YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 554 drug applications between 12 May 2026 and 18 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 104, covering 68 drug names.
2026/05/12 – 2026/05/18
- New acceptances this week
- 554
- Drugs with new generic filings (by drug name, de-duplicated)
- 68
- Accepted this week, now under review
- 158
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
554filings, 104 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 305 |
| Generic | 104 |
| New drug | 104 |
| Import | 19 |
| Unspecified | 11 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 284 |
| TCM | 176 |
| Therapeutic biologic | 82 |
| Biologic | 10 |
| Prophylactic biologic | 2 |
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
68 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sacubitril Valsartan Sodium Tablets | 6 | 2 | 70 |
| 2 | Edaravone and Dexborneol Concentrated Solution for Injection | 3 | 3 | 34 |
| 3 | 瑞维那新吸入溶液 · No verified English name | 3 | 3 | 53 |
| 4 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 5 | Galanthamine Hydrobromide Oral Solution | 3 | 1 | 5 |
| 6 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 7 | Upadacitinib Sustained-release Tablets | 2 | 2 | 43 |
| 8 | 氧(液态) · No verified English name | 2 | 2 | 13 |
| 9 | 二甲硅油乳剂 · No verified English name | 2 | 1 | 14 |
| 10 | 地氯雷他定口服溶液 · No verified English name | 2 | 1 | 26 |
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
312 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 26 | 10 | 0 |
| 2 | Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized | 13 | 11 | 0 |
| 3 | Karuna Therapeutics Inc. a Bristol Myers Squibb Company | 8 | 2 | 0 |
| 4 | Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Bao Tou Zhong Yao Co., Ltd. romanized | 6 | 4 | 0 |
| 6 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 3 | 0 |
| 7 | Kyowa Kirin Co. Ltd. | 6 | 1 | 0 |
| 8 | Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized | 6 | 1 | 0 |
| 9 | Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized | 5 | 5 | 0 |
| 10 | Suzhou Sheng Di Ya Biopharmaceuticals 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
156 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/18Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2601168 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18Generic · Class 3 | Doxycycline Hyclate TabletsCYHS2601167 | Anhui Jie Xi Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18Generic · Class 3 | Relugolix TabletsCYHS2601163 | Shanghai Hui Lun Pharmaceuticals Co., Ltd. romanized; Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2026/05/18Generic · Class 3 | 马沙骨化醇注射液 · No verified English nameCYHL2600061 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2026/05/18New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600085 | Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized |
| 2026/05/18New drug · Class 3.3 | 司美格鲁肽注射液 · No verified English nameCXSS2600084 | Li Zhu Group Xin Bei Jiang Pharmaceutical Co., Ltd. romanized |
| 2026/05/18New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2600544 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2600543 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | 注射用TL001 · No verified English nameCXSL2600542 | Shanghai Tang Ling Biopharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2026/05/18New drug · Class 1 | LM-168注射液 · No verified English nameCXSL2600541 | Li Xin Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | SHR-4610注射液 · No verified English nameCXSL2600540 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | 注射用SHR-1826 · No verified English nameCXSL2600539 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | 注射用SHR-9839(sc) · No verified English nameCXSL2600538 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2600537 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | 注射用FH-006 · No verified English nameCXSL2600536 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Fu Hong Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | 注射用HB0043(皮下注射) · No verified English nameCXSL2600535 | Shanghai Hua Ao Tai Bio Pharma Co., Ltd. romanized; Hua Bo Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | 人脐带间充质干细胞注射液 · No verified English nameCXSL2600534 | Qian Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | QT-019B细胞注射液 · No verified English nameCXSL2600533 | Hangzhou Qi Han Bio Technology Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | LY01620 · No verified English nameCXSL2600532 | Nanjing Ji Mai Bio Technology Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2600589 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2600588 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-7172片 · No verified English nameCXHL2600587 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | CVL218片 · No verified English nameCXHL2600586 | Fu Kang (Hubei Sheng) Bio Technology Kai Fa Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2600585 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-4642注射液 · No verified English nameCXHL2600584 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized; Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | H029片 · No verified English nameCXHL2600583 | Jiangsu Ke Fei Ping Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2600582 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-6093片 · No verified English nameCXHL2600581 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-7058胶囊 · No verified English nameCXHL2600580 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/05/18New drug · Class 1 | HRS-7058胶囊 · No verified English nameCXHL2600579 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
126 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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