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
- 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 type | Filings |
|---|---|
| Supplement | 245 |
| New drug | 48 |
| Import | 17 |
| Generic | 16 |
| Unspecified | 12 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 177 |
| Chemical drug | 117 |
| Therapeutic biologic | 43 |
| Biologic | 4 |
| Prophylactic biologic | 2 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Procaterol Hydrochloride Oral Solution | 2 | 1 | 12 |
| 2 | Milnacipran Hydrochloride Tablets | 2 | 1 | 8 |
| 3 | Ketorolac Tromethamine Injection | 2 | 1 | 4 |
| 4 | Linaclotide Capsules | 1 | 1 | 13 |
| 5 | Ibuprofen Suspension | 1 | 1 | 14 |
| 6 | Letermovir Injection | 1 | 1 | 6 |
| 7 | Loratadine Tablets | 1 | 1 | 5 |
| 8 | Landiolol Hydrochloride for Injection | 1 | 1 | 19 |
| 9 | Cefcapene Pivoxil Hydrochloride Granules | 1 | 1 | 11 |
| 10 | Oxybuprocaine Hydrochloride Eye Drops | 1 | 1 | 10 |
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) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 11 | 9 | 0 |
| 2 | Anhui De Hong Sheng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 3 | Hunan De Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 4 | Chongqing Xi Er An Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 6 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | EUROAPI Germany GmbH | 4 | 4 | 0 |
| 8 | Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Guizhou Sheng Ke Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
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
| Accepted | Drug | Applicants |
|---|---|---|
| 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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