrenone达格列净胶囊 · No verified English nameJXHL2600189 AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd.
2026/05/26Import · Class 1 RAP-219片 · No verified English nameJXHL2600188 Rapport Therapeutics Inc.; Tenacia Biopharmaceuticals (Shanghai) Co. Ltd.
2026/05/26Import · Class 1 RAP-219片 · No verified English nameJXHL2600187 Rapport Therapeutics Inc.; Tenacia Biopharmaceuticals (Shanghai) Co. Ltd.
2026/05/26Import · Class 1 RAP-219片 · No verified English nameJXHL2600186 Rapport Therapeutics Inc.; Tenacia Biopharmaceuticals (Shanghai) Co. Ltd.

41 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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