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
- 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 type | Filings |
|---|---|
| Supplement | 242 |
| New drug | 43 |
| Generic | 24 |
| Import | 15 |
| Unspecified | 12 |
| Import re-registration | 3 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 161 |
| Chemical drug | 137 |
| Therapeutic biologic | 34 |
| Biologic | 4 |
| Prophylactic biologic | 3 |
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
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sufentanil Citrate Injection | 5 | 1 | 0 |
| 2 | 瑞维那新吸入溶液 · No verified English name | 2 | 2 | 53 |
| 3 | 口服溶液用盐酸万古霉素 · No verified English name | 2 | 1 | 2 |
| 4 | Milnacipran Hydrochloride Tablets | 2 | 1 | 8 |
| 5 | Ketorolac Tromethamine Injection | 2 | 1 | 4 |
| 6 | 二硫化硒洗剂 · No verified English name | 1 | 1 | 14 |
| 7 | Linaclotide Capsules | 1 | 1 | 13 |
| 8 | 吸入用布地奈德混悬液 · No verified English name | 1 | 1 | 7 |
| 9 | Ibuprofen Suspension | 1 | 1 | 14 |
| 10 | Letermovir Injection | 1 | 1 | 6 |
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) | 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 | Beijing Tong Ren Tang Co., Ltd. Tong Ren Tang Pharmaceutical Factory romanized | 5 | 3 | 0 |
| 4 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 5 | 2 | 0 |
| 5 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 5 | 1 | 5 |
| 6 | EUROAPI Germany GmbH | 4 | 4 | 0 |
| 7 | Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Guizhou Sheng Ke Hui Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Rapport Therapeutics Inc. | 4 | 1 | 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
71 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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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