YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 384 drug applications between 29 January 2026 and 4 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 82, covering 59 drug names.
2026/01/29 – 2026/02/04
- New acceptances this week
- 384
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 122
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
384filings, 82 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 210 |
| Generic | 82 |
| New drug | 59 |
| Import | 16 |
| Import re-registration | 9 |
| Unspecified | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| TCM | 106 |
| Therapeutic biologic | 52 |
| Prophylactic biologic | 4 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide Tablets | 5 | 1 | 5 |
| 2 | Cefmetazole Sodium for Injection | 3 | 1 | 7 |
| 3 | 莫立司他钠片 · No verified English name | 3 | 1 | 0 |
| 4 | 氧 · No verified English name | 2 | 2 | 15 |
| 5 | 褪黑素颗粒 · No verified English name | 2 | 2 | 12 |
| 6 | Dapagliflozin Tablets | 2 | 2 | 84 |
| 7 | Fluticasone Propionate Cream | 2 | 1 | 12 |
| 8 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 9 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 10 | 左羟丙哌嗪口服溶液 · No verified English name | 2 | 1 | 8 |
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
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 16 | 8 | 0 |
| 2 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 12 | 12 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 9 | 3 | 0 |
| 4 | Shen Wei Pharma Group Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 6 | 6 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 4 | 0 |
| 7 | Bayer AG | 6 | 2 | 0 |
| 8 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized | 6 | 2 | 0 |
| 9 | Novo Nordisk A/S | 6 | 1 | 0 |
| 10 | Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 5 | 5 | 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
103 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/02/04Generic · Class 3 | Bifonazole SolutionCYHS2600356 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | 托吡酯口服溶液 · No verified English nameCYHS2600354 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Anhui Yong Sheng Tang Pharma Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600353 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600352 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600351 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600350 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | Olmesartan Medoxomil and Amlodipine and Hydrochlorothiazide TabletsCYHS2600349 | Shanghai Teng Rui Pharmaceutical Co., Ltd. romanized; Guangzhou Bo Si Tao Kong Shi Pharma Co., Ltd. romanized |
| 2026/02/04Generic · Class 3 | 氨氯地平缬沙坦氢氯噻嗪片 · No verified English nameCYHL2600020 | Chengdu Di Ao Pharmaceutical Group Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | IBI3031 · No verified English nameCXSL2600167 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | NEWR0919滴眼液 · No verified English nameCXSL2600166 | Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | NEWR0919滴眼液 · No verified English nameCXSL2600165 | Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | NEWR0919滴眼液 · No verified English nameCXSL2600164 | Shenzhen Xin Rui Ji Yin Technology Co., Ltd. romanized |
| 2026/02/04New drug · Class 2.4 | 芦沃美替尼片 · No verified English nameCXHS2600025 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2026/02/04New drug · Class 2.4 | 芦沃美替尼片 · No verified English nameCXHS2600024 | Shanghai Fu Xing Pharmaceuticals Industry Development Co., Ltd. romanized; Kai Lai Ying Sheng Ming Ke Xue Technology (Tianjin) Co., Ltd. romanized |
| 2026/02/04New drug · Class 2.2 | HR091506片 · No verified English nameCXHS2600023 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/04New drug · Class 2.2 | HR091506片 · No verified English nameCXHS2600022 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | 甲磺酸奥达替尼胶囊 · No verified English nameCXHS2600021 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | 甲磺酸奥达替尼胶囊 · No verified English nameCXHS2600020 | Jiangsu Zheng Da Feng Hai Pharmaceutical Co., Ltd. romanized; Jiangsu Hua Yang Pharmaceutical Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | SIR9900片 · No verified English nameCXHL2600144 | Wei Tai Rui Long (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | JAB-8263片 · No verified English nameCXHL2600143 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2026/02/04New drug · Class 1 | JAB-8263片 · No verified English nameCXHL2600142 | Beijing Jia Ke Si Xin Yao Research and Development Co., Ltd. romanized |
| 2026/02/03Import · Class 1 | BI 764532 输注用浓缩粉末 · No verified English nameJXSL2600037 | Boehringer lngelheim International GmbH; Boehringer lngelheim (China) Investment Co. Ltd. |
| 2026/02/03Generic · Class 3 | Ketorolac Trometamol TabletsCYHS2600346 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/02/03Generic · Class 3 | Torsemide InjectionCYHS2600341 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2026/02/03Generic · Class 3 | 盐酸舍曲林口服浓缩液 · No verified English nameCYHS2600340 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2026/02/03Generic · Class 3 | 复方匹可硫酸钠颗粒 · No verified English nameCYHS2600339 | Zhejiang Hao Ge Pharma Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/02/03New drug · Class 1 | 注射用GenSci136 · No verified English nameCXSL2600163 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/02/03New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2600162 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/03New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2600161 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/03New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2600160 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
73 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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