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YaoGeJuCDE public lists · weekly counts

National Drug-Review Weekly

The available CDE acceptance records list 343 drug applications between 21 May 2026 and 27 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 16, covering 13 drug names.

2026/05/21 – 2026/05/27

Period
2026/05/21 to 2026/05/27, 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
343
Drugs with new generic filings (by drug name, de-duplicated)
13
Accepted this week, now under review
37

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

343filings, 16 of them generic

By application type

Application typeFilings
Supplement245
New drug48
Import17
Generic16
Unspecified12
Import re-registration5

By drug type

Drug typeFilings
TCM177
Chemical drug117
Therapeutic biologic43
Biologic4
Prophylactic 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

13 drugs with new generic filings; top 10 listed

#DrugNew generic filingsFiling companiesUnder review, all years
1Procaterol Hydrochloride Oral Solution2112
2Milnacipran Hydrochloride Tablets218
3Ketorolac Tromethamine Injection214
4Linaclotide Capsules1113
5Ibuprofen Suspension1114
6Letermovir Injection116
7Loratadine Tablets115
8Landiolol Hydrochloride for Injection1119
9Cefcapene Pivoxil Hydrochloride Granules1111
10Oxybuprocaine Hydrochloride Eye Drops1110

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

214 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
3Hunan De Kang Pharmaceutical Co., Ltd. romanized550
4Chongqing Xi Er An Pharma Co., Ltd. romanized550
5Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized530
6Jiangsu Hao Sen Pharma Group Co., Ltd. romanized520
7EUROAPI Germany GmbH440
8Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized440
9Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized440
10Guizhou Sheng Ke Hui Pharmaceutical 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

70 this week

AcceptedDrugApplicants
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.
2026/05/26Import · Class 1 RAP-219片 · No verified English nameJXHL2600185 Rapport Therapeutics Inc.; Tenacia Biopharmaceuticals (Shanghai) Co. Ltd.
2026/05/26Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2601197 Hebei Wan Long Pharma Co., Ltd. romanized; Hebei Long Hai Pharma Co., Ltd. romanized
2026/05/26Generic · Class 3 Milnacipran Hydrochloride TabletsCYHS2601196 Hebei Wan Long Pharma Co., Ltd. romanized; Hebei Long Hai Pharma Co., Ltd. romanized
2026/05/26Generic · Class 3 Landiolol Hydrochloride for InjectionCYHS2601195 Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Chengdu Tong De Pharma Co., Ltd. romanized
2026/05/26New drug · Class 1 AVL-102 注射液 · No verified English nameCXSL2600572 Beijing An Wei Tuo Biopharmaceuticals Co., Ltd. romanized; An Wei Tuo (Gu An) Biopharmaceuticals Co., Ltd. romanized; An Wei Tuo (Yan Tai) Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/26New drug · Class 1 AVL-102 注射液 · No verified English nameCXSL2600571 Beijing An Wei Tuo Biopharmaceuticals Co., Ltd. romanized; An Wei Tuo (Gu An) Biopharmaceuticals Co., Ltd. romanized; An Wei Tuo (Yan Tai) Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/26New drug · Class 1 9MW5211注射液 · No verified English nameCXSL2600570 Mai Wei (Shanghai) Bio Technology Co., Ltd. romanized
2026/05/26New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHL2600627 Shijiazhuang Kang Li Pharma Co., Ltd. romanized
2026/05/26New drug · Class 2.2 氢溴酸伏硫西汀口崩片 · No verified English nameCXHL2600626 Shijiazhuang Kang Li Pharma Co., Ltd. romanized
2026/05/25Import · Class 2.2 伊奈利珠单抗注射液 · No verified English nameJXSL2600120 Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd.
2026/05/25Import · Class 1 PFL-721片 · No verified English nameJXHL2600184 PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd.
2026/05/25Import · Class 1 PFL-721片 · No verified English nameJXHL2600183 PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd.
2026/05/25New drug · Class 3.1 清心莲子饮颗粒 · No verified English nameCXZS2600027 Yunnan Bai Yao Group Co., Ltd. romanized
2026/05/25New drug · Class 1 NK细胞注射液 · No verified English nameCXSL2600569 Jing Dong Fang Zai Sheng Yi Xue Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 RJK-RT2831注射液 · No verified English nameCXSL2600568 Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 Tvac001新抗原反应性T细胞注射液 · No verified English nameCXSL2600567 Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 SGC001注射液 · No verified English nameCXSL2600566 Beijing Shun Jing Biopharmaceuticals Technology Co., Ltd. romanized
2026/05/25New drug · Class 1 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600625 Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized

40 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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