YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 409 drug applications between 30 August 2025 and 5 September 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 125, covering 85 drug names.
2025/08/30 – 2025/09/05
- New acceptances this week
- 409
- Drugs with new generic filings (by drug name, de-duplicated)
- 85
- Accepted this week, now under review
- 131
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
409filings, 125 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 162 |
| Generic | 125 |
| New drug | 70 |
| Import | 37 |
| Unspecified | 9 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 278 |
| TCM | 62 |
| Therapeutic biologic | 59 |
| Biologic | 9 |
| Prophylactic biologic | 1 |
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
85 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 9 | 3 | 70 |
| 2 | Polidocanol Injection | 4 | 2 | 23 |
| 3 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 4 | Ozagrel Sodium Injection | 3 | 1 | 3 |
| 5 | 左羟丙哌嗪口服溶液 · No verified English name | 3 | 1 | 8 |
| 6 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 7 | Ceftazidime And Avibactam Sodium For Injection | 2 | 2 | 12 |
| 8 | Rivaroxaban Tablets | 2 | 1 | 3 |
| 9 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 10 | 小儿复方氨基酸注射液(19AA-Ⅰ) · No verified English name | 2 | 1 | 1 |
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
236 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Jian Bin Pharmaceuticals Technology Co., Ltd. romanized | 12 | 11 | 0 |
| 2 | Eli Lilly and Company | 11 | 3 | 0 |
| 3 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 11 | 2 | 0 |
| 4 | Topfond Pharmaceutical Co., Ltd. | 8 | 8 | 0 |
| 5 | Novo Nordisk A/S | 7 | 3 | 0 |
| 6 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized | 5 | 3 | 4 |
| 7 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized | 5 | 2 | 5 |
| 8 | Takeda Canada Inc | 5 | 1 | 0 |
| 9 | Terumo Corporation Kofu Factory | 5 | 1 | 0 |
| 10 | Hubei Ke Lun Pharma Co., Ltd. romanized | 5 | 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
153 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/09/05Import · Class 3.1 | 注射用伏索利肽 · No verified English nameJXSS2500121 | BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd |
| 2025/09/05Import · Class 3.1 | 注射用伏索利肽 · No verified English nameJXSS2500120 | BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd |
| 2025/09/05Import · Class 3.1 | 注射用伏索利肽 · No verified English nameJXSS2500119 | BioMarin International Limited; Vetter Pharma-Fertigung GmbH & Co. KG; PAREXEL China Co. Ltd |
| 2025/09/05Import · Class 1 | ACE1831 · No verified English nameJXSL2500168 | Acepodia Biotech Inc.; Syneos Health(Beijing)Inc. Ltd. |
| 2025/09/05Import · Class 1 | 注射用RO7837195 · No verified English nameJXSL2500167 | Genentech Inc. |
| 2025/09/05Import · Class 2.4 | 阿贝西利片 · No verified English nameJXHS2500096 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2025/09/05Import · Class 2.4 | 阿贝西利片 · No verified English nameJXHS2500095 | Eli Lilly Nederland B.V.; Lilly del Caribe Inc.; Lilly Suzhou Pharmaceutical Co. Ltd |
| 2025/09/05Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500262 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/05Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500261 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/05Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500260 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/05Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500259 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/05Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500258 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/05Import · Class 1 | Orforglipron片 · No verified English nameJXHL2500257 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2025/09/05Generic · Class 3 | Thioctic Acid TabletsCYHS2503299 | Fujian Sheng Bao Nuo Pharmaceuticals Research and Development Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/09/05Generic · Class 3 | 中性腹膜透析液(乳酸盐-G1.5%) · No verified English nameCYHS2503298 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2025/09/05Generic · Class 3 | Articaine Hydrochloride And Epinephrine InjectionCYHS2503297 | Jiangsu Run Heng Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | Enalapril Maleate Oral SolutionCYHS2503291 | Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | 西诺氨酯片 · No verified English nameCYHS2503286 | Yi Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | Lidocaine Hydrochloride GelCYHS2503285 | Fujian Da Pu Biopharmaceuticals Co., Ltd. romanized; Wuhan Wei Ao Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | 西诺氨酯片 · No verified English nameCYHS2503284 | Yi Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | 中性腹膜透析液(碳酸氢盐-G1.5%) · No verified English nameCYHS2503280 | Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2503278 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | Erythromycin Lactobionate for InjectionCYHS2503277 | Fu An Pharma Group Hubei Ren Min Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503273 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503272 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2503271 | Chongqing Shi Sen Pharmaceuticals Technology Co., Ltd. romanized; Yan Tai Lu Yin Pharma Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | 左羟丙哌嗪口服溶液 · No verified English nameCYHS2503270 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | Minoxidil LinimentCYHS2503268 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | Fosfomycin Sodium For InjectionCYHS2503267 | Beijing Pin Shang Pin Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2025/09/05Generic · Class 3 | Minoxidil LinimentCYHS2503266 | Sichuan Yi Ke Pharmaceutical Co., Ltd. romanized |
123 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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