YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 331 drug applications between 19 May 2026 and 25 May 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 23, covering 18 drug names.
2026/05/19 – 2026/05/25
- New acceptances this week
- 331
- Drugs with new generic filings (by drug name, de-duplicated)
- 18
- Accepted this week, now under review
- 38
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
331filings, 23 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 218 |
| New drug | 66 |
| Generic | 23 |
| Import | 10 |
| Unspecified | 7 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| TCM | 164 |
| Chemical drug | 118 |
| Therapeutic biologic | 48 |
| 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
18 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Adapalene And Benzoyl Peroxide Gel | 3 | 2 | 30 |
| 2 | 复方醋酸钠葡萄糖注射液 · No verified English name | 2 | 1 | 8 |
| 3 | Levofloxacin and Sodium Chloride Injection | 2 | 1 | 14 |
| 4 | Procaterol Hydrochloride Oral Solution | 2 | 1 | 12 |
| 5 | Upadacitinib Sustained-release Tablets | 1 | 1 | 43 |
| 6 | Crisaborole Ointment | 1 | 1 | 26 |
| 7 | Carbetocin Injection | 1 | 1 | 6 |
| 8 | 双氯芬酸钠盐酸利多卡因注射液 · No verified English name | 1 | 1 | 8 |
| 9 | 噻托溴铵奥达特罗吸入喷雾剂 · No verified English name | 1 | 1 | 2 |
| 10 | Ibuprofen Suspension | 1 | 1 | 14 |
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
204 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Xian Da Tang Pharmaceutical Group Co., Ltd. romanized | 10 | 10 | 0 |
| 2 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 10 | 5 | 0 |
| 3 | Tong Hua Jin Ma Pharma Group Co., Ltd. romanized | 8 | 7 | 0 |
| 4 | Suzhou Hu Yun Xin Yao Research and Development Co., Ltd. romanized | 7 | 1 | 0 |
| 5 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 6 | Hunan De Kang Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | EUROAPI Germany GmbH | 4 | 4 | 0 |
| 8 | Xiu Zheng Pharma Group (Hunan) Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Shanxi Guang Yu Yuan Guo Yao Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Hubei Dong Xin Pharma Co., Ltd. romanized | 4 | 4 | 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
80 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/05/25Import · Class 2.2 | 伊奈利珠单抗注射液 · No verified English nameJXSL2600120 | Amgen Inc.; Amgen Biotechnology Consultation (Shanghai) CO. Ltd. |
| 2026/05/25Import · Class 1 | PFL-721片 · No verified English nameJXHL2600184 | PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd. |
| 2026/05/25Import · Class 1 | PFL-721片 · No verified English nameJXHL2600183 | PIERRE FABRE MEDICAMENT; Pierre Fabre (Shanghai) Medical Co. Ltd. |
| 2026/05/25New drug · Class 3.1 | 清心莲子饮颗粒 · No verified English nameCXZS2600027 | Yunnan Bai Yao Group Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | NK细胞注射液 · No verified English nameCXSL2600569 | Jing Dong Fang Zai Sheng Yi Xue Technology Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | RJK-RT2831注射液 · No verified English nameCXSL2600568 | Nanjing Rong Jie Kang Bio Technology Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | Tvac001新抗原反应性T细胞注射液 · No verified English nameCXSL2600567 | Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | SGC001注射液 · No verified English nameCXSL2600566 | Beijing Shun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600625 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600624 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600623 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | 炔丙基半胱氨酸胶囊 · No verified English nameCXHL2600622 | Yi Nuo Pharmaceuticals (Guangdong) Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | 注射用Tvac001个性化肿瘤新抗原多肽 · No verified English nameCXHL2600621 | Guangzhou Run Sheng Xi Bao Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/05/25New drug · Class 1 | HZ-V055胶囊 · No verified English nameCXHL2600620 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2026/05/25New drug · Class 1 | HZ-V055胶囊 · No verified English nameCXHL2600619 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2026/05/25New drug · Class 1 | HZ-V055胶囊 · No verified English nameCXHL2600618 | Hangzhou He Zheng Pharmaceuticals Co., Ltd. romanized; Zhongguo Ke College Shanghai Drug Research Institute romanized |
| 2026/05/22Import · Class 1 | DDY391片 · No verified English nameJXHL2600182 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/22Import · Class 1 | DDY391片 · No verified English nameJXHL2600181 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2026/05/22Import · Class 1 | BMS-986458片 · No verified English nameJXHL2600180 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/05/22Import · Class 1 | BMS-986458片 · No verified English nameJXHL2600179 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2026/05/22New drug · Class 1.1 | 黄氏止咳润喉散 · No verified English nameCXZL2600048 | Huang Shi Hou Kang Zhong Pharmaceuticals Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | 注射用BL-B01D1(皮下注射) · No verified English nameCXSL2600565 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | HH160注射液 · No verified English nameCXSL2600564 | Hua Hui An Jian (Beijing) Bio Technology Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | GEB-101 · No verified English nameCXSL2600563 | Beijing Yin Zheng Ji Yin Technology Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | 注射用3SC009 · No verified English nameCXSL2600562 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | QX027N 注射液 · No verified English nameCXSL2600561 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | QX027N 注射液 · No verified English nameCXSL2600560 | Jiangsu Quan Xin Biopharmaceuticals Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | GenSci144片 · No verified English nameCXHL2600617 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | GenSci144片 · No verified English nameCXHL2600616 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2026/05/22New drug · Class 1 | BIOS0635-048片 · No verified English nameCXHL2600615 | Hangzhou Bai Cheng Pharmaceuticals Technology Co., Ltd. romanized |
50 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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