YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 277 drug applications between 12 February 2026 and 18 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 45, covering 35 drug names.
2026/02/12 – 2026/02/18
- New acceptances this week
- 277
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- Accepted this week, now under review
- 66
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
277filings, 45 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 127 |
| New drug | 63 |
| Generic | 45 |
| Import | 18 |
| Unspecified | 13 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 158 |
| Therapeutic biologic | 65 |
| TCM | 43 |
| Biologic | 7 |
| Prophylactic biologic | 4 |
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
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 2 | 丙泊酚乳状注射液 · No verified English name | 2 | 1 | 3 |
| 3 | 复方氨基酸注射液(18AA-VII) · No verified English name | 2 | 1 | 3 |
| 4 | Paliperidone Extend-release Tablets | 2 | 1 | 2 |
| 5 | Telmisartan Tablets | 2 | 1 | 4 |
| 6 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 7 | Dexmethylphenidate Hydrochloride Exended-release Capsules | 2 | 1 | 2 |
| 8 | Minocycline Hydrochloride Capsules | 2 | 1 | 19 |
| 9 | 磷苯妥英钠注射用浓溶液 · No verified English name | 2 | 1 | 6 |
| 10 | Finerenone Tablets | 2 | 1 | 69 |
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
169 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | AstraZeneca AB | 10 | 4 | 0 |
| 2 | Shanxi Zheng Lai Pharmaceutical Co., Ltd. romanized | 7 | 6 | 0 |
| 3 | Eli Lilly and Company | 6 | 1 | 0 |
| 4 | F. Hoffmann-La Roche Ltd | 6 | 1 | 0 |
| 5 | Roche Pharma (Schweiz) AG | 5 | 3 | 0 |
| 6 | Jing Fu Kang Pharma Group Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Takeda Manufacturing Austria AG | 4 | 1 | 0 |
| 8 | Upjohn US 2 LLC | 4 | 1 | 0 |
| 9 | Guangzhou Xi Que Pharmaceuticals Co., Ltd. romanized | 4 | 1 | 0 |
| 10 | Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized | 3 | 3 | 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
90 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/15New drug · Class 2.4 | 注射用重组A型肉毒毒素(Sf9细胞,150 kD天然氨基酸序列) · No verified English nameCXSL2600232 | Suzhou Ruo Yi Bio Technology Co., Ltd. romanized |
| 2026/02/15New drug · Class 1 | SIR4156片 · No verified English nameCXHL2600208 | Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/02/15New drug · Class 2.2 | 氨酚羟考酮缓释片 · No verified English nameCXHL2600207 | Shanghai Li Xiang Pharmaceutical Co., Ltd. romanized |
| 2026/02/14Import · Class 3.1 | 注射用索特西普 · No verified English nameJXSS2600011 | Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd. |
| 2026/02/14Import · Class 3.1 | 注射用索特西普 · No verified English nameJXSS2600010 | Merck Sharp & Dohme LLC; Patheon Italia S.p.A.; MSD R&D (China) Co. Ltd. |
| 2026/02/14Generic · Class 3 | 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2600488 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized |
| 2026/02/14Generic · Class 3 | 磷苯妥英钠注射用浓溶液 · No verified English nameCYHS2600486 | Hainan Hui Tong Biopharmaceuticals Technology Co., Ltd. romanized; Shandong Bei Da Gao Ke Hua Tai Pharmaceutical Co., Ltd. romanized |
| 2026/02/14Generic · Class 3 | Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2600482 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/02/14Generic · Class 3 | Dexmethylphenidate Hydrochloride Exended-release CapsulesCYHS2600481 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2026/02/14Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2600480 | Jiangxi Tai Ji Li Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | 达尔扑拜单抗注射液 · No verified English nameCXSS2600022 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | 芮特韦拜单抗注射液 · No verified English nameCXSS2600021 | Zhuhai Tai Nuo Mai Bo Pharmaceutical Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | 库莱韦单抗注射液 · No verified English nameCXSS2600020 | Rui Yang (Shandong) Biopharmaceutical Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | YB1-X7注射液 · No verified English nameCXSL2600233 | Shao Xing Shan Wei Te Bio Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | SHR-3079注射液 · No verified English nameCXSL2600231 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | SHR-3079注射液 · No verified English nameCXSL2600230 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/14New drug · Class 2.1 | 人胰岛素肠溶胶囊 · No verified English nameCXSL2600229 | Hefei Tian Hui Bio Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 2.1 | 人胰岛素肠溶胶囊 · No verified English nameCXSL2600228 | Hefei Tian Hui Bio Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | NEWR0919滴眼液 · No verified English nameCXSL2600227 | Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | NEWR0919滴眼液 · No verified English nameCXSL2600226 | Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | NEWR0919滴眼液 · No verified English nameCXSL2600225 | Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | SHR-1819注射液 · No verified English nameCXSL2600223 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | SHR-1819注射液 · No verified English nameCXSL2600222 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | 注射用DEC003M · No verified English nameCXSL2600221 | Hangzhou Duo Xi Bio Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | 注射用SIBP-A17 · No verified English nameCXSL2600220 | Shanghai Bio Zhi Pin Research Institute Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | 注射用TUL108 · No verified English nameCXHL2600206 | Zhuhai Lian Bang Pharmaceutical Co., Ltd. romanized |
| 2026/02/14New drug · Class 2.2 | NH601缓释胶囊 · No verified English nameCXHL2600205 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 2.2 | NH601缓释胶囊 · No verified English nameCXHL2600204 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 2.2 | NH601缓释胶囊 · No verified English nameCXHL2600203 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/14New drug · Class 1 | VV261片 · No verified English nameCXHL2600202 | Wang Shan Wang Shui (Shanghai) Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized; Suzhou Wang Shan Wang Shui Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Wuhan Bing Du Research Institute romanized |
60 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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