YaoGeJu

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

Period
2026/05/12 to 2026/05/18, 7 days inclusive
Data as of
2026/11/13 06:00
Cached records
94,806 acceptance records, 11,656 under review now
Source
Public data from the CDE acceptance list and under-review list
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 typeFilings
Supplement305
Generic104
New drug104
Import19
Unspecified11
Import re-registration11

By drug type

Drug typeFilings
Chemical drug284
TCM176
Therapeutic biologic82
Biologic10
Prophylactic biologic2

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

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)FilingsDrugsGeneric
1Ha Yao Group Bio Gong Cheng Co., Ltd. romanized26100
2Tai Ji Group Chongqing Tong Jun Ge Pharmaceutical Factory Co., Ltd. romanized13110
3Karuna Therapeutics Inc. a Bristol Myers Squibb Company820
4Pi Ai Sai Pharmaceuticals Technology (Shanghai) Co., Ltd. romanized660
5Bao Tou Zhong Yao Co., Ltd. romanized640
6Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized630
7Kyowa Kirin Co. Ltd.610
8Ying Bai Rui (Hangzhou) Biopharmaceuticals Co., Ltd. romanized610
9Guangxi Yu Lin Pharmaceutical Group Co., Ltd. romanized550
10Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized550

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

AcceptedDrugApplicants
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.

Subscribe to the weekly

No account needed.

The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.

A text version of this report, weekly, in the language you subscribe in. You will receive one confirmation email first; sending starts only after you click its link. Every issue carries an unsubscribe link.