YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 367 drug applications between 28 January 2026 and 3 February 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 63, covering 48 drug names.
2026/01/28 – 2026/02/03
- New acceptances this week
- 367
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- Accepted this week, now under review
- 99
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
367filings, 63 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 216 |
| Generic | 63 |
| New drug | 57 |
| Import | 15 |
| Unspecified | 8 |
| Import re-registration | 8 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 192 |
| TCM | 109 |
| Therapeutic biologic | 59 |
| 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
48 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cefmetazole Sodium for Injection | 3 | 1 | 7 |
| 2 | 莫立司他钠片 · No verified English name | 3 | 1 | 0 |
| 3 | 褪黑素颗粒 · No verified English name | 2 | 2 | 12 |
| 4 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 5 | 左羟丙哌嗪口服溶液 · No verified English name | 2 | 1 | 8 |
| 6 | Empagliflozin Tablets | 2 | 1 | 18 |
| 7 | Galantamine Hydrobromide Tablets | 2 | 1 | 2 |
| 8 | 注射用头孢他啶/氯化钠注射液 · No verified English name | 2 | 1 | 3 |
| 9 | Doxycycline Hyclate for Injection | 2 | 1 | 11 |
| 10 | 盐酸特比萘芬喷雾剂 · No verified English name | 2 | 1 | 7 |
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
211 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 | 14 | 14 | 0 |
| 3 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 7 | 2 | 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 | Novo Nordisk A/S | 6 | 1 | 0 |
| 9 | Guangxi Wu Zhou Pharmaceutical (Group) Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Da Jia Wei Kang Biopharmaceutical 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
95 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2026/02/03New drug · Class 1 | SAL0896注射液 · No verified English nameCXSL2600159 | Nanjing Sai Le Si Biopharmaceutical Co., Ltd. romanized |
| 2026/02/03New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600158 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/02/03New drug · Class 1 | 注射用FH-006 · No verified English nameCXSL2600157 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized |
| 2026/02/03New drug · Class 1 | 注射用HY016 · No verified English nameCXHL2600141 | Tianjin Bo Tai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/03New drug · Class 2.2 | 葡萄糖迟释片 · No verified English nameCXHL2600140 | Zhejiang Han Mai Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/02/03New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2600139 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/03New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2600138 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/02/02New drug · Class 1 | HX102片 · No verified English nameCXHL2600137 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2026/02/02New drug · Class 1 | HX102片 · No verified English nameCXHL2600136 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2026/01/31Import · Class 1 | PF-08634404 · No verified English nameJXSL2600036 | Pfizer Inc.; Pfizer (Beijing) Research and Development Co. Ltd. |
| 2026/01/31Import · Class 1 | PF-08046047 · No verified English nameJXSL2600035 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/01/31Import · Class 1 | PF-08046054 (注射用冻干粉针) · No verified English nameJXSL2600034 | Pfizer Inc.; Pfizer Investment CO. Ltd. |
| 2026/01/31Import · Class 1 | BMS-986504片 · No verified English nameJXHL2600031 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/01/31Generic · Class 3 | Galantamine Hydrobromide TabletsCYHS2600329 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | Galantamine Hydrobromide TabletsCYHS2600328 | Hangzhou Kang En Bei Pharmaceutical Co., Ltd. romanized; Zhejiang Jin Hua Kang En Bei Biopharmaceutical Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | Etoposide InjectionCYHS2600327 | Wuxi Zi Shan Pharma Co., Ltd. romanized; Hefei Yi Fan Biopharmaceutical Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2600321 | Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | Carbocisteine Oral SolutionCYHS2600320 | Chengdu Giantech Hi-technology Development Co., Ltd.; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/01/31Generic · Class 3 | Doxycycline Hyclate for InjectionCYHS2600319 | Hainan Wei Kang Pharmaceutical (Qian Shan) Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | 莫立司他钠片 · No verified English nameCYHL2600019 | Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized |
| 2026/01/31Generic · Class 3 | 莫立司他钠片 · No verified English nameCYHL2600018 | Shanghai Bo Zhi Yan Xin Drug Research Co., Ltd. romanized |
65 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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