YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 306 drug applications between 16 January 2024 and 22 January 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 77, covering 59 drug names.
2024/01/16 – 2024/01/22
- New acceptances this week
- 306
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 2
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
306filings, 77 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 156 |
| Generic | 77 |
| New drug | 51 |
| Import | 14 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 203 |
| TCM | 56 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 3 |
| 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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 注射用头孢唑肟钠 · No verified English name | 4 | 1 | 4 |
| 2 | Calcium Folinate Injection | 3 | 1 | 4 |
| 3 | Diquafosol Sodium Eye Drops | 2 | 2 | 5 |
| 4 | Tadalafil Tablets | 2 | 1 | 23 |
| 5 | Crizotinib Capsules | 2 | 1 | 7 |
| 6 | Piracetam Injection | 2 | 1 | 9 |
| 7 | 复方聚乙二醇电解质散(Ⅱ) · No verified English name | 2 | 1 | 4 |
| 8 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 9 | Sacubitril Valsartan Sodium Tablets | 2 | 1 | 70 |
| 10 | Meropenem for Injection | 2 | 1 | 5 |
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
179 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Gansu Yong He Tang Pharma Co., Ltd. romanized | 16 | 16 | 0 |
| 2 | Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized | 10 | 9 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 9 | 3 | 0 |
| 4 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 4 | 0 |
| 5 | Guangdong Ke Lun Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 6 | Jilin Wu Tai Gan Kang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Jiangxi Nanchang Ji Sheng Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | AstraZeneca AB | 4 | 3 | 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 |
|---|---|---|
| 2024/01/22Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2400291 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2024/01/22New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2400050 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/01/22New drug · Class 1 | 注射用SHR-A2102 · No verified English nameCXSL2400049 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/01/22New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2400048 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/01/22New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2400093 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/01/22New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2400092 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/01/22New drug · Class 1 | HRS8807片 · No verified English nameCXHL2400091 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/01/22New drug · Class 1 | HRS8807片 · No verified English nameCXHL2400090 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/01/22New drug · Class 2.4 | 羟乙磺酸达尔西利片 · No verified English nameCXHL2400089 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/01/20Import · Class 2.2 | 佩索利单抗注射液(皮下注射) · No verified English nameJXSL2400021 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/01/20Import · Class 2.2 | 佩索利单抗注射液 · No verified English nameJXSL2400020 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2024/01/20Generic · Class 3 | Salbutamol Sulfate injectionCYHS2400290 | HUNAN WARRANT PHARMACEUTICAL CO.,LTD |
| 2024/01/20Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2400288 | Ping Guang Pharmaceutical Co., Ltd. romanized |
| 2024/01/20Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2400287 | Ping Guang Pharmaceutical Co., Ltd. romanized |
| 2024/01/20Generic · Class 3 | Ebastine Oral SolutionCYHS2400286 | Shanxi Tong Da Pharma Co., Ltd. romanized |
| 2024/01/20Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2400285 | Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized |
| 2024/01/20Generic · Class 3 | 复方聚乙二醇电解质散(Ⅱ) · No verified English nameCYHS2400284 | Yang Ling Ke Sen Biopharmaceutical Co., Ltd. romanized |
| 2024/01/20Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2400283 | Xian Yuan Da Ke Chuang Pharmaceuticals Technology Co., Ltd. romanized; Xian Yuan Da De Tian Pharma Co., Ltd. romanized |
| 2024/01/20Generic · Class 3 | Betaine anhydrous for oral solutionCYHS2400282 | Beijing Si Li An Pharma Co., Ltd. romanized |
| 2024/01/20Generic · Class 3 | Diprophylline InjectionCYHS2400281 | Anhui Mei Lai Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2024/01/20Generic · Class 3 | Memantine Hydrochloride Oral SolutionCYHS2400280 | Shenyang Tian Bang Pharma Co., Ltd. romanized |
| 2024/01/20New drug · Class 3.1 | 枇杷清肺颗粒 · No verified English nameCXZS2400004 | Zhong Jing Wan Xi Pharmaceutical Co., Ltd. romanized |
| 2024/01/20New drug · Class 3.3 | b型流感嗜血杆菌结合疫苗 · No verified English nameCXSS2400014 | Luo Yi (Wuxi) Biopharmaceutical Co., Ltd. romanized |
| 2024/01/20New drug · Class 2.2 | 注射用卡瑞利珠单抗 · No verified English nameCXSL2400047 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/01/20New drug · Class 1 | 注射用BL-M07D1 · No verified English nameCXSL2400046 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/01/20New drug · Class 1 | 注射用BL-M07D1 · No verified English nameCXSL2400045 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/01/20New drug · Class 1 | XNW5004片 · No verified English nameCXHL2400088 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/01/20New drug · Class 1 | XNW5004片 · No verified English nameCXHL2400087 | Suzhou Xin Nuo Wei Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/01/20New drug · Class 2.4 | 盐酸伊立替康脂质体注射液 · No verified English nameCXHL2400086 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2024/01/19Import · Class 1 | BI 456906 注射液 · No verified English nameJXHL2400020 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
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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